Bacitracin

Product NDC: 39822-0278
11-digit product format: 398220278
Labeler code: 39822
Product ID: 39822-0278_be6f0d9b-e9ee-4d3c-b589-377461a7595e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bacitracin
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAMUSCULAR
Labeler: X-GEN Pharmaceuticals, Inc.
Application: ANDA203177
Marketing category: ANDA
Marketing start: 2015-10-08
Marketing end: 0000-00-00
Substance: BACITRACIN
Active strength: 50000 [USP'U]/1
Pharmacologic classes: Decreased Cell Wall Synthesis & Repair [PE]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	39822-0278		D	Discontinued by firm		2026-09-14
excluded package	package	39822-0278	39822-0278-1	D	Discontinued by firm		2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	39822-0278-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	39822-0278-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	39822-0278-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	39822-0278-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	39822-0278-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	39822-0278-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	39822-0278-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	39822-0278-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	39822-0278-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	39822-0278-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	39822-0278-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	39822-0278-1	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203177-001	BACITRACIN	50,000 UNITS/VIAL	INJECTABLE / INJECTION			2014-08-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203177-001	BACITRACIN	50,000 UNITS/VIAL	INJECTABLE / INJECTION			2014-08-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203177-001	BACITRACIN	50,000 UNITS/VIAL	INJECTABLE / INJECTION			2014-08-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203177-001	BACITRACIN	50,000 UNITS/VIAL	INJECTABLE / INJECTION	AP		2014-08-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203177-001	BACITRACIN	50,000 UNITS/VIAL	INJECTABLE / INJECTION			2014-08-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203177-001	BACITRACIN	50,000 UNITS/VIAL	INJECTABLE / INJECTION			2014-08-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203177-001	BACITRACIN	50,000 UNITS/VIAL	INJECTABLE / INJECTION		RS	2014-08-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203177-001	BACITRACIN	50,000 UNITS/VIAL	INJECTABLE / INJECTION		RS	2014-08-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203177-001	BACITRACIN	50,000 UNITS/VIAL	INJECTABLE / INJECTION		RS	2014-08-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203177-001	BACITRACIN	50,000 UNITS/VIAL	INJECTABLE / INJECTION		RS	2014-08-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203177-001	BACITRACIN	50,000 UNITS/VIAL	INJECTABLE / INJECTION	AP		2014-08-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203177-001	BACITRACIN	50,000 UNITS/VIAL	INJECTABLE / INJECTION	AP		2014-08-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203177-001	BACITRACIN	50,000 UNITS/VIAL	INJECTABLE / INJECTION	AP		2014-08-25	`ea99ee380514…`
2022-09-29 23:25 UTC	2022-09	A203177-001	BACITRACIN	50,000 UNITS/VIAL	INJECTABLE / INJECTION			2014-08-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203177-001	BACITRACIN	50,000 UNITS/VIAL	INJECTABLE / INJECTION			2014-08-25	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A203177-001	AP	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A203177-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203177-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203177-001	AP	1	`ea99ee380514…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
39822-0278-1	EA - Each	39822-0278	a9dbf81d-cd48-4779-9e4c-235c61d1c21c	1	2016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
BACITRACIN	ACTIVE INGREDIENT	58H6RWO52I	BACITRACIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [X-GEN PHARMACEUTICALS, INC.]	4
BACITRACIN	ACTIVE MOIETY	58H6RWO52I	BACITRACIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [X-GEN PHARMACEUTICALS, INC.]	4

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
58H6RWO52I	BACITRACIN	1405-87-4	BACITRACIN

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bacitracin for Injection, USP	X-GEN Pharmaceuticals, Inc.	2015-10-05	HUMAN PRESCRIPTION DRUG LABEL	5