Home NDC 63323-329-31 Bacitracin
Product NDC 63323-329
Requested package NDC 63323-329-31
11-digit product format 633230329
Labeler code 63323
Product ID 63323-329_9b0228ed-8328-724a-e053-2995a90a9932
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name BACITRACIN
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAMUSCULAR
Labeler Fresenius Kabi USA, LLC
Application ANDA065116
Marketing category ANDA
Marketing start 2003-01-28
Marketing end 0000-00-00
Substance BACITRACIN
Active strength 50000 [iU]/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 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 · 13 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2022-08-30 03:57 UTC · source 2022-08-29 E Excluded after deficient or non-compliant submission was not corrected fb8cb913e6d1…eb8c232b6be0…
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 A065116-001 BACITRACIN 50,000 UNITS/VIAL INJECTABLE / INJECTION 2002-12-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065116-001 BACITRACIN 50,000 UNITS/VIAL INJECTABLE / INJECTION 2002-12-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065116-001 BACITRACIN 50,000 UNITS/VIAL INJECTABLE / INJECTION 2002-12-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065116-001 BACITRACIN 50,000 UNITS/VIAL INJECTABLE / INJECTION AP 2002-12-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065116-001 BACITRACIN 50,000 UNITS/VIAL INJECTABLE / INJECTION 2002-12-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065116-001 BACITRACIN 50,000 UNITS/VIAL INJECTABLE / INJECTION 2002-12-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065116-001 BACITRACIN 50,000 UNITS/VIAL INJECTABLE / INJECTION 2002-12-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065116-001 BACITRACIN 50,000 UNITS/VIAL INJECTABLE / INJECTION 2002-12-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065116-001 BACITRACIN 50,000 UNITS/VIAL INJECTABLE / INJECTION 2002-12-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065116-001 BACITRACIN 50,000 UNITS/VIAL INJECTABLE / INJECTION 2002-12-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065116-001 BACITRACIN 50,000 UNITS/VIAL INJECTABLE / INJECTION AP 2002-12-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065116-001 BACITRACIN 50,000 UNITS/VIAL INJECTABLE / INJECTION AP 2002-12-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065116-001 BACITRACIN 50,000 UNITS/VIAL INJECTABLE / INJECTION AP 2002-12-03 ea99ee380514…2022-09-29 23:25 UTC 2022-09 A065116-001 BACITRACIN 50,000 UNITS/VIAL INJECTABLE / INJECTION 2002-12-03 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A065116-001 BACITRACIN 50,000 UNITS/VIAL INJECTABLE / INJECTION 2002-12-03 cb3db0bc1861…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63323-329-31 63323032931 10 VIAL in 1 CARTON (63323-329-31) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL 10 vial 2003-01-28 0000-00-00 No No Current