Home NDC 0781-3034 Ampicillin and Sulbactam
Product NDC 0781-3034
11-digit product format 007813034
Labeler code 0781
Product ID 0781-3034_7f7373a2-f956-4301-a4bd-20dbf1a92868
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ampicillin sodium and Sulbactam sodium
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Sandoz Inc
Application ANDA065240
Marketing category ANDA
Marketing start 2006-07-25
Marketing end 0000-00-00
Substance AMPICILLIN SODIUM; SULBACTAM SODIUM
Active strength 10 g/1; g/1
Pharmacologic classes Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]
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 · 48 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 product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0781-3034-46 d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0781-3034-46 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 product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0781-3034-46 f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0781-3034-46 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 product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0781-3034-46 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0781-3034-46 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 product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0781-3034-46 a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0781-3034-46 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 product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0781-3034-46 cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0781-3034-46 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 product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0781-3034-46 cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0781-3034-46 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 product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0781-3034-46 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0781-3034-46 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 product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0781-3034-46 ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0781-3034-46 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 product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0781-3034-46 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0781-3034-46 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 product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0781-3034-46 ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0781-3034-46 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 product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0781-3034-46 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0781-3034-46 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 product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0781-3034-46 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0781-3034-46 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A065240-001 AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065240-001 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 · 44 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 2026-10-15 13:18:30 2026-09 A065240-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 c2088c7a36db…2026-09-14 22:38:34 2026-08 A065240-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A065240-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065240-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065240-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065240-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065240-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065240-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065240-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065240-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065240-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065240-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065240-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065240-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065240-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065240-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065240-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065240-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065240-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065240-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065240-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065240-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065240-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065240-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065240-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065240-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065240-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065240-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065240-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065240-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065240-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065240-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065240-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065240-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065240-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065240-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065240-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065240-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065240-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065240-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AMPICILLIN SODIUM ACTIVE INGREDIENT JFN36L5S8K AMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [SANDOZ INC] 15 SULBACTAM SODIUM ACTIVE INGREDIENT DKQ4T82YE6 AMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [SANDOZ INC] 15 AMPICILLIN ACTIVE MOIETY 7C782967RD AMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [SANDOZ INC] 15 SULBACTAM ACTIVE MOIETY S4TF6I2330 AMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [SANDOZ INC] 15
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0781-3034-46 00781303446 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE (0781-3034-46) 2006-07-25 0000-00-00 No No Current