Naproxen

Product NDC
71335-1869
11-digit product format
713351869
Labeler code
71335
Product ID
71335-1869_3f020a02-71fd-4194-abac-d29da8af014b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212517
Marketing category
ANDA
Marketing start
2020-03-01
Substance
NAPROXEN
Active strength
250 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Naproxen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57Y76R9ATQ
Rxcui198013

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
71335-1869-1Naproxen30 in 1 BOTTLETABLET30106
71335-1869-2Naproxen60 in 1 BOTTLETABLET60106
71335-1869-3Naproxen20 in 1 BOTTLETABLET20106
71335-1869-4Naproxen120 in 1 BOTTLETABLET120106
71335-1869-5Naproxen10 in 1 BOTTLETABLET10106
71335-1869-6Naproxen90 in 1 BOTTLETABLET90106
71335-1869-7Naproxen40 in 1 BOTTLETABLET40106
71335-1869-8Naproxen45 in 1 BOTTLETABLET45106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1869-1EA - Each71335-1869a16bb6ba-b832-4d5f-a359-52b379ee471012021-11-09
71335-1869-2EA - Each71335-18692500b0ad-2731-4ee9-9007-21eb8237a94d12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1869NAPROXEN TABLET [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 8 package rows20240504_2e72de28-e62b-44e0-b17d-500d13e0bcc6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198013naproxen 250 MG Oral TabletPSN2e72de28-e62b-44e0-b17d-500d13e0bcc6106
198013naproxen 250 MG Oral TabletSCD2e72de28-e62b-44e0-b17d-500d13e0bcc6106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1869-17133518690130 TABLET in 1 BOTTLE (71335-1869-1) 30 tablet2021-06-210000-00-00NoNoCurrent
71335-1869-27133518690260 TABLET in 1 BOTTLE (71335-1869-2) 60 tablet2021-06-210000-00-00NoNoCurrent
71335-1869-37133518690320 TABLET in 1 BOTTLE (71335-1869-3) 20 tablet2021-06-210000-00-00NoNoCurrent
71335-1869-471335186904120 TABLET in 1 BOTTLE (71335-1869-4) 120 tablet2021-06-210000-00-00NoNoCurrent
71335-1869-57133518690510 TABLET in 1 BOTTLE (71335-1869-5) 10 tablet2021-06-210000-00-00NoNoCurrent
71335-1869-67133518690690 TABLET in 1 BOTTLE (71335-1869-6) 90 tablet2021-06-210000-00-00NoNoCurrent
71335-1869-77133518690740 TABLET in 1 BOTTLE (71335-1869-7) 40 tablet2021-06-210000-00-00NoNoCurrent
71335-1869-87133518690845 TABLET in 1 BOTTLE (71335-1869-8) 45 tablet2021-06-210000-00-00NoNoCurrent