FDA.reportPublic FDA data

Naproxen

Product NDC
66267-153
11-digit product format
662670153
Labeler code
66267
Product ID
66267-153_1f98cfb6-fa4d-2288-e063-6294a90a4de7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA078250
Marketing category
ANDA
Marketing start
2007-07-01
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
Rxcui198014

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
66267-153-102024-08-13C16284748780-1f386c649-d648-0266-e053-dadaa90a7c1aNAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
66267-153-142024-08-13C16284748780-1f386c649-d648-0266-e053-dadaa90a7c1aNAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
66267-153-152024-08-13C16284748780-1f386c649-d648-0266-e053-dadaa90a7c1aNAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
66267-153-202024-08-13C16284748780-1f386c649-d648-0266-e053-dadaa90a7c1aNAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
66267-153-302024-08-13C16284748780-1f386c649-d648-0266-e053-dadaa90a7c1aNAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
66267-153-402024-08-13C16284748780-1f386c649-d648-0266-e053-dadaa90a7c1aNAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
66267-153-422024-08-13C16284748780-1f386c649-d648-0266-e053-dadaa90a7c1aNAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
66267-153-602024-08-13C16284748780-1f386c649-d648-0266-e053-dadaa90a7c1aNAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
66267-153-902024-08-13C16284748780-1f386c649-d648-0266-e053-dadaa90a7c1aNAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
66267-153-102023-01-30C16284748780-1f386c649-d648-0266-e053-dadaa90a7c1aNAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
66267-153-142023-01-30C16284748780-1f386c649-d648-0266-e053-dadaa90a7c1aNAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
66267-153-152023-01-30C16284748780-1f386c649-d648-0266-e053-dadaa90a7c1aNAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
66267-153-202023-01-30C16284748780-1f386c649-d648-0266-e053-dadaa90a7c1aNAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
66267-153-302023-01-30C16284748780-1f386c649-d648-0266-e053-dadaa90a7c1aNAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
66267-153-402023-01-30C16284748780-1f386c649-d648-0266-e053-dadaa90a7c1aNAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
66267-153-422023-01-30C16284748780-1f386c649-d648-0266-e053-dadaa90a7c1aNAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
66267-153-602023-01-30C16284748780-1f386c649-d648-0266-e053-dadaa90a7c1aNAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP
66267-153-902023-01-30C16284748780-1f386c649-d648-0266-e053-dadaa90a7c1aNAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66267-153-10Naproxen10 in 1 BOTTLETABLET105
66267-153-14Naproxen14 in 1 BOTTLETABLET145
66267-153-15Naproxen15 in 1 BOTTLETABLET155
66267-153-20Naproxen20 in 1 BOTTLETABLET205
66267-153-30Naproxen30 in 1 BOTTLETABLET305
66267-153-40Naproxen40 in 1 BOTTLETABLET405
66267-153-42Naproxen42 in 1 BOTTLETABLET425
66267-153-60Naproxen60 in 1 BOTTLETABLET605
66267-153-90Naproxen90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66267-153-10EA - Each66267-153e1b54eb1-cc6f-4eef-832b-402dee6ae72012016-11-08
66267-153-14EA - Each66267-15345260482-ba3c-4007-b9c1-6e2e78c8656f12016-11-08
66267-153-15EA - Each66267-153dcf43333-4700-44bb-b069-2f77b7cb375b12016-11-08
66267-153-20EA - Each66267-1532f5e2585-7984-41d9-86c8-e8955355c92812016-11-08
66267-153-30EA - Each66267-153f73ad854-725b-43c6-a708-92415c90bed212016-11-08
66267-153-40EA - Each66267-153baeae0cb-52b2-4e5f-ae70-455f23cb7d8912016-11-08
66267-153-42EA - Each66267-1535bd91c31-eadc-417d-9633-7dd73104478412016-11-08
66267-153-60EA - Each66267-15317fdbbb7-8d7c-4377-800c-a4fdc5e6c66c12016-11-08
66267-153-90EA - Each66267-153f3dc0cd9-38a2-4a32-adbd-d0f1fc7955b412016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66267-153NAPROXEN TABLET [NUCARE PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 9 package rows20240815_3e8bcc59-dab1-1b4c-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198014naproxen 500 MG Oral TabletPSN3e8bcc59-dab1-1b4c-e054-00144ff88e885
198014naproxen 500 MG Oral TabletSCD3e8bcc59-dab1-1b4c-e054-00144ff88e885

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66267-153-106626701531010 TABLET in 1 BOTTLE (66267-153-10) 10 tablet2016-10-100000-00-00NoNoCurrent
66267-153-146626701531414 TABLET in 1 BOTTLE (66267-153-14) 14 tablet2016-10-100000-00-00NoNoCurrent
66267-153-156626701531515 TABLET in 1 BOTTLE (66267-153-15) 15 tablet2016-10-100000-00-00NoNoCurrent
66267-153-206626701532020 TABLET in 1 BOTTLE (66267-153-20) 20 tablet2016-10-100000-00-00NoNoCurrent
66267-153-306626701533030 TABLET in 1 BOTTLE (66267-153-30) 30 tablet2016-10-100000-00-00NoNoCurrent
66267-153-406626701534040 TABLET in 1 BOTTLE (66267-153-40) 40 tablet2016-10-100000-00-00NoNoCurrent
66267-153-426626701534242 TABLET in 1 BOTTLE (66267-153-42) 42 tablet2016-10-100000-00-00NoNoCurrent
66267-153-606626701536060 TABLET in 1 BOTTLE (66267-153-60) 60 tablet2016-10-100000-00-00NoNoCurrent
66267-153-906626701539090 TABLET in 1 BOTTLE (66267-153-90) 90 tablet2016-10-100000-00-00NoNoCurrent