Home NDC 68788-8731 Amoxicillin
Product NDC 68788-8731
11-digit product format 687888731
Labeler code 68788
Product ID 68788-8731_f1194a1f-53b3-46d4-9dc5-112f9e0eb773
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amoxicillin
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Preferred Pharmaceuticals Inc.
Application ANDA065119
Marketing category ANDA
Marketing start 2024-09-16
Substance AMOXICILLIN
Active strength 400 mg/5mL
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 A065119-001 AMOXICILLIN AMOXICILLIN 200MG/5ML FOR SUSPENSION / ORAL AB 2002-12-04 A065119-002 AMOXICILLIN AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB RS 2002-12-04
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 A065119-001 AMOXICILLIN 200MG/5ML FOR SUSPENSION / ORAL AB 2002-12-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A065119-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB RS 2002-12-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 A065119-001 AMOXICILLIN 200MG/5ML FOR SUSPENSION / ORAL AB 2002-12-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065119-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB RS 2002-12-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065119-001 AMOXICILLIN 200MG/5ML FOR SUSPENSION / ORAL AB 2002-12-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065119-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB RS 2002-12-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065119-001 AMOXICILLIN 200MG/5ML FOR SUSPENSION / ORAL AB 2002-12-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065119-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB RS 2002-12-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065119-001 AMOXICILLIN 200MG/5ML FOR SUSPENSION / ORAL AB 2002-12-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065119-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB RS 2002-12-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065119-001 AMOXICILLIN 200MG/5ML FOR SUSPENSION / ORAL AB 2002-12-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065119-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB RS 2002-12-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065119-001 AMOXICILLIN 200MG/5ML FOR SUSPENSION / ORAL AB 2002-12-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065119-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB RS 2002-12-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065119-001 AMOXICILLIN 200MG/5ML FOR SUSPENSION / ORAL AB 2002-12-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065119-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB RS 2002-12-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065119-001 AMOXICILLIN 200MG/5ML FOR SUSPENSION / ORAL AB 2002-12-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065119-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB RS 2002-12-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065119-001 AMOXICILLIN 200MG/5ML FOR SUSPENSION / ORAL AB 2002-12-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065119-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB RS 2002-12-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065119-001 AMOXICILLIN 200MG/5ML FOR SUSPENSION / ORAL AB 2002-12-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065119-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB RS 2002-12-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065119-001 AMOXICILLIN 200MG/5ML FOR SUSPENSION / ORAL AB 2002-12-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065119-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB RS 2002-12-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065119-001 AMOXICILLIN 200MG/5ML FOR SUSPENSION / ORAL AB 2002-12-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065119-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB RS 2002-12-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065119-001 AMOXICILLIN 200MG/5ML FOR SUSPENSION / ORAL AB 2002-12-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065119-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB RS 2002-12-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065119-001 AMOXICILLIN 200MG/5ML FOR SUSPENSION / ORAL AB 2002-12-04 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065119-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB RS 2002-12-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065119-001 AMOXICILLIN 200MG/5ML FOR SUSPENSION / ORAL AB 2002-12-04 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065119-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB RS 2002-12-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065119-001 AMOXICILLIN 200MG/5ML FOR SUSPENSION / ORAL AB 2002-12-04 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065119-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB RS 2002-12-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065119-001 AMOXICILLIN 200MG/5ML FOR SUSPENSION / ORAL AB 2002-12-04 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065119-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB RS 2002-12-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065119-001 AMOXICILLIN 200MG/5ML FOR SUSPENSION / ORAL AB 2002-12-04 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065119-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB RS 2002-12-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065119-001 AMOXICILLIN 200MG/5ML FOR SUSPENSION / ORAL AB 2002-12-04 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065119-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB RS 2002-12-04 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 400 mg/5mL
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 308189 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 68788-8731-1 Amoxicillin 100 mL in 1 BOTTLE POWDER, FOR SUSPENSION 100 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-8731 AMOXICILLIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS INC.] 2 Current NDC, 1 package rows 20250205_8dfbaa75-87ba-4a6b-a2db-176441a842af.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 Sample Exclude flag Status 68788-8731-1 68788873101 100 mL in 1 BOTTLE (68788-8731-1) 100 ml 2024-09-16 No No Current