Home NDC 42708-112 Amoxicillin
Product NDC 42708-112
11-digit product format 427080112
Labeler code 42708
Product ID 42708-112_4682c86c-a853-ade0-e063-6394a90acbce
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amoxicillin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler QPharma, Inc.
Application ANDA065056
Marketing category ANDA
Marketing start 2000-09-26
Substance AMOXICILLIN
Active strength 875 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 A065056-001 AMOXICILLIN AMOXICILLIN 500MG TABLET / ORAL AB 2000-09-18 A065056-002 AMOXICILLIN AMOXICILLIN 875MG TABLET / ORAL AB RS 2000-09-18
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 · 84 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 A065056-001 AMOXICILLIN 500MG TABLET / ORAL AB 2000-09-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065056-002 AMOXICILLIN 875MG TABLET / ORAL AB RS 2000-09-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065056-001 AMOXICILLIN 500MG TABLET / ORAL AB 2000-09-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065056-002 AMOXICILLIN 875MG TABLET / ORAL AB RS 2000-09-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065056-001 AMOXICILLIN 500MG TABLET / ORAL AB 2000-09-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065056-002 AMOXICILLIN 875MG TABLET / ORAL AB RS 2000-09-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065056-001 AMOXICILLIN 500MG TABLET / ORAL AB 2000-09-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065056-002 AMOXICILLIN 875MG TABLET / ORAL AB RS 2000-09-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065056-001 AMOXICILLIN 500MG TABLET / ORAL AB 2000-09-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065056-002 AMOXICILLIN 875MG TABLET / ORAL AB RS 2000-09-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065056-001 AMOXICILLIN 500MG TABLET / ORAL AB 2000-09-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065056-002 AMOXICILLIN 875MG TABLET / ORAL AB RS 2000-09-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065056-001 AMOXICILLIN 500MG TABLET / ORAL AB 2000-09-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065056-002 AMOXICILLIN 875MG TABLET / ORAL AB RS 2000-09-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065056-001 AMOXICILLIN 500MG TABLET / ORAL AB 2000-09-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065056-002 AMOXICILLIN 875MG TABLET / ORAL AB RS 2000-09-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065056-001 AMOXICILLIN 500MG TABLET / ORAL AB 2000-09-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065056-002 AMOXICILLIN 875MG TABLET / ORAL AB RS 2000-09-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065056-001 AMOXICILLIN 500MG TABLET / ORAL AB 2000-09-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065056-002 AMOXICILLIN 875MG TABLET / ORAL AB RS 2000-09-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065056-001 AMOXICILLIN 500MG TABLET / ORAL AB 2000-09-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065056-002 AMOXICILLIN 875MG TABLET / ORAL AB RS 2000-09-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065056-001 AMOXICILLIN 500MG TABLET / ORAL AB 2000-09-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065056-002 AMOXICILLIN 875MG TABLET / ORAL AB RS 2000-09-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065056-001 AMOXICILLIN 500MG TABLET / ORAL AB 2000-09-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065056-002 AMOXICILLIN 875MG TABLET / ORAL AB RS 2000-09-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065056-001 AMOXICILLIN 500MG TABLET / ORAL AB 2000-09-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065056-002 AMOXICILLIN 875MG TABLET / ORAL AB RS 2000-09-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065056-001 AMOXICILLIN 500MG TABLET / ORAL AB 2000-09-18 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065056-002 AMOXICILLIN 875MG TABLET / ORAL AB RS 2000-09-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065056-001 AMOXICILLIN 500MG TABLET / ORAL AB 2000-09-18 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065056-002 AMOXICILLIN 875MG TABLET / ORAL AB RS 2000-09-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065056-001 AMOXICILLIN 500MG TABLET / ORAL AB 2000-09-18 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065056-002 AMOXICILLIN 875MG TABLET / ORAL AB RS 2000-09-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065056-001 AMOXICILLIN 500MG TABLET / ORAL AB 2000-09-18 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065056-002 AMOXICILLIN 875MG TABLET / ORAL AB RS 2000-09-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065056-001 AMOXICILLIN 500MG TABLET / ORAL AB 2000-09-18 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065056-002 AMOXICILLIN 875MG TABLET / ORAL AB RS 2000-09-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065056-001 AMOXICILLIN 500MG TABLET / ORAL AB 2000-09-18 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065056-002 AMOXICILLIN 875MG TABLET / ORAL AB RS 2000-09-18 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 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 875 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 308194 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 42708-112-20 2021-03-15 C162847 48780-1 ba0f9c33-5c52-a910-e053-dadaa90a0b85 These highlights do not include all the information needed to use AMOXICILLIN TABLETS, AMOXICILLIN FOR ORAL SUSPENSION, AMOXICILLIN TABLETS (CHEWABLE), and AMOXICILLIN CAPSULES, safely and effectively. See full prescribing information for AMOXICILLIN TABLETS, AMOXICILLIN FOR ORAL SUSPENSION, AMOXICILLIN TABLETS (CHEWABLE), and AMOXICILLIN CAPSULES. AMOXICILLIN tablets, for oral use AMOXICILLIN for oral suspension, AMOXICILLIN tablets (chewable), for oral use AMOXICILLIN capsules, for oral use Initial U.S. A 42708-112-20 2021-01-29 C162847 48780-1 ba0f9c33-5c52-a910-e053-dadaa90a0b85 These highlights do not include all the information needed to use AMOXICILLIN TABLETS, AMOXICILLIN FOR ORAL SUSPENSION, AMOXICILLIN TABLETS (CHEWABLE), and AMOXICILLIN CAPSULES, safely and effectively. See full prescribing information for AMOXICILLIN TABLETS, AMOXICILLIN FOR ORAL SUSPENSION, AMOXICILLIN TABLETS (CHEWABLE), and AMOXICILLIN CAPSULES. AMOXICILLIN tablets, for oral use AMOXICILLIN for oral suspension, AMOXICILLIN tablets (chewable), for oral use AMOXICILLIN capsules, for oral use Initial U.S. A
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42708-112-20 Amoxicillin 20 in 1 BOTTLE TABLET, FILM COATED 20 31
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42708-112 AMOXICILLIN TABLET, FILM COATED [QPHARMA, INC.] 30 Current NDC, Legacy NDC, 1 package rows 20250523_7f40b439-d826-4a19-b184-702e9bd5a883.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 42708-112-20 42708011220 20 TABLET, FILM COATED in 1 BOTTLE (42708-112-20) 2018-04-17 0000-00-00 Yes No Current