Home NDC 62135-815 Amoxicillin
Product NDC 62135-815
11-digit product format 621350815
Labeler code 62135
Product ID 62135-815_4690e611-3a29-35ce-e063-6294a90a5e9e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amoxicillin
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Chartwell RX, LLC
Application ANDA065319
Marketing category ANDA
Marketing start 2007-06-18
Substance AMOXICILLIN
Active strength 400 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 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065319-002 AMOXICILLIN AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB 2007-06-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065319-002 AB
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 2 · 43 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 A065319-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB 2007-06-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 A065319-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB 2007-06-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065319-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB 2007-06-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065319-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB 2007-06-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065319-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB 2007-06-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065319-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB 2007-06-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065319-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB 2007-06-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065319-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB 2007-06-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065319-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB 2007-06-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065319-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB 2007-06-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065319-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB 2007-06-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065319-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB 2007-06-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065319-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB 2007-06-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065319-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB 2007-06-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065319-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB 2007-06-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065319-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB 2007-06-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065319-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB 2007-06-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065319-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB 2007-06-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065319-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB 2007-06-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065319-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB 2007-06-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065319-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB 2007-06-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065319-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB 2007-06-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065319-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB 2007-06-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065319-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB 2007-06-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065319-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB 2007-06-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065319-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB 2007-06-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065319-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB 2007-06-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065319-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB 2007-06-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065319-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB 2007-06-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065319-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB 2007-06-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065319-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB 2007-06-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065319-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB 2007-06-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065319-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB 2007-06-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065319-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB 2007-06-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065319-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB 2007-06-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065319-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB 2007-06-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065319-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB 2007-06-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065319-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB 2007-06-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065319-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB 2007-06-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065319-002 AMOXICILLIN 400MG/5ML FOR SUSPENSION / ORAL AB 2007-06-18 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 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 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 62135-815-42 Amoxicillin 100 mL in 1 BOTTLE POWDER, FOR SUSPENSION 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-815 AMOXICILLIN POWDER, FOR SUSPENSION [CHARTWELL RX, LLC] 1 Current NDC, 1 package rows 20240630_1b9c0a98-2a31-4b23-ac4f-7c3f14b6f92f.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 62135-815-42 62135081542 100 mL in 1 BOTTLE (62135-815-42) 100 ml 2024-06-25 No No Current