Home NDC 81964-205 AMOXICILLIN
Product NDC 81964-205
11-digit product format 819640205
Labeler code 81964
Product ID 81964-205_5253eb61-6d82-8057-e063-6294a90a5c84
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amoxicillin
Dosage form CAPSULE
Route ORAL
Labeler USAntibiotics, LLC
Application ANDA062216
Marketing category ANDA
Marketing start 2022-09-15
Substance AMOXICILLIN
Active strength 500 mg/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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A062216-001 AMOXIL AMOXICILLIN 250MG CAPSULE / ORAL AB Approved before 1982 A062216-004 AMOXIL AMOXICILLIN 500MG CAPSULE / ORAL AB Approved before 1982
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 A062216-001 AMOXIL 250MG CAPSULE / ORAL AB Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 A062216-004 AMOXIL 500MG CAPSULE / ORAL AB Approved before 1982 84e616aacf4f…2026-08-18 06:07:40 2026-07 A062216-001 AMOXIL 250MG CAPSULE / ORAL AB Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A062216-004 AMOXIL 500MG CAPSULE / ORAL AB Approved before 1982 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A062216-001 AMOXIL 250MG CAPSULE / ORAL AB Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A062216-004 AMOXIL 500MG CAPSULE / ORAL AB Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062216-001 AMOXIL 250MG CAPSULE / ORAL AB Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062216-004 AMOXIL 500MG CAPSULE / ORAL AB Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A062216-001 AMOXIL 250MG CAPSULE / ORAL AB Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A062216-004 AMOXIL 500MG CAPSULE / ORAL AB Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062216-001 AMOXIL 250MG CAPSULE / ORAL AB Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062216-004 AMOXIL 500MG CAPSULE / ORAL AB Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062216-001 AMOXIL 250MG CAPSULE / ORAL AB Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062216-004 AMOXIL 500MG CAPSULE / ORAL AB Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062216-001 AMOXIL 250MG CAPSULE / ORAL AB Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062216-004 AMOXIL 500MG CAPSULE / ORAL AB Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062216-001 AMOXIL 250MG CAPSULE / ORAL AB Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062216-004 AMOXIL 500MG CAPSULE / ORAL AB Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062216-001 AMOXIL 250MG CAPSULE / ORAL AB Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062216-004 AMOXIL 500MG CAPSULE / ORAL AB Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062216-001 AMOXIL 250MG CAPSULE / ORAL AB Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062216-004 AMOXIL 500MG CAPSULE / ORAL AB Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A062216-001 AMOXIL 250MG CAPSULE / ORAL AB Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A062216-004 AMOXIL 500MG CAPSULE / ORAL AB Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062216-001 AMOXIL 250MG CAPSULE / ORAL AB Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062216-004 AMOXIL 500MG CAPSULE / ORAL AB Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062216-001 AMOXIL 250MG CAPSULE / ORAL AB Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062216-004 AMOXIL 500MG CAPSULE / ORAL AB Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062216-001 AMOXIL 250MG CAPSULE / ORAL AB Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062216-004 AMOXIL 500MG CAPSULE / ORAL AB Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A062216-001 AMOXIL 250MG CAPSULE / ORAL AB Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A062216-004 AMOXIL 500MG CAPSULE / ORAL AB Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062216-001 AMOXIL 250MG CAPSULE / ORAL AB Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062216-004 AMOXIL 500MG CAPSULE / ORAL AB Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A062216-001 AMOXIL 250MG CAPSULE / ORAL AB Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A062216-004 AMOXIL 500MG CAPSULE / ORAL AB Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A062216-001 AMOXIL 250MG CAPSULE / ORAL AB Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A062216-004 AMOXIL 500MG CAPSULE / ORAL AB Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A062216-001 AMOXIL 250MG CAPSULE / ORAL AB Approved before 1982 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A062216-004 AMOXIL 500MG CAPSULE / ORAL AB Approved before 1982 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 2027-12-31 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 · 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 81964-205-01 AMOXICILLIN 100 in 1 BOTTLE CAPSULE 100 5 81964-205-05 AMOXICILLIN 500 in 1 BOTTLE CAPSULE 500 5 81964-205-10 AMOXICILLIN 100 in 1 BOTTLE CAPSULE 100 5 81964-205-60 AMOXICILLIN 60 in 1 BOTTLE CAPSULE 60 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81964-205 AMOXICILLIN CAPSULE [USANTIBIOTICS, LLC] 5 Current NDC, Legacy NDC, 4 package rows 20250528_110ba6b1-f175-48a1-8e30-616c02212538.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 · 4 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 81964-205-01 81964020501 100 CAPSULE in 1 BOTTLE (81964-205-01) 100 capsule 2022-09-15 0000-00-00 No No Current 81964-205-05 81964020505 500 CAPSULE in 1 BOTTLE (81964-205-05) 500 capsule 2022-09-15 0000-00-00 No No Current 81964-205-10 81964020510 100 CAPSULE in 1 BOTTLE (81964-205-10) 100 capsule 2023-03-01 No No Current 81964-205-60 81964020560 60 CAPSULE in 1 BOTTLE (81964-205-60) 60 capsule 2023-03-01 No No Current