Home NDC 62135-777-38 AMOXICILLIN
Product NDC 62135-777
Requested package NDC 62135-777-38
11-digit product format 621350777
Labeler code 62135
Product ID 62135-777_4690a5fd-79cc-e1fd-e063-6294a90a009c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amoxicillin
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Chartwell RX, LLC
Application ANDA062059
Marketing category ANDA
Marketing start 1978-12-08
Substance AMOXICILLIN
Active strength 250 mg/5mL
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 1 .
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 A062059-001 AMOXICILLIN AMOXICILLIN 125MG/5ML FOR SUSPENSION / ORAL Approved before 1982 A062059-002 AMOXICILLIN AMOXICILLIN 250MG/5ML FOR SUSPENSION / ORAL Approved before 1982
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 · 82 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 2026-02-19 14:30 UTC 2026-02 A062059-001 AMOXICILLIN 125MG/5ML FOR SUSPENSION / ORAL Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A062059-002 AMOXICILLIN 250MG/5ML FOR SUSPENSION / ORAL Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062059-001 AMOXICILLIN 125MG/5ML FOR SUSPENSION / ORAL Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062059-002 AMOXICILLIN 250MG/5ML FOR SUSPENSION / ORAL Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A062059-001 AMOXICILLIN 125MG/5ML FOR SUSPENSION / ORAL Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A062059-002 AMOXICILLIN 250MG/5ML FOR SUSPENSION / ORAL Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062059-001 AMOXICILLIN 125MG/5ML FOR SUSPENSION / ORAL Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062059-002 AMOXICILLIN 250MG/5ML FOR SUSPENSION / ORAL Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062059-001 AMOXICILLIN 125MG/5ML FOR SUSPENSION / ORAL Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062059-002 AMOXICILLIN 250MG/5ML FOR SUSPENSION / ORAL Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062059-001 AMOXICILLIN 125MG/5ML FOR SUSPENSION / ORAL Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062059-002 AMOXICILLIN 250MG/5ML FOR SUSPENSION / ORAL Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062059-001 AMOXICILLIN 125MG/5ML FOR SUSPENSION / ORAL Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062059-002 AMOXICILLIN 250MG/5ML FOR SUSPENSION / ORAL Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062059-001 AMOXICILLIN 125MG/5ML FOR SUSPENSION / ORAL Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062059-002 AMOXICILLIN 250MG/5ML FOR SUSPENSION / ORAL Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062059-001 AMOXICILLIN 125MG/5ML FOR SUSPENSION / ORAL Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062059-002 AMOXICILLIN 250MG/5ML FOR SUSPENSION / ORAL Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A062059-001 AMOXICILLIN 125MG/5ML FOR SUSPENSION / ORAL Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A062059-002 AMOXICILLIN 250MG/5ML FOR SUSPENSION / ORAL Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062059-001 AMOXICILLIN 125MG/5ML FOR SUSPENSION / ORAL Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062059-002 AMOXICILLIN 250MG/5ML FOR SUSPENSION / ORAL Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062059-001 AMOXICILLIN 125MG/5ML FOR SUSPENSION / ORAL Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062059-002 AMOXICILLIN 250MG/5ML FOR SUSPENSION / ORAL Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062059-001 AMOXICILLIN 125MG/5ML FOR SUSPENSION / ORAL Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062059-002 AMOXICILLIN 250MG/5ML FOR SUSPENSION / ORAL Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A062059-001 AMOXICILLIN 125MG/5ML FOR SUSPENSION / ORAL Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A062059-002 AMOXICILLIN 250MG/5ML FOR SUSPENSION / ORAL Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062059-001 AMOXICILLIN 125MG/5ML FOR SUSPENSION / ORAL Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062059-002 AMOXICILLIN 250MG/5ML FOR SUSPENSION / ORAL Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A062059-001 AMOXICILLIN 125MG/5ML FOR SUSPENSION / ORAL Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A062059-002 AMOXICILLIN 250MG/5ML FOR SUSPENSION / ORAL Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A062059-001 AMOXICILLIN 125MG/5ML FOR SUSPENSION / ORAL Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A062059-002 AMOXICILLIN 250MG/5ML FOR SUSPENSION / ORAL Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A062059-001 AMOXICILLIN 125MG/5ML FOR SUSPENSION / ORAL Approved before 1982 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A062059-002 AMOXICILLIN 250MG/5ML FOR SUSPENSION / ORAL Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A062059-001 AMOXICILLIN 125MG/5ML FOR SUSPENSION / ORAL Approved before 1982 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A062059-002 AMOXICILLIN 250MG/5ML FOR SUSPENSION / ORAL Approved before 1982 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A062059-001 AMOXICILLIN 125MG/5ML FOR SUSPENSION / ORAL Approved before 1982 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A062059-002 AMOXICILLIN 250MG/5ML FOR SUSPENSION / ORAL Approved before 1982 782e0a99824c…
Additional Listing Data#
Finished product Yes
Brand name base AMOXICILLIN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMOXICILLIN 250 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 239191 Internal RxNorm lookup 313797 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 62135-777-38 AMOXICILLIN 150 mL in 1 BOTTLE POWDER, FOR SUSPENSION 150 2 62135-777-42 AMOXICILLIN 100 mL in 1 BOTTLE POWDER, FOR SUSPENSION 100 2 62135-777-68 AMOXICILLIN 80 mL in 1 BOTTLE POWDER, FOR SUSPENSION 80 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-777 AMOXICILLIN POWDER, FOR SUSPENSION [CHARTWELL RX, LLC] 1 Current NDC, 3 package rows 20240104_9ce26893-c7a1-47e9-98f9-f5d998cac418.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 · 1 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 62135-777-38 62135077738 150 mL in 1 BOTTLE (62135-777-38) 150 ml 2023-12-15 No No Current