NAICS 325412

Overview

The North American Industry Classification System (NAICS) is the federal standard for classifying business establishments for U.S. economic statistics. Developed by the Office of Management and Budget’s Economic Classification Policy Committee with Statistics Canada and Mexico’s INEGI, NAICS replaced the SIC system in 1997 to improve cross‑country comparability and data consistency. ¹

U.S. industry 325412 covers manufacturing of in‑vivo diagnostic substances and non‑biological pharmaceutical preparations in finished dosage forms (for internal or external use), such as ampoules, tablets, capsules, vials, ointments, powders, solutions, and suspensions. Agencies and data programs use this code under the 2022 NAICS vintage to tabulate and report industry statistics and boundaries. ²

See also on G2X:

• G2X — NAICS 325412 overview
• G2X — NAICS 325411
• G2X — NAICS 325414

What this NAICS covers

• Finished‑dosage pharmaceutical manufacturing (e.g., tablets, capsules, ampoules, vials, ointments, powders, solutions, suspensions). ²
• Non‑biological pharmaceutical preparations intended for internal or external consumption. ²
• In‑vivo diagnostic substance manufacturing. ²
• Packaged, compounded medicinals and botanicals classified as manufactured pharmaceutical preparations. ²
• Formulation and processing of non‑biologic medicines distinct from bulk uncompounded chemicals. ²
• Excludes in‑vitro diagnostic substances (classified in 325413). ²
• Excludes vaccines, toxoids, blood fractions, and other biologicals (classified in 325414). ²

Related NAICS and PSC codes

Type	Code	Descriptor
NAICS	325411	Medicinal and Botanical Manufacturing
NAICS	325413	In‑Vitro Diagnostic Substance Manufacturing
NAICS	325414	Biological Product (except Diagnostic) Manufacturing
PSC	6505	Drugs and Biologicals

SBA small business size standard

For NAICS 325412, SBA’s small business size standard is 1,300 employees (effective March 17, 2023). ⁴

Key boundaries and cross‑references

• Bulk, uncompounded medicinal chemicals and botanical grading/milling are classified in 325411. ²
• In‑vitro diagnostic substances belong in 325413. ²
• Vaccines, toxoids, and other non‑diagnostic biological products are in 325414. ²
• Retail pharmacies, including those that dispense medicines, are classified under 446110 Pharmacies and Drug Stores, not manufacturing. ⁶

Frequently asked questions

• What activities define NAICS 325412?
  Manufacturing of non‑biologic pharmaceutical preparations and in‑vivo diagnostic substances in finished dosage forms (e.g., tablets, capsules, vials, ointments, solutions, suspensions). These products are intended for internal or external consumption. ²

• How is 325412 different from 325414?
  Code 325412 excludes biologics such as vaccines, toxoids, and blood fractions; those are classified in 325414. The distinction hinges on biological versus non‑biological preparations and diagnostic purpose. ²

• Are in‑vitro diagnostics included in 325412?
  No. In‑vitro diagnostic substances are classified under 325413, while 325412 covers in‑vivo diagnostic substances and pharmaceutical preparations. ²

• What is the SBA small business size threshold for 325412?
  SBA sets the size standard at 1,300 employees for NAICS 325412, per the March 17, 2023 Table of Small Business Size Standards. ⁴

Useful resources

• Census NAICS 2022 — official industry page for NAICS 325412: formal definition, illustrative examples, and cross‑references to adjacent codes. ²
• 2022 NAICS Manual (PDF) — complete structure and definitions for Subsector 3254 and Industry 325412; useful for boundary questions and exclusions. ³
• NAICS search and drill‑down tool — explore definitions, notes, and related industries; helpful for validating whether activities align with 325412. ⁵
• 2022 ↔ 2017 NAICS concordance — map historical code changes affecting pharmaceutical manufacturing classifications when analyzing longitudinal data. ⁷
• SBA Table of Small Business Size Standards — confirm the current employee‑based size standard for NAICS 325412 when planning set‑aside strategies. ⁴
• eCFR — 21 CFR Part 211 (cGMP for Finished Pharmaceuticals) — core quality system requirements relevant to finished‑dosage manufacturers under 325412. ⁸
• FDA Orange Book — Approved Drug Products with Therapeutic Equivalence Evaluations; useful to scope finished dosage forms and reference‑listed drugs in this industry. ⁹
• FDA National Drug Code (NDC) Directory — identify labelers and finished drug products; supports market scans for dosage forms typical of 325412. ¹⁰
• FDA Drugs@FDA — NDAs/ANDAs, labeling, and approval histories; a research aid for competitive and pipeline assessments tied to finished pharmaceuticals. ¹¹
• Product and Service Codes (PSC) Manual — definitions and selection guidance for PSCs related to drug buys (e.g., 6505), supporting NAICS–PSC alignment in solicitations. ¹²

References

1. U.S. Census Bureau. NAICS Background. https://www.census.gov/naics/background.html
2. U.S. Census Bureau. NAICS 2022 — Industry definition and examples for Pharmaceutical Preparation Manufacturing. https://www.census.gov/naics/?input=325412&year=2022
3. U.S. Census Bureau. NAICS 2022 Manual (PDF). https://www.census.gov/naics/reference_files_tools/2022/NAICS_2022_Manual.pdf
4. U.S. Small Business Administration. Table of Small Business Size Standards (effective March 17, 2023) (PDF). https://www.sba.gov/sites/sbagov/files/2023-03/Table-of-Size-Standards_Effective_March_17_2023.pdf
5. U.S. Census Bureau. NAICS Search and Drill‑Down Tool (2022). https://www.census.gov/naics/?year=2022
6. U.S. Census Bureau. NAICS 2022 — Industry page: Pharmacies and Drug Stores. https://www.census.gov/naics/?input=446110&year=2022
7. U.S. Census Bureau. NAICS Concordances (including 2022 ↔ 2017). https://www.census.gov/naics/concordances/concordances.html
8. Electronic Code of Federal Regulations. 21 CFR Part 211 — Current Good Manufacturing Practice for Finished Pharmaceuticals. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211
9. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-approved-drug-products-therapeutic-equivalence-evaluations
10. U.S. Food and Drug Administration. National Drug Code (NDC) Directory. https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory
11. U.S. Food and Drug Administration. Drugs@FDA: FDA‑Approved Drug Products database. https://www.accessdata.fda.gov/scripts/cder/daf/
12. U.S. General Services Administration. Product and Service Codes (PSC) Manual. https://www.acquisition.gov/psc-manual