Home NDC 25021-137 ampicillin
Product NDC 25021-137
11-digit product format 250210137
Labeler code 25021
Product ID 25021-137_c3bd533d-1831-4030-8fc0-97c93f4803b6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ampicillin
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Sagent Pharmaceuticals
Application ANDA090354
Marketing category ANDA
Marketing start 2014-07-01
Substance AMPICILLIN SODIUM
Active strength 2 g/1
Pharmacologic classes Penicillin-class Antibacterial [EPC], Penicillins [CS]
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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090354-001 AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 A090354-002 AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 A090354-003 AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 A090354-004 AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 5 · 164 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 A090354-001 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090354-002 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090354-003 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090354-004 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090354-001 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090354-002 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090354-003 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090354-004 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090354-001 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090354-002 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090354-003 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090354-004 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090354-001 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090354-002 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090354-003 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090354-004 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090354-001 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090354-002 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090354-003 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090354-004 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090354-001 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090354-002 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090354-003 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090354-004 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090354-001 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090354-002 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090354-003 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090354-004 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090354-001 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090354-002 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090354-003 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090354-004 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090354-001 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090354-002 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090354-003 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090354-004 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090354-001 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090354-002 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090354-003 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090354-004 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 2009-12-28 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
Additional Listing Data#
Finished product Yes
Brand name base ampicillin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMPICILLIN SODIUM 2 g/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination JFN36L5S8K Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1721475 Internal RxNorm lookup 1721476 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 25021-137-20 ampicillin 10 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 10 17 25021-137-20 ampicillin 1 in 1 VIAL INJECTION, POWDER, FOR SOLUTION 1 17
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 25021-137 AMPICILLIN INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS] 17 Current NDC, Legacy NDC, 2 package rows 20240328_9d2aebe8-4f04-49dd-b1e5-80b962868dc3.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 Marketing end Sample Exclude flag Status 25021-137-20 25021013720 10 VIAL in 1 CARTON (25021-137-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL 10 vial 2014-07-01 0000-00-00 No No Current