Home NDC 0781-5060 Amoxicillin
Product NDC 0781-5060
11-digit product format 007815060
Labeler code 0781
Product ID 0781-5060_f314ad63-2023-476e-a211-f9cef3be8e2c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amoxicillin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sandoz Inc
Application ANDA065228
Marketing category ANDA
Marketing start 2005-07-13
Marketing end 0000-00-00
Substance AMOXICILLIN
Active strength 500 mg/1
Pharmacologic classes Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record 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 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A065228-001 AMOXICILLIN AMOXICILLIN 500MG TABLET / ORAL AB 2005-07-13 A065228-002 AMOXICILLIN AMOXICILLIN 875MG TABLET / ORAL AB 2005-07-13
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 A065228-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-07-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065228-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-07-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065228-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-07-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065228-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-07-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065228-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-07-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065228-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-07-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065228-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-07-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065228-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-07-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065228-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-07-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065228-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-07-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065228-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-07-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065228-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-07-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065228-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-07-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065228-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-07-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065228-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-07-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065228-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-07-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065228-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-07-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065228-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-07-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065228-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-07-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065228-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-07-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065228-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-07-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065228-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-07-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065228-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-07-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065228-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-07-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065228-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-07-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065228-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-07-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065228-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-07-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065228-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-07-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065228-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-07-13 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065228-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-07-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065228-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-07-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065228-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-07-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065228-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-07-13 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065228-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-07-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065228-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-07-13 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065228-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-07-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065228-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-07-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065228-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-07-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065228-001 AMOXICILLIN 500MG TABLET / ORAL AB 2005-07-13 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065228-002 AMOXICILLIN 875MG TABLET / ORAL AB 2005-07-13 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 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 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 239191 Internal RxNorm lookup 308182 Internal RxNorm lookup 308189 Internal RxNorm lookup 308191 Internal RxNorm lookup 308192 Internal RxNorm lookup 308194 Internal RxNorm lookup 313797 Internal RxNorm lookup 313850 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 0781-5060-01 Amoxicillin 100 in 1 BOTTLE TABLET, FILM COATED 100 25 0781-5060-20 Amoxicillin 20 in 1 BOTTLE TABLET, FILM COATED 20 25
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AMOXICILLIN ACTIVE INGREDIENT 804826J2HU AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC] 13 AMOXICILLIN ANHYDROUS ACTIVE MOIETY 9EM05410Q9 AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC] 13 ALCOHOL INACTIVE INGREDIENT 3K9958V90M AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC] 13 AMMONIA INACTIVE INGREDIENT 5138Q19F1X AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC] 13 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC] 13 ANHYDROUS TRISODIUM CITRATE INACTIVE INGREDIENT RS7A450LGA AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC] 13 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC] 13 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC] 13 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC] 13 ETHYLCELLULOSES INACTIVE INGREDIENT 7Z8S9VYZ4B AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC] 13 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC] 13 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC] 13 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC] 13 GELATIN INACTIVE INGREDIENT 2G86QN327L AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC] 13 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC] 13 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC] 13 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC] 13 POTASSIUM HYDROXIDE INACTIVE INGREDIENT WZH3C48M4T AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC] 13 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC] 13 SHELLAC INACTIVE INGREDIENT 46N107B71O AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC] 13 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC] 13 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC] 13 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC] 13 SUCROSE INACTIVE INGREDIENT C151H8M554 AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC] 13 TALC INACTIVE INGREDIENT 7SEV7J4R1U AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC] 13 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC] 13 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC] 13 WATER INACTIVE INGREDIENT 059QF0KO0R AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC] 13 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC] 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0781-5060 AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC] 23 Legacy NDC, 2 package rows 20250116_13bd4214-9b7f-425b-af5f-fc1ddc678230.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 Marketing start Marketing end Sample Exclude flag Status 0781-5060-01 00781506001 100 TABLET, FILM COATED in 1 BOTTLE (0781-5060-01) 2005-07-13 0000-00-00 No No Current 0781-5060-20 00781506020 20 TABLET, FILM COATED in 1 BOTTLE (0781-5060-20) 2005-07-13 0000-00-00 No No Current