FDA.reportPublic FDA data

Naproxen

Product NDC
25000-138
Requested package NDC
25000-138-21
11-digit product format
250000138
Labeler code
25000
Product ID
25000-138_e5013319-e2f4-4cd0-9523-1ffd352fe2d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
MARKSANS PHARMA LIMITED
Application
ANDA091416
Marketing category
ANDA
Marketing start
2011-02-28
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
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
ndc (package): 25000-138-21
ndc (product): 25000-138
ndc11 (package): 25000013821
NAPROXENNAPROXENNuCare Pharmaceuticals,Inc.5487dee2-5c37-4348-e054-00144ff8d46c2024-07-17WarningsExact identifier
application applno (ANDA): 091416
application number: ANDA091416
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
NAPROXEN250 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198012Internal RxNorm lookup
198013Internal RxNorm lookup
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
1fdb4cbd-e9e8-47bb-b3d8-1f1ec8f411c8Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25000-138-03Naproxen30 in 1 BOTTLETABLET3014
25000-138-14Naproxen1000 in 1 BOTTLETABLET100014
25000-138-21Naproxen7500 in 1 BAGTABLET750014
25000-138-21Naproxen4 in 1 BOXTABLET414
25000-138-31Naproxen6 in 1 BOXTABLET614
25000-138-31Naproxen7500 in 1 BAGTABLET750014
25000-138-98Naproxen37950 in 1 BAGTABLET3795014
25000-138-98Naproxen1 in 1 BOXTABLET114

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [MARKSANS PHARMA LIMITED]4
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [MARKSANS PHARMA LIMITED]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [MARKSANS PHARMA LIMITED]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [MARKSANS PHARMA LIMITED]4
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [MARKSANS PHARMA LIMITED]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25000-138NAPROXEN TABLET [MARKSANS PHARMA LIMITED]14Current NDC, Legacy NDC, 8 package rows20241219_1fdb4cbd-e9e8-47bb-b3d8-1f1ec8f411c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198013naproxen 250 MG Oral TabletPSN1fdb4cbd-e9e8-47bb-b3d8-1f1ec8f411c814
198012naproxen 375 MG Oral TabletPSN1fdb4cbd-e9e8-47bb-b3d8-1f1ec8f411c814
198014naproxen 500 MG Oral TabletPSN1fdb4cbd-e9e8-47bb-b3d8-1f1ec8f411c814
198013naproxen 250 MG Oral TabletSCD1fdb4cbd-e9e8-47bb-b3d8-1f1ec8f411c814
198012naproxen 375 MG Oral TabletSCD1fdb4cbd-e9e8-47bb-b3d8-1f1ec8f411c814
198014naproxen 500 MG Oral TabletSCD1fdb4cbd-e9e8-47bb-b3d8-1f1ec8f411c814

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25000-138-21250000138214 BAG in 1 BOX (25000-138-21) / 7500 TABLET in 1 BAG4 bag2011-02-280000-00-00NoNoCurrent