Home NDC 25021-197 Ampicillin Sodium
Product NDC 25021-197
11-digit product format 250210197
Labeler code 25021
Product ID 25021-197_9512d4e6-daf7-4a18-87c0-78ebb825a25d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ampicillin Sodium
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Sagent Pharmaceuticals
Application ANDA201404
Marketing category ANDA
Marketing start 2025-01-15
Substance AMPICILLIN SODIUM
Active strength 10 g/100mL
Pharmacologic classes Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A201404-001 AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2013-12-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A201404-001 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 · 44 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 2026-10-15 13:18:30 2026-09 A201404-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2013-12-20 c2088c7a36db…2026-09-14 22:38:34 2026-08 A201404-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2013-12-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A201404-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2013-12-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A201404-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2013-12-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201404-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2013-12-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201404-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2013-12-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201404-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2013-12-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201404-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2013-12-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201404-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2013-12-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201404-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2013-12-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201404-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2013-12-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201404-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2013-12-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201404-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2013-12-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201404-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2013-12-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201404-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2013-12-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201404-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2013-12-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201404-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2013-12-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201404-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2013-12-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201404-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2013-12-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201404-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2013-12-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201404-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2013-12-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201404-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2013-12-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201404-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2013-12-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A201404-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2013-12-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A201404-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2013-12-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A201404-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2013-12-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A201404-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2013-12-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A201404-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2013-12-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A201404-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2013-12-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A201404-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2013-12-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A201404-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2013-12-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A201404-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2013-12-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A201404-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2013-12-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A201404-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2013-12-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A201404-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2013-12-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A201404-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2013-12-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A201404-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2013-12-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A201404-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2013-12-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A201404-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2013-12-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A201404-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2013-12-20 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Ampicillin Sodium
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMPICILLIN SODIUM 10 g/100mL
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 789980 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 25021-197-99 Ampicillin Sodium 1 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 1 1 25021-197-99 Ampicillin Sodium 100 mL in 1 BOTTLE INJECTION, POWDER, FOR SOLUTION 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 25021-197 AMPICILLIN SODIUM INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS] 1 Current NDC, 2 package rows 20250115_5b3796dd-6f81-4999-ae2b-a13a72795729.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 25021-197-99 25021019799 1 BOTTLE in 1 CARTON (25021-197-99) / 100 mL in 1 BOTTLE 1 bottle 2025-01-15 No No Current