Home NDC 44567-104 Ampicillin
Product NDC 44567-104
11-digit product format 445670104
Labeler code 44567
Product ID 44567-104_0e3ba13c-dfd5-4c47-9c8f-f621d4e93c44
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ampicillin
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler WG Critical Care, LLC
Application ANDA201404
Marketing category ANDA
Marketing start 2012-05-10
Substance AMPICILLIN SODIUM
Active strength 10 g/1
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 43 .
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 · 43 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 2026-09-14 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…2022-10-28 04:53 UTC 2022-10 A201404-001 AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2013-12-20 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMPICILLIN SODIUM 10 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 · 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 44567-104-01 Ampicillin 100 mL in 1 VIAL INJECTION, POWDER, FOR SOLUTION 100 16 44567-104-01 Ampicillin 1 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 1 16 44567-104-10 Ampicillin 100 mL in 1 VIAL INJECTION, POWDER, FOR SOLUTION 100 16 44567-104-10 Ampicillin 10 in 1 TRAY INJECTION, POWDER, FOR SOLUTION 10 16
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 44567-104 AMPICILLIN INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC] 15 Current NDC, Legacy NDC, 4 package rows 20240322_12b6ac82-ca74-4f88-99ea-ae4a1c419b70.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ampicillin Sodium AMPICILLIN SODIUM Sagent Pharmaceuticals 5b3796dd-6f81-4999-ae2b-a13a72795729 2026-07-27 Warnings, Adverse reactions Exact identifier application applno (ANDA): 201404 application number: ANDA201404 Ampicillin AMPICILLIN WG Critical Care, LLC 12b6ac82-ca74-4f88-99ea-ae4a1c419b70 2026-06-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 201404 application number: ANDA201404 ndc (product): 44567-104 Ampicillin AMPICILLIN SODIUM NorthStar Rx, LLC 3b683547-48ac-48ca-8fd4-6866fd17be34 2026-06-15 Warnings, Adverse reactions Exact identifier application applno (ANDA): 201404 application number: ANDA201404 Ampicillin AMPICILLIN SODIUM Avenacy Inc. 19546563-50b7-4160-8cbe-f8e7079cba69 2025-02-01 Warnings, Adverse reactions Exact identifier application applno (ANDA): 201404 application number: ANDA201404 Ampicillin AMPICILLIN SODIUM Athenex Pharmaceutical Division, LLC. 06b1c203-600c-4083-986a-d1d471b56e43 2025-01-28 Warnings, Adverse reactions Exact identifier application applno (ANDA): 201404 application number: ANDA201404
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 44567-104-01 44567010401 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (44567-104-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE 2019-07-03 0000-00-00 No No Current 44567-104-10 44567010410 10 VIAL in 1 TRAY (44567-104-10) > 100 mL in 1 VIAL 10 vial 2012-05-10 0000-00-00 No No Current