Home NDC 17478-608 Bacitracin
Product NDC 17478-608
11-digit product format 174780608
Labeler code 17478
Product ID 17478-608_bf71d10a-1f13-4266-bee8-1b473223e99c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bacitracin
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAMUSCULAR
Labeler Akorn, Inc.
Application ANDA206719
Marketing category ANDA
Marketing start 2017-10-23
Marketing end 0000-00-00
Substance BACITRACIN A
Active strength 5000 [USP'U]/mL
NDC exclude flag No
Listing certified through 2021-12-31
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 · 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 17478-608-30 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 17478-608-30 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 17478-608-30 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 17478-608-30 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 17478-608-30 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 17478-608-30 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 17478-608-30 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 17478-608-30 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 17478-608-30 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 17478-608-30 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 17478-608-30 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 17478-608-30 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 A206719-001 BACITRACIN 50,000 UNITS/VIAL INJECTABLE / INJECTION 2017-10-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206719-001 BACITRACIN 50,000 UNITS/VIAL INJECTABLE / INJECTION 2017-10-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206719-001 BACITRACIN 50,000 UNITS/VIAL INJECTABLE / INJECTION 2017-10-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206719-001 BACITRACIN 50,000 UNITS/VIAL INJECTABLE / INJECTION AP 2017-10-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206719-001 BACITRACIN 50,000 UNITS/VIAL INJECTABLE / INJECTION 2017-10-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206719-001 BACITRACIN 50,000 UNITS/VIAL INJECTABLE / INJECTION 2017-10-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206719-001 BACITRACIN 50,000 UNITS/VIAL INJECTABLE / INJECTION 2017-10-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206719-001 BACITRACIN 50,000 UNITS/VIAL INJECTABLE / INJECTION 2017-10-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206719-001 BACITRACIN 50,000 UNITS/VIAL INJECTABLE / INJECTION 2017-10-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206719-001 BACITRACIN 50,000 UNITS/VIAL INJECTABLE / INJECTION 2017-10-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206719-001 BACITRACIN 50,000 UNITS/VIAL INJECTABLE / INJECTION AP 2017-10-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206719-001 BACITRACIN 50,000 UNITS/VIAL INJECTABLE / INJECTION AP 2017-10-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206719-001 BACITRACIN 50,000 UNITS/VIAL INJECTABLE / INJECTION AP 2017-10-20 ea99ee380514…2022-09-29 23:25 UTC 2022-09 A206719-001 BACITRACIN 50,000 UNITS/VIAL INJECTABLE / INJECTION 2017-10-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A206719-001 BACITRACIN 50,000 UNITS/VIAL INJECTABLE / INJECTION 2017-10-20 cb3db0bc1861…
Observed Orange Book normalized TE history# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 17478-608-30 17478060830 1 VIAL in 1 CARTON (17478-608-30) > 10 mL in 1 VIAL 1 vial 2017-10-23 0000-00-00 No No Current