Home NDC 57237-030-01 Amoxicillin
Product NDC 57237-030
Requested package NDC 57237-030-01
11-digit product format 572370030
Labeler code 57237
Product ID 57237-030_4e6f21c7-0e2a-4361-9549-ab42efd08d5b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amoxicillin
Dosage form CAPSULE
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA065271
Marketing category ANDA
Marketing start 2005-11-09
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 43 .
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 A065271-001 AMOXICILLIN AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 A065271-002 AMOXICILLIN AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09
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 3 · 86 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 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065271-001 AMOXICILLIN 250MG CAPSULE / ORAL AB 2005-11-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065271-002 AMOXICILLIN 500MG CAPSULE / ORAL AB 2005-11-09 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 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 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 57237-030-01 Amoxicillin 100 in 1 BOTTLE CAPSULE 100 9 57237-030-05 Amoxicillin 500 in 1 BOTTLE CAPSULE 500 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AMOXICILLIN ACTIVE INGREDIENT 804826J2HU AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 AMOXICILLIN ANHYDROUS ACTIVE MOIETY 9EM05410Q9 AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 GELATIN INACTIVE INGREDIENT 2G86QN327L AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] 7 AMOXICILLIN ACTIVE INGREDIENT 804826J2HU AMOXICILLIN CAPSULE [CITRON PHARMA LLC] 1 AMOXICILLIN ANHYDROUS ACTIVE MOIETY 9EM05410Q9 AMOXICILLIN CAPSULE [CITRON PHARMA LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U AMOXICILLIN CAPSULE [CITRON PHARMA LLC] 1 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH AMOXICILLIN CAPSULE [CITRON PHARMA LLC] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD AMOXICILLIN CAPSULE [CITRON PHARMA LLC] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA AMOXICILLIN CAPSULE [CITRON PHARMA LLC] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L AMOXICILLIN CAPSULE [CITRON PHARMA LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AMOXICILLIN CAPSULE [CITRON PHARMA LLC] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J AMOXICILLIN CAPSULE [CITRON PHARMA LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP AMOXICILLIN CAPSULE [CITRON PHARMA LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57237-030 AMOXICILLIN CAPSULE [RISING PHARMA HOLDINGS, INC.] 9 Current NDC, Legacy NDC, 2 package rows 20240306_bbe590a0-4196-4885-b679-cc1833af567f.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 4 of 4 · 63 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 57237-030-01 57237003001 100 CAPSULE in 1 BOTTLE (57237-030-01) 100 capsule 2005-11-09 0000-00-00 No No Current