Bacitracin

Product NDC
72572-025
11-digit product format
725720025
Labeler code
72572
Product ID
72572-025_934bb51d-4542-42ef-97e2-b4946d696a27
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bacitracin
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR
Labeler
Civica, Inc.
Application
ANDA203177
Marketing category
ANDA
Marketing start
2019-12-01
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
2021-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct72572-025DDiscontinued by firm2026-08-17
excluded packagepackage72572-02572572-025-10DDiscontinued by firm2026-08-17

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage72572-025-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage72572-025-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage72572-025-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage72572-025-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage72572-025-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage72572-025-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage72572-025-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage72572-025-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage72572-025-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage72572-025-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage72572-025-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage72572-025-10557ba5c1ecfa…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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203177-001BACITRACIN50,000 UNITS/VIALINJECTABLE / INJECTION2014-08-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203177-001BACITRACIN50,000 UNITS/VIALINJECTABLE / INJECTION2014-08-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203177-001BACITRACIN50,000 UNITS/VIALINJECTABLE / INJECTION2014-08-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203177-001BACITRACIN50,000 UNITS/VIALINJECTABLE / INJECTIONAP2014-08-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203177-001BACITRACIN50,000 UNITS/VIALINJECTABLE / INJECTION2014-08-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203177-001BACITRACIN50,000 UNITS/VIALINJECTABLE / INJECTION2014-08-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203177-001BACITRACIN50,000 UNITS/VIALINJECTABLE / INJECTIONRS2014-08-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A203177-001BACITRACIN50,000 UNITS/VIALINJECTABLE / INJECTIONRS2014-08-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203177-001BACITRACIN50,000 UNITS/VIALINJECTABLE / INJECTIONRS2014-08-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203177-001BACITRACIN50,000 UNITS/VIALINJECTABLE / INJECTIONRS2014-08-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203177-001BACITRACIN50,000 UNITS/VIALINJECTABLE / INJECTIONAP2014-08-253f01610625f2…
2019-09-15 20:21 UTC2019-09A203177-001BACITRACIN50,000 UNITS/VIALINJECTABLE / INJECTIONAP2014-08-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A203177-001BACITRACIN50,000 UNITS/VIALINJECTABLE / INJECTIONAP2014-08-25ea99ee380514…
2022-09-29 23:25 UTC2022-09A203177-001BACITRACIN50,000 UNITS/VIALINJECTABLE / INJECTION2014-08-25e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203177-001BACITRACIN50,000 UNITS/VIALINJECTABLE / INJECTION2014-08-25cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A203177-001AP174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A203177-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A203177-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A203177-001AP1ea99ee380514…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72572-025-102023-05-18C16284748780-1f386c649-b4c8-0266-e053-dadaa90a7c1aBacitracin for Injection, USP
72572-025-102023-01-30C16284748780-1f386c649-b4c8-0266-e053-dadaa90a7c1aBacitracin for Injection, USP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72572-025-01EA - Each72572-025d6b9d858-2a46-4185-a700-118067960c8b12020-02-13
72572-025-10EA - Each72572-025a65e80cb-ae2f-4cea-96f0-2756cb2cb67b12020-02-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72572-025-107257200251010 VIAL, GLASS in 1 CARTON (72572-025-10) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (72572-025-01) 2019-12-010000-00-00NoNoCurrent