FDA.reportPublic FDA data

Naproxen

Product NDC
66267-373
11-digit product format
662670373
Labeler code
66267
Product ID
66267-373_1fa6c8e0-0ee3-12f2-e063-6294a90a8951
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA091432
Marketing category
ANDA
Marketing start
2016-07-05
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fef6ad89-235f-4274-ba49-a8e53642473eProduct name220250225
87fed3e6-8fba-48ef-96b0-3a7fb54b96ffProduct name320230306
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8Product name120200623
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
6f4f4521-fd56-1ae6-888b-3b021bd75c7cProduct name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66267-373-202024-08-14C16284748780-1f386c64a-45cd-0266-e053-dadaa90a7c1aNaproxen Delayed-release Tablets USP, 375 mg and 500 mg Rx only
66267-373-302024-08-14C16284748780-1f386c64a-45cd-0266-e053-dadaa90a7c1aNaproxen Delayed-release Tablets USP, 375 mg and 500 mg Rx only
66267-373-602024-08-14C16284748780-1f386c64a-45cd-0266-e053-dadaa90a7c1aNaproxen Delayed-release Tablets USP, 375 mg and 500 mg Rx only
66267-373-202023-01-30C16284748780-1f386c64a-45cd-0266-e053-dadaa90a7c1aNaproxen Delayed-release Tablets USP, 375 mg and 500 mg Rx only
66267-373-302023-01-30C16284748780-1f386c64a-45cd-0266-e053-dadaa90a7c1aNaproxen Delayed-release Tablets USP, 375 mg and 500 mg Rx only
66267-373-602023-01-30C16284748780-1f386c64a-45cd-0266-e053-dadaa90a7c1aNaproxen Delayed-release Tablets USP, 375 mg and 500 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66267-373-20Naproxen20 in 1 BOTTLETABLET, DELAYED RELEASE204
66267-373-30Naproxen30 in 1 BOTTLETABLET, DELAYED RELEASE304
66267-373-60Naproxen60 in 1 BOTTLETABLET, DELAYED RELEASE604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66267-373-20EA - Each66267-373d601ff1a-1cea-4b1f-8bd5-9f148414ef2912018-01-12
66267-373-60EA - Each66267-373ccce6fe1-f09f-48b5-939c-28aec19d397a12018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66267-373NAPROXEN TABLET, DELAYED RELEASE [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 3 package rows20240815_5e873524-f9fb-fe2d-e053-2991aa0aa0a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311915naproxen 500 MG Delayed Release Oral TabletPSN5e873524-f9fb-fe2d-e053-2991aa0aa0a54
311915naproxen 500 MG Delayed Release Oral TabletSCD5e873524-f9fb-fe2d-e053-2991aa0aa0a54
311915naproxen (as naproxen sodium) 500 MG Delayed Release Oral TabletSY5e873524-f9fb-fe2d-e053-2991aa0aa0a54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
66267-373-206626703732020 TABLET, DELAYED RELEASE in 1 BOTTLE (66267-373-20) 2017-11-210000-00-00NoNoCurrent
66267-373-306626703733030 TABLET, DELAYED RELEASE in 1 BOTTLE (66267-373-30) 2017-11-210000-00-00NoNoCurrent
66267-373-606626703736060 TABLET, DELAYED RELEASE in 1 BOTTLE (66267-373-60) 2017-11-210000-00-00NoNoCurrent