Home NDC 59651-550 Ampicillin
Product NDC 59651-550
11-digit product format 596510550
Labeler code 59651
Product ID 59651-550_7aa396aa-691c-4b4d-9363-e977c1e0d44d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ampicillin
Dosage form CAPSULE
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA216554
Marketing category ANDA
Marketing start 2023-10-31
Substance AMPICILLIN TRIHYDRATE
Active strength 250 mg/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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216554-001 AMPICILLIN TRIHYDRATE AMPICILLIN/AMPICILLIN TRIHYDRATE EQ 250MG BASE CAPSULE / ORAL 2023-10-31 A216554-002 AMPICILLIN TRIHYDRATE AMPICILLIN/AMPICILLIN TRIHYDRATE EQ 500MG BASE CAPSULE / ORAL AB 2023-10-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216554-002 AB
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.
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 A216554-001 AMPICILLIN TRIHYDRATE EQ 250MG BASE CAPSULE / ORAL 2023-10-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216554-002 AMPICILLIN TRIHYDRATE EQ 500MG BASE CAPSULE / ORAL AB 2023-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216554-001 AMPICILLIN TRIHYDRATE EQ 250MG BASE CAPSULE / ORAL 2023-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216554-002 AMPICILLIN TRIHYDRATE EQ 500MG BASE CAPSULE / ORAL AB 2023-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216554-001 AMPICILLIN TRIHYDRATE EQ 250MG BASE CAPSULE / ORAL 2023-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216554-002 AMPICILLIN TRIHYDRATE EQ 500MG BASE CAPSULE / ORAL AB 2023-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216554-001 AMPICILLIN TRIHYDRATE EQ 250MG BASE CAPSULE / ORAL 2023-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216554-002 AMPICILLIN TRIHYDRATE EQ 500MG BASE CAPSULE / ORAL AB 2023-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216554-001 AMPICILLIN TRIHYDRATE EQ 250MG BASE CAPSULE / ORAL 2023-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216554-002 AMPICILLIN TRIHYDRATE EQ 500MG BASE CAPSULE / ORAL AB 2023-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216554-001 AMPICILLIN TRIHYDRATE EQ 250MG BASE CAPSULE / ORAL 2023-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216554-002 AMPICILLIN TRIHYDRATE EQ 500MG BASE CAPSULE / ORAL AB 2023-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216554-001 AMPICILLIN TRIHYDRATE EQ 250MG BASE CAPSULE / ORAL 2023-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216554-002 AMPICILLIN TRIHYDRATE EQ 500MG BASE CAPSULE / ORAL AB 2023-10-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216554-001 AMPICILLIN TRIHYDRATE EQ 250MG BASE CAPSULE / ORAL 2023-10-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216554-002 AMPICILLIN TRIHYDRATE EQ 500MG BASE CAPSULE / ORAL AB 2023-10-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216554-001 AMPICILLIN TRIHYDRATE EQ 250MG BASE CAPSULE / ORAL 2023-10-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216554-002 AMPICILLIN TRIHYDRATE EQ 500MG BASE CAPSULE / ORAL AB 2023-10-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216554-001 AMPICILLIN TRIHYDRATE EQ 250MG BASE CAPSULE / ORAL 2023-10-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216554-002 AMPICILLIN TRIHYDRATE EQ 500MG BASE CAPSULE / ORAL AB 2023-10-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216554-001 AMPICILLIN TRIHYDRATE EQ 250MG BASE CAPSULE / ORAL 2023-10-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216554-002 AMPICILLIN TRIHYDRATE EQ 500MG BASE CAPSULE / ORAL AB 2023-10-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216554-001 AMPICILLIN TRIHYDRATE EQ 250MG BASE CAPSULE / ORAL 2023-10-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216554-002 AMPICILLIN TRIHYDRATE EQ 500MG BASE CAPSULE / ORAL AB 2023-10-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216554-001 AMPICILLIN TRIHYDRATE EQ 250MG BASE CAPSULE / ORAL 2023-10-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216554-002 AMPICILLIN TRIHYDRATE EQ 500MG BASE CAPSULE / ORAL AB 2023-10-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216554-001 AMPICILLIN TRIHYDRATE EQ 250MG BASE CAPSULE / ORAL 2023-10-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A216554-002 AMPICILLIN TRIHYDRATE EQ 500MG BASE CAPSULE / ORAL AB 2023-10-31 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216554-001 AMPICILLIN TRIHYDRATE EQ 250MG BASE CAPSULE / ORAL 2023-10-31 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216554-002 AMPICILLIN TRIHYDRATE EQ 500MG BASE CAPSULE / ORAL AB 2023-10-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216554-001 AMPICILLIN TRIHYDRATE EQ 250MG BASE CAPSULE / ORAL 2023-10-31 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A216554-002 AMPICILLIN TRIHYDRATE EQ 500MG BASE CAPSULE / ORAL AB 2023-10-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216554-001 AMPICILLIN TRIHYDRATE EQ 250MG BASE CAPSULE / ORAL 2023-10-31 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A216554-002 AMPICILLIN TRIHYDRATE EQ 500MG BASE CAPSULE / ORAL AB 2023-10-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216554-001 AMPICILLIN TRIHYDRATE EQ 250MG BASE CAPSULE / ORAL 2023-10-31 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216554-002 AMPICILLIN TRIHYDRATE EQ 500MG BASE CAPSULE / ORAL AB 2023-10-31 a72a2bbeb626…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216554-001 AMPICILLIN TRIHYDRATE EQ 250MG BASE CAPSULE / ORAL 2023-10-31 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216554-002 AMPICILLIN TRIHYDRATE EQ 500MG BASE CAPSULE / ORAL AB 2023-10-31 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Ampicillin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMPICILLIN TRIHYDRATE 250 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination HXQ6A1N7R6 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308212 Internal RxNorm lookup 313800 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 59651-550-01 Ampicillin 100 in 1 BOTTLE CAPSULE 100 4 59651-550-05 Ampicillin 500 in 1 BOTTLE CAPSULE 500 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59651-550 AMPICILLIN CAPSULE [AUROBINDO PHARMA LIMITED] 3 Current NDC, 2 package rows 20240208_7f8b1ab1-73c6-4cdf-a838-7a4554c62586.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 · 1 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 59651-550-01 59651055001 100 CAPSULE in 1 BOTTLE (59651-550-01) 100 capsule 2023-10-31 No No Current 59651-550-05 59651055005 500 CAPSULE in 1 BOTTLE (59651-550-05) 500 capsule 2023-10-31 No No Current