Home NDC 0641-6121-01 Ampicillin and Sulbactam
Product NDC 0641-6121
Requested package NDC 0641-6121-01
11-digit product format 006416121
Labeler code 0641
Product ID 0641-6121_68fc19c6-3431-4c1d-bd50-b685aae800d6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ampicillin and Sulbactam
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler West-Ward Pharmaceuticals Corp.
Application ANDA065403
Marketing category ANDA
Marketing start 2009-12-03
Marketing end 0000-00-00
Substance AMPICILLIN SODIUM; SULBACTAM SODIUM
Active strength 100 mg/mL; mg/mL
Pharmacologic classes Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]
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 · 5 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…
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 A065403-001 AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065403-001 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 A065403-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065403-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065403-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065403-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065403-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065403-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065403-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065403-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065403-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065403-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065403-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065403-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065403-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065403-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065403-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065403-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065403-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065403-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065403-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065403-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065403-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065403-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065403-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065403-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065403-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065403-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065403-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065403-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065403-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065403-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065403-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065403-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065403-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065403-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065403-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065403-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065403-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065403-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065403-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A065403-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-23 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AMPICILLIN SODIUM ACTIVE INGREDIENT JFN36L5S8K AMPICILLIN AND SULBACTAM INJECTION, POWDER, FOR SOLUTION [WEST-WARD PHARMACEUTICAL CORP.] 5 SULBACTAM SODIUM ACTIVE INGREDIENT DKQ4T82YE6 AMPICILLIN AND SULBACTAM INJECTION, POWDER, FOR SOLUTION [WEST-WARD PHARMACEUTICAL CORP.] 5 AMPICILLIN ACTIVE MOIETY 7C782967RD AMPICILLIN AND SULBACTAM INJECTION, POWDER, FOR SOLUTION [WEST-WARD PHARMACEUTICAL CORP.] 5 SULBACTAM ACTIVE MOIETY S4TF6I2330 AMPICILLIN AND SULBACTAM INJECTION, POWDER, FOR SOLUTION [WEST-WARD PHARMACEUTICAL CORP.] 5
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 Units Marketing start Marketing end Sample Exclude flag Status 0641-6121-01 00641612101 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (0641-6121-01) 100 ml 2009-12-03 0000-00-00 No No Current