FDA.reportPublic FDA data

NAPROXEN

Product NDC
68071-4006
11-digit product format
680714006
Labeler code
68071
Product ID
68071-4006_1d7a3c9a-73d5-5360-e063-6394a90aa3e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NAPROXEN
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA091416
Marketing category
ANDA
Marketing start
2016-07-06
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091416-001NAPROXENNAPROXEN250MGTABLET / ORALAB2011-02-14
A091416-002NAPROXENNAPROXEN375MGTABLET / ORALAB2011-02-14
A091416-003NAPROXENNAPROXEN500MGTABLET / ORALAB2011-02-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A091416-001AB
A091416-002AB
A091416-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A091416-001NAPROXEN250MGTABLET / ORALAB2011-02-14a50c72e98297…
2026-08-01 22:54:322026-06A091416-002NAPROXEN375MGTABLET / ORALAB2011-02-14a50c72e98297…
2026-08-01 22:54:322026-06A091416-003NAPROXEN500MGTABLET / ORALAB2011-02-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A091416-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A091416-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A091416-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NAPROXENNAPROXENNorthwind Health Company, LLCf32d755e-4984-ee40-e053-2995a90a4ebe2026-01-01WarningsExact identifier
application applno (ANDA): 091416
application number: ANDA091416
NAPROXENNAPROXENQPharma Incc0a4839b-7154-c82c-e053-2a95a90a7e6d2025-12-03WarningsExact identifier
application applno (ANDA): 091416
application number: ANDA091416
NAPROXENNAPROXENPD-Rx Pharmaceuticals, Inc.a9f9ce81-9d51-4167-9581-974866a8fe312025-10-17WarningsExact identifier
application applno (ANDA): 091416
application number: ANDA091416
NAPROXENNAPROXENDIRECT RXb1b78c49-82e9-2402-e053-2a95a90ae35f2025-01-17WarningsExact identifier
application applno (ANDA): 091416
application number: ANDA091416
NaproxenNAPROXENAdvanced Rx of Tennessee, LLCaf9a96cf-1cda-8ace-e053-2a95a90a18cc2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091416
application number: ANDA091416
NaproxenNAPROXENMARKSANS PHARMA LIMITED1fdb4cbd-e9e8-47bb-b3d8-1f1ec8f411c82024-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091416
application number: ANDA091416
NAPROXENNAPROXENNuCare Pharmaceuticals,Inc.5487dee2-5c37-4348-e054-00144ff8d46c2024-07-17WarningsExact identifier
application applno (ANDA): 091416
application number: ANDA091416
ndc (product): 68071-4006
NAPROXENNAPROXENNuCare Pharmaceuticals,Inc.71d4a048-ca50-73db-e053-2a95a90ad4652024-06-10WarningsExact identifier
application applno (ANDA): 091416
application number: ANDA091416
NAPROXENNAPROXENNuCare Pharmaceuticals,Inc.69366b55-2687-17a4-e053-2a91aa0a65b32024-06-07Exact identifier
application applno (ANDA): 091416
application number: ANDA091416
NAPROXENNAPROXENAsclemed USA, Inc.a4fcb411-c918-459b-adc6-06dfa8ed8a502022-10-12WarningsExact identifier
application applno (ANDA): 091416
application number: ANDA091416
NAPROXENNAPROXENAphena Pharma Solutions - Tennessee, LLC32693390-763b-46dd-b821-65a7bf3c66712021-04-26WarningsExact identifier
application applno (ANDA): 091416
application number: ANDA091416
NAPROXENNAPROXENBryant Ranch Prepack5d399bf3-db49-411a-91b9-b410d702a65a2020-12-14WarningsExact identifier
application applno (ANDA): 091416
application number: ANDA091416
NAPROXENNAPROXENTIME CAP LABORATORIES4350a2d9-5228-460e-b7b1-27e8fa8467872018-10-09WarningsExact identifier
application applno (ANDA): 091416
application number: ANDA091416

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
57Y76R9ATQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198014Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5487dee2-5c37-4348-e054-00144ff8d46cAvailable on FDA.report

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
68071-4006-12024-07-17C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-22024-07-17C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-32024-07-17C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-42024-07-17C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-52024-07-17C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-62024-07-17C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-72024-07-17C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-92024-07-17C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-12023-01-30C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-22023-01-30C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-32023-01-30C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-42023-01-30C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-52023-01-30C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-62023-01-30C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-72023-01-30C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-92023-01-30C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-12021-02-10C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-22021-02-10C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-32021-02-10C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-42021-02-10C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-52021-02-10C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-62021-02-10C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-72021-02-10C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-92021-02-10C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-12021-01-29C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-22021-01-29C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-32021-01-29C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-42021-01-29C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-52021-01-29C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-62021-01-29C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-72021-01-29C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c
68071-4006-92021-01-29C16284748780-1ba0f9c33-4d75-a910-e053-dadaa90a0b855487dee2-5c37-4348-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4006-1NAPROXEN10 in 1 BOTTLETABLET105
68071-4006-2NAPROXEN20 in 1 BOTTLETABLET205
68071-4006-3NAPROXEN30 in 1 BOTTLETABLET305
68071-4006-4NAPROXEN40 in 1 BOTTLETABLET405
68071-4006-5NAPROXEN15 in 1 BOTTLETABLET155
68071-4006-6NAPROXEN60 in 1 BOTTLETABLET605
68071-4006-7NAPROXEN14 in 1 BOTTLETABLET145
68071-4006-9NAPROXEN90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68071-4006-3EA - Each68071-40061ad25a3c-fb8a-4643-81d1-eaf0f866a40512019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4006NAPROXEN TABLET [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 8 package rows20240719_5487dee2-5c37-4348-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198014naproxen 500 MG Oral TabletPSN5487dee2-5c37-4348-e054-00144ff8d46c5
198014naproxen 500 MG Oral TabletSCD5487dee2-5c37-4348-e054-00144ff8d46c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4006-16807140060110 TABLET in 1 BOTTLE (68071-4006-1) 10 tablet2017-07-170000-00-00NoNoCurrent
68071-4006-26807140060220 TABLET in 1 BOTTLE (68071-4006-2) 20 tablet2017-07-170000-00-00NoNoCurrent
68071-4006-36807140060330 TABLET in 1 BOTTLE (68071-4006-3) 30 tablet2017-07-170000-00-00NoNoCurrent
68071-4006-46807140060440 TABLET in 1 BOTTLE (68071-4006-4) 40 tablet2017-07-170000-00-00NoNoCurrent
68071-4006-56807140060515 TABLET in 1 BOTTLE (68071-4006-5) 15 tablet2017-07-170000-00-00NoNoCurrent
68071-4006-66807140060660 TABLET in 1 BOTTLE (68071-4006-6) 60 tablet2017-07-170000-00-00NoNoCurrent
68071-4006-76807140060714 TABLET in 1 BOTTLE (68071-4006-7) 14 tablet2017-07-170000-00-00NoNoCurrent
68071-4006-96807140060990 TABLET in 1 BOTTLE (68071-4006-9) 90 tablet2017-07-170000-00-00NoNoCurrent