Home NDC 72485-416 Ampicillin Sodium and Sulbactam Sodium
Product NDC 72485-416
11-digit product format 724850416
Labeler code 72485
Product ID 72485-416_44a1fdb7-5659-23bc-e063-6294a90a1ccd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ampicillin sodium, sulbactam sodium
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Armas Pharmaceuticals Inc.
Application ANDA201024
Marketing category ANDA
Marketing start 2023-07-21
Substance AMPICILLIN SODIUM; SULBACTAM SODIUM
Active strength 1; .5 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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A201024-001 AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 A201024-002 AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 82 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 A201024-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201024-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201024-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201024-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201024-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201024-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201024-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201024-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201024-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201024-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201024-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201024-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201024-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201024-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201024-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201024-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201024-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201024-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201024-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A201024-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201024-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201024-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201024-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201024-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201024-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201024-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201024-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A201024-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201024-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201024-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201024-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A201024-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201024-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A201024-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201024-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A201024-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201024-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A201024-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201024-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A201024-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2014-04-07 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
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 1 g/1 SULBACTAM SODIUM .5 g/1
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1659592 Internal RxNorm lookup 1659598 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 72485-416-01 Ampicillin Sodium and Sulbactam Sodium 1 in 1 VIAL INJECTION, POWDER, FOR SOLUTION 1 4 72485-416-10 Ampicillin Sodium and Sulbactam Sodium 10 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 10 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72485-416 AMPICILLIN SODIUM AND SULBACTAM SODIUM (AMPICILLIN SODIUM, SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [ARMAS PHARMACEUTICALS INC.] 3 Current NDC, 2 package rows 20241030_ac6f8158-9d7e-4b99-af3c-0407c5287b57.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 · 3 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 72485-416-01 72485041601 1 in 1 VIAL Historical 72485-416-10 72485041610 10 VIAL in 1 CARTON (72485-416-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (72485-416-01) 10 vial 2023-07-21 No No Current