Home NDC 65862-014 Amoxicillin
Product NDC 65862-014
11-digit product format 658620014
Labeler code 65862
Product ID 65862-014_ee0e12cd-e881-4048-a0fb-74bd771cb9aa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amoxicillin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA065256
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 NDC auxiliary status# These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
Current NDC status page 1 of 1 · 3 matching rows.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date unfinished product product 65862-014 UNFINISHED Active or certified unfinished drug listing 2026-10-05 unfinished package package 65862-014 65862-014-22 UNFINISHED Active or certified unfinished drug listing 2026-10-05 unfinished package package 65862-014 65862-014-31 UNFINISHED Active or certified unfinished drug listing 2026-10-05
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 2 · 63 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A065256-001 AMOXICILLIN AMOXICILLIN 500MG TABLET / ORAL AB 2005-11-09 A065256-002 AMOXICILLIN AMOXICILLIN 875MG TABLET / 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 A065256-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-11-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A065256-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-11-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A065256-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-11-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065256-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-11-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065256-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-11-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065256-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-11-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065256-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-11-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065256-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-11-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065256-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-11-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065256-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-11-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065256-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-11-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065256-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-11-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065256-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-11-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065256-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-11-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065256-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-11-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065256-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-11-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065256-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-11-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065256-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-11-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065256-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-11-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065256-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-11-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065256-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-11-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065256-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-11-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065256-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-11-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065256-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-11-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065256-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-11-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065256-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-11-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065256-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-11-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065256-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-11-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065256-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-11-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065256-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-11-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065256-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-11-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065256-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-11-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065256-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-11-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065256-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-11-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065256-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-11-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065256-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-11-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065256-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-11-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065256-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-11-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065256-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-11-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065256-002 AMOXICILLIN 875MG TABLET / 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308192 Internal RxNorm lookup 308194 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 65862-014-01 Amoxicillin 100 in 1 BOTTLE TABLET, FILM COATED 100 17 65862-014-05 Amoxicillin 500 in 1 BOTTLE TABLET, FILM COATED 500 17 65862-014-20 Amoxicillin 20 in 1 BOTTLE TABLET, FILM COATED 20 17
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AMOXICILLIN ACTIVE INGREDIENT 804826J2HU AMOXICILLIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 8 AMOXICILLIN ANHYDROUS ACTIVE MOIETY 9EM05410Q9 AMOXICILLIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 8 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U AMOXICILLIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 8 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK AMOXICILLIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 8 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B AMOXICILLIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 8 HYPROMELLOSE 2910 (15 MPA.S) INACTIVE INGREDIENT 36SFW2JZ0W AMOXICILLIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 8 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 AMOXICILLIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AMOXICILLIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 8 POLYETHYLENE GLYCOL 3350 INACTIVE INGREDIENT G2M7P15E5P AMOXICILLIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 8 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B AMOXICILLIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 8 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 AMOXICILLIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 8 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 AMOXICILLIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 8 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP AMOXICILLIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-014 AMOXICILLIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 17 Current NDC, Legacy NDC, 3 package rows 20240613_99103779-6d2f-4e4b-9b7f-0b24d7c6bf4e.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 2 of 2 · 24 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 65862-014-01 65862001401 100 TABLET, FILM COATED in 1 BOTTLE (65862-014-01) 2005-11-09 0000-00-00 No No Current 65862-014-05 65862001405 500 TABLET, FILM COATED in 1 BOTTLE (65862-014-05) 2005-11-09 0000-00-00 No No Current 65862-014-20 65862001420 20 TABLET, FILM COATED in 1 BOTTLE (65862-014-20) 2005-11-09 0000-00-00 No No Current 65862-014-22 65862001422 2000 TABLET, FILM COATED in 1 BAG (65862-014-22) 09-NOV-05 Current 65862-014-31 65862001431 1700 TABLET, FILM COATED in 1 BAG (65862-014-31) 09-NOV-05 Current