Home NDC 55150-118 Ampicillin and Sulbactam
Product NDC 55150-118
11-digit product format 551500118
Labeler code 55150
Product ID 55150-118_4681869d-6a9c-4aaf-90e2-090469e45012
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ampicillin Sodium and Sulbactam Sodium
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Eugia US LLC
Application ANDA090339
Marketing category ANDA
Marketing start 2012-02-10
Substance AMPICILLIN SODIUM; SULBACTAM SODIUM
Active strength 100; 50 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 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090339-001 AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2010-09-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090339-001 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 A090339-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2010-09-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090339-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2010-09-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090339-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2010-09-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090339-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2010-09-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090339-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2010-09-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090339-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2010-09-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090339-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2010-09-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090339-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2010-09-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090339-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2010-09-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090339-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2010-09-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090339-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2010-09-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090339-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2010-09-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090339-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2010-09-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090339-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2010-09-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090339-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2010-09-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090339-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2010-09-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090339-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2010-09-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090339-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2010-09-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090339-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2010-09-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090339-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2010-09-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090339-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2010-09-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090339-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2010-09-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090339-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2010-09-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090339-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2010-09-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090339-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2010-09-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090339-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2010-09-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090339-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2010-09-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090339-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2010-09-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090339-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2010-09-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090339-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2010-09-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090339-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2010-09-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090339-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2010-09-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090339-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2010-09-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090339-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2010-09-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090339-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2010-09-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090339-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2010-09-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090339-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2010-09-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090339-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2010-09-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090339-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2010-09-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A090339-001 AMPICILLIN AND SULBACTAM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE / INJECTION AP 2010-09-20 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Ampicillin and Sulbactam
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMPICILLIN SODIUM 100 mg/mL SULBACTAM SODIUM 50 mg/mL
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 55150-118-99 Ampicillin and Sulbactam 1 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 1 14 55150-118-99 Ampicillin and Sulbactam 100 mL in 1 VIAL, PHARMACY BULK PACKAGE INJECTION, POWDER, FOR SOLUTION 100 14 55150-118-01 Ampicillin and Sulbactam 1 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 1 3 55150-118-01 Ampicillin and Sulbactam 100 mL in 1 VIAL, PHARMACY BULK PACKAGE INJECTION, POWDER, FOR SOLUTION 100 3
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 [AUROMEDICS PHARMA LLC] 4 SULBACTAM SODIUM ACTIVE INGREDIENT DKQ4T82YE6 AMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [AUROMEDICS PHARMA LLC] 4 AMPICILLIN ACTIVE MOIETY 7C782967RD AMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [AUROMEDICS PHARMA LLC] 4 SULBACTAM ACTIVE MOIETY S4TF6I2330 AMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [AUROMEDICS PHARMA LLC] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55150-118 AMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [EUGIA US LLC] 13 Current NDC, Legacy NDC, 2 package rows 20240608_2709e9fc-2341-4382-af72-c2e3201bd77a.zip 55150-118 AMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [EUGIA US LLC] 1 Current NDC, Legacy NDC, 2 package rows 20230414_437a26f4-776b-4f74-99b2-09ad79831b0c.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 Marketing start Marketing end Sample Exclude flag Status 55150-118-01 55150011801 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-118-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE 2012-02-10 No No Current 55150-118-99 55150011899 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-118-99) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE 2012-02-10 0000-00-00 No No Current