Home NDC 43063-820 Amoxicillin
Product NDC 43063-820
11-digit product format 430630820
Labeler code 43063
Product ID 43063-820_415ba882-4d6f-3d31-e063-6394a90a3858
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amoxicillin
Dosage form CAPSULE
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA065271
Marketing category ANDA
Marketing start 2005-11-09
Substance AMOXICILLIN
Active strength 500 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 500 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 43063-820-04 Amoxicillin 4 in 1 BOTTLE, PLASTIC CAPSULE 4 35 43063-820-06 Amoxicillin 6 in 1 BOTTLE, PLASTIC CAPSULE 6 35 43063-820-08 Amoxicillin 8 in 1 BOTTLE, PLASTIC CAPSULE 8 35 43063-820-14 Amoxicillin 14 in 1 BOTTLE, PLASTIC CAPSULE 14 35 43063-820-15 Amoxicillin 15 in 1 BOTTLE, PLASTIC CAPSULE 15 35 43063-820-20 Amoxicillin 20 in 1 BOTTLE, PLASTIC CAPSULE 20 35 43063-820-21 Amoxicillin 21 in 1 BOTTLE, PLASTIC CAPSULE 21 35 43063-820-28 Amoxicillin 28 in 1 BOTTLE, PLASTIC CAPSULE 28 35 43063-820-30 Amoxicillin 30 in 1 BOTTLE, PLASTIC CAPSULE 30 35 43063-820-40 Amoxicillin 40 in 1 BOTTLE, PLASTIC CAPSULE 40 35 43063-820-50 Amoxicillin 50 in 1 BOTTLE, PLASTIC CAPSULE 50 35 43063-820-56 Amoxicillin 56 in 1 BOTTLE, PLASTIC CAPSULE 56 35
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43063-820 AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] 34 Current NDC, Legacy NDC, 12 package rows 20240703_d0938df9-9065-47eb-9eae-0722ed1411a1.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 43063-820-04 43063082004 4 CAPSULE in 1 BOTTLE, PLASTIC (43063-820-04) 4 capsule 2019-03-01 0000-00-00 No No Current 43063-820-06 43063082006 6 CAPSULE in 1 BOTTLE, PLASTIC (43063-820-06) 6 capsule 2018-03-09 0000-00-00 No No Current 43063-820-08 43063082008 8 CAPSULE in 1 BOTTLE, PLASTIC (43063-820-08) 8 capsule 2018-09-12 0000-00-00 No No Current 43063-820-14 43063082014 14 CAPSULE in 1 BOTTLE, PLASTIC (43063-820-14) 14 capsule 2018-05-18 0000-00-00 No No Current 43063-820-15 43063082015 15 CAPSULE in 1 BOTTLE, PLASTIC (43063-820-15) 15 capsule 2017-01-05 0000-00-00 No No Current 43063-820-20 43063082020 20 CAPSULE in 1 BOTTLE, PLASTIC (43063-820-20) 20 capsule 2020-12-02 0000-00-00 No No Current 43063-820-21 43063082021 21 CAPSULE in 1 BOTTLE, PLASTIC (43063-820-21) 21 capsule 2018-02-15 0000-00-00 No No Current 43063-820-28 43063082028 28 CAPSULE in 1 BOTTLE, PLASTIC (43063-820-28) 28 capsule 2018-02-26 0000-00-00 No No Current 43063-820-30 43063082030 30 CAPSULE in 1 BOTTLE, PLASTIC (43063-820-30) 30 capsule 2018-04-03 0000-00-00 No No Current 43063-820-40 43063082040 40 CAPSULE in 1 BOTTLE, PLASTIC (43063-820-40) 40 capsule 2018-04-03 0000-00-00 No No Current 43063-820-50 43063082050 50 CAPSULE in 1 BOTTLE, PLASTIC (43063-820-50) 50 capsule 2021-07-06 0000-00-00 No No Current 43063-820-56 43063082056 56 CAPSULE in 1 BOTTLE, PLASTIC (43063-820-56) 56 capsule 2018-02-26 0000-00-00 No No Current