Home NDC 65219-020 Ampicillin
Product NDC 65219-020
11-digit product format 652190020
Labeler code 65219
Product ID 65219-020_38c6c088-e4ab-4859-b4d9-89e846cf9d5f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ampicillin sodium
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA062797
Marketing category ANDA
Marketing start 2019-10-31
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 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 A062797-001 AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE / INJECTION 1993-07-12 A062797-002 AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 1993-07-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A062797-002 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 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 A062797-001 AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE / INJECTION 1993-07-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A062797-002 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 1993-07-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A062797-001 AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE / INJECTION 1993-07-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A062797-002 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 1993-07-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062797-001 AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE / INJECTION 1993-07-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062797-002 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 1993-07-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A062797-001 AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE / INJECTION 1993-07-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A062797-002 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 1993-07-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062797-001 AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE / INJECTION 1993-07-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062797-002 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 1993-07-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062797-001 AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE / INJECTION 1993-07-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062797-002 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 1993-07-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062797-001 AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE / INJECTION 1993-07-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062797-002 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 1993-07-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062797-001 AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE / INJECTION 1993-07-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062797-002 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 1993-07-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062797-001 AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE / INJECTION 1993-07-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062797-002 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 1993-07-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062797-001 AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE / INJECTION 1993-07-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062797-002 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 1993-07-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A062797-001 AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE / INJECTION 1993-07-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A062797-002 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 1993-07-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062797-001 AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE / INJECTION 1993-07-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062797-002 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 1993-07-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062797-001 AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE / INJECTION 1993-07-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062797-002 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 1993-07-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062797-001 AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE / INJECTION 1993-07-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062797-002 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 1993-07-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A062797-001 AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE / INJECTION 1993-07-12 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A062797-002 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 1993-07-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062797-001 AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE / INJECTION 1993-07-12 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062797-002 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 1993-07-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A062797-001 AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE / INJECTION 1993-07-12 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A062797-002 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 1993-07-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A062797-001 AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE / INJECTION 1993-07-12 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A062797-002 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 1993-07-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A062797-001 AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE / INJECTION 1993-07-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A062797-002 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 1993-07-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A062797-001 AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE / INJECTION 1993-07-12 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A062797-002 AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION AP 1993-07-12 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1721473 Internal RxNorm lookup 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 65219-020-03 Ampicillin 1 in 1 VIAL INJECTION, POWDER, FOR SOLUTION 1 7 65219-020-23 Ampicillin 10 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 10 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65219-020 AMPICILLIN (AMPICILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC] 7 Current NDC, Legacy NDC, 2 package rows 20221027_8dbb4c71-8543-08f1-e053-2995a90af88d.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 65219-020-03 65219002003 1 in 1 VIAL Historical 65219-020-23 65219002023 10 VIAL in 1 CARTON (65219-020-23) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (65219-020-03) 10 vial 2019-10-31 0000-00-00 No No Current