Home NDC 42571-233 AMOXICILLIN
Product NDC 42571-233
11-digit product format 425710233
Labeler code 42571
Product ID 42571-233_238f9a44-0678-eb7c-e063-6394a90a4c73
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amoxicillin
Dosage form CAPSULE
Route ORAL
Labeler Micro Labs Limited
Application ANDA207471
Marketing category ANDA
Marketing start 2022-11-01
Substance AMOXICILLIN
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 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 A207471-001 AMOXICILLIN AMOXICILLIN 250MG CAPSULE / ORAL AB 2022-06-24 A207471-002 AMOXICILLIN AMOXICILLIN 500MG CAPSULE / ORAL AB 2022-06-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 2 · 58 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 A207471-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2022-06-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207471-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2022-06-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207471-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2022-06-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207471-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2022-06-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207471-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2022-06-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207471-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2022-06-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207471-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2022-06-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207471-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2022-06-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207471-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2022-06-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207471-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2022-06-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207471-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2022-06-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207471-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2022-06-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207471-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2022-06-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207471-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2022-06-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207471-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2022-06-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207471-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2022-06-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207471-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2022-06-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207471-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2022-06-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207471-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2022-06-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207471-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2022-06-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207471-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2022-06-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207471-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2022-06-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207471-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2022-06-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207471-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2022-06-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207471-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2022-06-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207471-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2022-06-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207471-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2022-06-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207471-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2022-06-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207471-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2022-06-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A207471-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2022-06-24 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207471-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2022-06-24 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207471-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2022-06-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207471-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2022-06-24 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A207471-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2022-06-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207471-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2022-06-24 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A207471-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2022-06-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207471-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2022-06-24 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207471-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2022-06-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207471-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2022-06-24 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207471-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2022-06-24 9b2671bbb829…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 58 observed states.
Additional Listing Data#
Finished product Yes
Brand name base AMOXICILLIN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMOXICILLIN 250 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 804826J2HU Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308182 Internal RxNorm lookup 308191 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 42571-233-01 AMOXICILLIN 100 in 1 BOTTLE CAPSULE 100 4 42571-233-05 AMOXICILLIN 500 in 1 BOTTLE CAPSULE 500 4 42571-233-10 AMOXICILLIN 1000 in 1 BOTTLE CAPSULE 1000 4 42571-233-30 AMOXICILLIN 30 in 1 BOTTLE CAPSULE 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42571-233 AMOXICILLIN (AMOXICILLIN) CAPSULE [MICRO LABS LIMITED] 4 Current NDC, Legacy NDC, 4 package rows 20241004_42f935ca-45ba-4b3e-8b40-9b2d4eb56281.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 Marketing end Sample Exclude flag Status 42571-233-01 42571023301 100 CAPSULE in 1 BOTTLE (42571-233-01) 100 capsule 2022-11-01 0000-00-00 No No Current 42571-233-05 42571023305 500 CAPSULE in 1 BOTTLE (42571-233-05) 500 capsule 2022-11-01 0000-00-00 No No Current 42571-233-10 42571023310 1000 CAPSULE in 1 BOTTLE (42571-233-10) 1000 capsule 2022-11-01 0000-00-00 No No Current 42571-233-30 42571023330 30 CAPSULE in 1 BOTTLE (42571-233-30) 30 capsule 2022-11-01 0000-00-00 No No Current