FDA.reportPublic FDA data

Naproxen

Product NDC
70010-139
11-digit product format
700100139
Labeler code
70010
Product ID
70010-139_451b46b7-e6fb-8436-e063-6294a90adcf1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Granules Pharmaceuticals Inc.
Application
ANDA074140
Marketing category
ANDA
Marketing start
2021-04-15
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
Rxcui198012, 198013, 198014

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70010-139-01Naproxen100 in 1 BOTTLETABLET10011
70010-139-05Naproxen500 in 1 BOTTLETABLET50011
70010-139-10Naproxen1000 in 1 BOTTLETABLET100011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70010-139-01EA - Each70010-139246c276c-d25d-4751-8351-21ff4dd29dc512021-08-05
70010-139-05EA - Each70010-13952eeb27b-cb29-4965-b8da-8d0eb7aeaed012021-08-05
70010-139-10EA - Each70010-139ddf15af8-b3bc-400c-9fe0-96240f223e2612021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-139NAPROXEN TABLET [GRANULES PHARMACEUTICALS INC.]10Current NDC, Legacy NDC, 3 package rows20241222_c1cb9bb9-fbae-5e5c-e053-2995a90a0d21.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198013naproxen 250 MG Oral TabletPSNc1cb9bb9-fbae-5e5c-e053-2995a90a0d2111
198012naproxen 375 MG Oral TabletPSNc1cb9bb9-fbae-5e5c-e053-2995a90a0d2111
198014naproxen 500 MG Oral TabletPSNc1cb9bb9-fbae-5e5c-e053-2995a90a0d2111
198013naproxen 250 MG Oral TabletSCDc1cb9bb9-fbae-5e5c-e053-2995a90a0d2111
198012naproxen 375 MG Oral TabletSCDc1cb9bb9-fbae-5e5c-e053-2995a90a0d2111
198014naproxen 500 MG Oral TabletSCDc1cb9bb9-fbae-5e5c-e053-2995a90a0d2111
198014naproxen 500 MG Oral TabletPSN12202ef3-c65e-45a6-88ed-5d945d8fd41c5
198014naproxen 500 MG Oral TabletSCD12202ef3-c65e-45a6-88ed-5d945d8fd41c5
198014naproxen 500 MG Oral TabletPSNfb07a76b-98ce-85dd-e053-6294a90aa6a84
198014naproxen 500 MG Oral TabletSCDfb07a76b-98ce-85dd-e053-6294a90aa6a84
198014naproxen 500 MG Oral TabletPSN52503536-593e-808b-e063-6294a90a737f1
198014naproxen 500 MG Oral TabletSCD52503536-593e-808b-e063-6294a90a737f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70010-139-0170010013901100 TABLET in 1 BOTTLE (70010-139-01) 100 tablet2021-04-150000-00-00NoNoCurrent
70010-139-0570010013905500 TABLET in 1 BOTTLE (70010-139-05) 500 tablet2021-04-150000-00-00NoNoCurrent
70010-139-10700100139101000 TABLET in 1 BOTTLE (70010-139-10) 1000 tablet2021-04-150000-00-00NoNoCurrent