Home NDC 70954-151-10 Naproxen Oral Suspension
Product NDC 70954-151
Requested package NDC 70954-151-10
11-digit product format 709540151
Labeler code 70954
Product ID 70954-151_1aa670cb-8d65-413a-9bdd-680cafd9b5c4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Naproxen oral
Dosage form SUSPENSION
Route ORAL
Labeler ANI Pharmaceuticals, Inc.
Application ANDA211910
Marketing category ANDA
Marketing start 2021-03-12
Substance NAPROXEN
Active strength 125 mg/5mL
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 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 A211910-001 NAPROXEN NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2021-03-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211910-001 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 A211910-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2021-03-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211910-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2021-03-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211910-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2021-03-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211910-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2021-03-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211910-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2021-03-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211910-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2021-03-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211910-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2021-03-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211910-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2021-03-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211910-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2021-03-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211910-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2021-03-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211910-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2021-03-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211910-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2021-03-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211910-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2021-03-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211910-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2021-03-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211910-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2021-03-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211910-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2021-03-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211910-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2021-03-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211910-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2021-03-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211910-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2021-03-10 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A211910-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2021-03-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211910-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2021-03-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211910-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2021-03-10 87673890dc5c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211910-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2021-03-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211910-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2021-03-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211910-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2021-03-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211910-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2021-03-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211910-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2021-03-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211910-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2021-03-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211910-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2021-03-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211910-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2021-03-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211910-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2021-03-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211910-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2021-03-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211910-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2021-03-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211910-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2021-03-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211910-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2021-03-10 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211910-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB 2021-03-10 a50c72e98297…
Observed Orange Book normalized TE history# 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 Naproxen Oral Suspension
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NAPROXEN 125 mg/5mL
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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70954-151-10 Naproxen Oral Suspension 500 mL in 1 BOTTLE SUSPENSION 500 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70954-151 NAPROXEN ORAL SUSPENSION (NAPROXEN ORAL) SUSPENSION [ANI PHARMACEUTICALS, INC.] 3 Current NDC, Legacy NDC, 1 package rows 20250402_252726a7-757a-4b97-b5b8-ffff4ac1d103.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 70954-151-10 70954015110 500 mL in 1 BOTTLE (70954-151-10) 500 ml 2021-03-12 0000-00-00 No No Current