Home NDC 72603-363 Ampicillin
Product NDC 72603-363
11-digit product format 726030363
Labeler code 72603
Product ID 72603-363_ccfb8b44-c373-40a6-8fc9-afd9584e5970
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ampicillin sodium
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler NorthStar Rx, LLC
Application ANDA062719
Marketing category ANDA
Marketing start 2024-03-01
Substance AMPICILLIN SODIUM
Active strength 1 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 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A062719-001 AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 1987-05-12 A062719-002 AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 1987-05-12 A062719-003 AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1987-05-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 126 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 A062719-001 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 1987-05-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A062719-002 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 1987-05-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A062719-003 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1987-05-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A062719-001 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 1987-05-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A062719-002 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 1987-05-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A062719-003 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1987-05-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062719-001 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 1987-05-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062719-002 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 1987-05-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062719-003 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1987-05-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A062719-001 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 1987-05-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A062719-002 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 1987-05-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A062719-003 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1987-05-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062719-001 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 1987-05-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062719-002 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 1987-05-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062719-003 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1987-05-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062719-001 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 1987-05-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062719-002 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 1987-05-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062719-003 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1987-05-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062719-001 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 1987-05-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062719-002 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 1987-05-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062719-003 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1987-05-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062719-001 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 1987-05-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062719-002 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 1987-05-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062719-003 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1987-05-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062719-001 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 1987-05-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062719-002 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 1987-05-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062719-003 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1987-05-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062719-001 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 1987-05-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062719-002 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 1987-05-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062719-003 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1987-05-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A062719-001 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 1987-05-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A062719-002 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 1987-05-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A062719-003 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1987-05-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062719-001 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 1987-05-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062719-002 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 1987-05-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062719-003 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1987-05-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062719-001 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 1987-05-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062719-002 AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 1987-05-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062719-003 AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1987-05-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062719-001 AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE / INJECTION AP 1987-05-12 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Ampicillin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMPICILLIN SODIUM 1 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1721474 Internal RxNorm lookup 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 72603-363-01 Ampicillin 1 in 1 VIAL INJECTION, POWDER, FOR SOLUTION 1 1 72603-363-10 Ampicillin 10 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 10 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72603-363 AMPICILLIN (AMPICILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [NORTHSTAR RX, LLC] 1 Current NDC, 2 package rows 20240301_6772d650-9814-49e4-a4ec-0b1a97b837d1.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join AMPICILLIN AMPICILLIN Civica, Inc. a194f310-a669-4d8f-8c04-ee9ca01939b1 2025-12-09 Warnings, Adverse reactions Exact identifier application applno (ANDA): 062719 application number: ANDA062719 Ampicillin AMPICILLIN SODIUM NorthStar Rx, LLC 6772d650-9814-49e4-a4ec-0b1a97b837d1 2024-02-22 Warnings, Adverse reactions Exact identifier application applno (ANDA): 062719 application number: ANDA062719 ndc (product): 72603-363 AMPICILLIN AMPICILLIN HF Acquisition Co LLC, DBA HealthFirst e47a21b1-bbdb-4321-e053-2a95a90a3b4a 2024-01-28 Warnings, Adverse reactions Exact identifier application applno (ANDA): 062719 application number: ANDA062719 Ampicillin AMPICILLIN SODIUM Fresenius Kabi USA, LLC 8dbb4c71-8543-08f1-e053-2995a90af88d 2022-10-21 Warnings, Adverse reactions Exact identifier application applno (ANDA): 062719 application number: ANDA062719
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72603-363-01 72603036301 1 in 1 VIAL Historical 72603-363-10 72603036310 10 VIAL in 1 CARTON (72603-363-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (72603-363-01) 10 vial 2024-03-01 No No Current