Home NDC 72485-418 Ampicillin Sodium and Sulbactam Sodium
Product NDC 72485-418
11-digit product format 724850418
Labeler code 72485
Product ID 72485-418_44e29e92-b036-b2f8-e063-6394a90a7f6a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ampicillin sodium, sulbactam sodium
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Armas Pharmaceuticals Inc.
Application ANDA202197
Marketing category ANDA
Marketing start 2025-05-01
Substance AMPICILLIN SODIUM; SULBACTAM SODIUM
Active strength 10; 5 g/15g; g/15g
Pharmacologic classes Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A202197-001 AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM EQ 10GM BASE/VIAL;EQ 5GM 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 A202197-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A202197-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202197-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202197-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202197-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202197-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202197-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202197-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202197-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202197-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202197-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202197-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202197-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202197-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202197-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202197-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202197-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202197-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202197-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202197-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202197-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202197-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202197-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202197-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202197-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202197-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202197-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202197-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202197-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202197-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202197-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202197-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202197-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202197-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202197-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202197-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202197-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202197-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202197-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202197-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202197-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Ampicillin Sodium and Sulbactam Sodium
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMPICILLIN SODIUM 10 g/15g SULBACTAM SODIUM 5 g/15g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination JFN36L5S8K Internal UNII lookup DKQ4T82YE6 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 240984 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72485-418-15 Ampicillin Sodium and Sulbactam Sodium 15 g in 1 BOTTLE INJECTION, POWDER, FOR SOLUTION 15 2 72485-418-15 Ampicillin Sodium and Sulbactam Sodium 1 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72485-418 AMPICILLIN SODIUM AND SULBACTAM SODIUM (AMPICILLIN SODIUM, SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [ARMAS PHARMACEUTICALS INC.] 1 Current NDC, 2 package rows 20250523_409f8a6d-f54f-415f-994c-ecd2b820caab.zip
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72485-418-15 72485041815 1 BOTTLE in 1 CARTON (72485-418-15) / 15 g in 1 BOTTLE 1 bottle 2025-05-01 No No Current