Home NDC 67457-404-10 Ampicillin Sodium
Product NDC 67457-404
Requested package NDC 67457-404-10
11-digit product format 674570404
Labeler code 67457
Product ID 67457-404_02a590f3-e725-4fe0-a130-d5342ca6f759
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ampicillin Sodium
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Mylan Institutional LLC
Application ANDA202198
Marketing category ANDA
Marketing start 2016-09-12
Marketing end 2023-09-30
Substance AMPICILLIN SODIUM
Active strength 10 g/100mL
Pharmacologic classes Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag No
Listing certified through 0000-00-00
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202198-001 AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202198-001 AP
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.
Product history page 1 of 2 · 41 observed 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 2026-02-19 14:30 UTC 2026-02 A202198-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202198-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202198-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202198-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202198-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202198-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202198-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202198-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202198-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202198-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202198-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202198-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202198-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202198-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202198-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202198-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202198-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202198-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202198-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202198-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202198-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202198-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202198-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202198-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202198-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202198-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202198-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202198-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202198-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202198-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202198-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202198-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202198-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202198-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202198-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202198-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202198-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202198-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202198-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A202198-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 67457-404-10 67457040410 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67457-404-10) > 100 mL in 1 VIAL, PHARMACY BULK PACKAGE 2016-09-12 2023-09-30 No No Current