Home NDC 69238-1730 Naproxen
Product NDC 69238-1730
11-digit product format 692381730
Labeler code 69238
Product ID 69238-1730_3b37ffd3-034c-424c-bca0-72f15d719633
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Naproxen
Dosage form SUSPENSION
Route ORAL
Labeler Amneal Pharmaceuticals NY LLC
Application ANDA212705
Marketing category ANDA
Marketing start 2020-08-03
Substance NAPROXEN
Active strength 25 mg/mL
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 69238-1730-2 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 69238-1730-2 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 69238-1730-2 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 69238-1730-2 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 69238-1730-2 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 69238-1730-2 1332a3947898…d4bfe170f9cd…
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 A212705-001 NAPROXEN NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2020-07-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212705-001 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.
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 A212705-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2020-07-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A212705-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2020-07-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212705-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2020-07-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212705-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2020-07-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212705-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2020-07-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212705-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2020-07-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212705-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2020-07-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212705-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2020-07-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212705-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2020-07-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212705-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2020-07-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212705-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2020-07-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212705-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2020-07-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212705-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2020-07-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212705-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2020-07-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212705-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2020-07-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212705-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2020-07-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212705-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2020-07-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212705-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2020-07-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212705-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2020-07-31 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212705-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2020-07-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212705-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2020-07-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212705-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2020-07-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A212705-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2020-07-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A212705-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2020-07-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A212705-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2020-07-31 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212705-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2020-07-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212705-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2020-07-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212705-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2020-07-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212705-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2020-07-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212705-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2020-07-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212705-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2020-07-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212705-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2020-07-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212705-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2020-07-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212705-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2020-07-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212705-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2020-07-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212705-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2020-07-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212705-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2020-07-31 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212705-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2020-07-31 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212705-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2020-07-31 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Naproxen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NAPROXEN 25 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 57Y76R9ATQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311913 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69238-1730-2 Naproxen 473 mL in 1 BOTTLE SUSPENSION 473 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69238-1730 NAPROXEN SUSPENSION [AMNEAL PHARMACEUTICALS NY LLC] 10 Current NDC, Legacy NDC, 1 package rows 20241220_985aedc1-8b3c-4cb4-af13-7203a2b57ab7.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 Marketing end Sample Exclude flag Status 69238-1730-2 69238173002 473 mL in 1 BOTTLE (69238-1730-2) 473 ml 2020-08-03 0000-00-00 No No Current