FDA.reportPublic FDA data

Naproxen

Product NDC
70954-928
11-digit product format
709540928
Labeler code
70954
Product ID
70954-928_5c522cd1-1631-4254-ae44-cef65573b29f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA218497
Marketing category
ANDA
Marketing start
2024-06-13
Substance
NAPROXEN
Active strength
500 mg/1
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

Additional Listing Data#

Finished product
Yes
Brand name base
Naproxen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57Y76R9ATQ
Rxcui311915, 603103

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fef6ad89-235f-4274-ba49-a8e53642473eProduct name220250225
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
87fed3e6-8fba-48ef-96b0-3a7fb54b96ffProduct name320230306
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8Product name120200623
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
6f4f4521-fd56-1ae6-888b-3b021bd75c7cProduct name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70954-928-10Naproxen100 in 1 BOTTLETABLET, DELAYED RELEASE1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70954-928-10EA - Each70954-92871c99840-de4b-41a8-b1d7-6e2aaff9002c12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70954-928NAPROXEN TABLET, DELAYED RELEASE [ANI PHARMACEUTICALS, INC.]2Current NDC, 1 package rows20250410_052e6fe3-d619-42c3-b64e-67c7aaf7271c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
603103naproxen 375 MG Delayed Release Oral TabletPSN052e6fe3-d619-42c3-b64e-67c7aaf7271c2
311915naproxen 500 MG Delayed Release Oral TabletPSN052e6fe3-d619-42c3-b64e-67c7aaf7271c2
603103naproxen 375 MG Delayed Release Oral TabletSCD052e6fe3-d619-42c3-b64e-67c7aaf7271c2
311915naproxen 500 MG Delayed Release Oral TabletSCD052e6fe3-d619-42c3-b64e-67c7aaf7271c2
311915naproxen (as naproxen sodium) 500 MG Delayed Release Oral TabletSY052e6fe3-d619-42c3-b64e-67c7aaf7271c2
603103naproxen 375 MG (as naproxen sodium 413 MG) Delayed Release Oral TabletSY052e6fe3-d619-42c3-b64e-67c7aaf7271c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70954-928-1070954092810100 TABLET, DELAYED RELEASE in 1 BOTTLE (70954-928-10) 2024-06-13NoNoHistorical