Home NDC 0409-2987 Ampicillin and Sulbactam
Product NDC 0409-2987
11-digit product format 004092987
Labeler code 0409
Product ID 0409-2987_f5c18a44-2ebd-40ba-893b-d6adda64d2b1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ampicillin sodium and Sulbactam sodium
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Hospira, Inc
Application ANDA065310
Marketing category ANDA
Marketing start 2006-07-25
Marketing end 2026-10-31
Substance AMPICILLIN SODIUM; SULBACTAM SODIUM
Active strength 2; 1 g/1; g/1
Pharmacologic classes Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
NDC exclude flag No
Current FDA listing Yes 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 · 24 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 package package 0409-2987-13 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 package package 0409-2987-13 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 package package 0409-2987-13 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 package package 0409-2987-13 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 package package 0409-2987-13 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 package package 0409-2987-13 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 package package 0409-2987-13 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 package package 0409-2987-13 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 package package 0409-2987-13 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 package package 0409-2987-13 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 package package 0409-2987-13 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 package package 0409-2987-13 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A065310-001 AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2006-07-25 A065310-002 AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2006-07-25
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 · 84 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 2026-08-18 06:07:40 2026-07 A065310-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2006-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065310-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2006-07-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065310-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2006-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065310-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2006-07-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065310-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2006-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065310-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2006-07-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065310-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065310-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065310-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065310-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065310-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065310-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065310-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065310-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065310-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065310-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065310-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065310-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065310-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065310-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065310-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065310-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065310-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065310-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065310-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065310-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065310-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065310-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065310-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065310-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065310-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065310-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065310-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065310-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065310-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065310-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065310-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065310-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065310-001 AMPICILLIN AND SULBACTAM EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065310-002 AMPICILLIN AND SULBACTAM EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2006-07-25 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 76 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Ampicillin and Sulbactam Active Ingredients# Ingredient, Strength table Ingredient Strength AMPICILLIN SODIUM 2 g/1 SULBACTAM SODIUM 1 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 0409-2987-03 Ampicillin and Sulbactam 10 in 1 TRAY INJECTION, POWDER, FOR SOLUTION 10 23 0409-2987-23 Ampicillin and Sulbactam 1 in 1 VIAL INJECTION, POWDER, FOR SOLUTION 1 23
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 [HOSPIRA, INC] 11 SULBACTAM SODIUM ACTIVE INGREDIENT DKQ4T82YE6 AMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [HOSPIRA, INC] 11 AMPICILLIN ACTIVE MOIETY 7C782967RD AMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [HOSPIRA, INC] 11 SULBACTAM ACTIVE MOIETY S4TF6I2330 AMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [HOSPIRA, INC] 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-2987 AMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [HOSPIRA, INC] 22 Current NDC, Legacy NDC, 2 package rows 20240828_dc374fa4-350b-425d-a7db-7099fdc64cf1.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0409-2987-03 00409298703 10 VIAL in 1 TRAY (0409-2987-03) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0409-2987-23) 10 vial 2017-09-15 2026-07-31 No No Current 0409-2987-23 00409298723 1 in 1 VIAL Historical