NAPROXEN

Product NDC
76420-042
11-digit product format
764200042
Labeler code
76420
Product ID
76420-042_ead160e6-aba4-ca0a-e053-2a95a90ab964
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NAPROXEN
Dosage form
TABLET
Route
ORAL
Labeler
Asclemed USA, 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.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A091416-001NAPROXEN250MGTABLET / ORALAB2011-02-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091416-002NAPROXEN375MGTABLET / ORALAB2011-02-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091416-003NAPROXEN500MGTABLET / ORALAB2011-02-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091416-001NAPROXEN250MGTABLET / ORALAB2011-02-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091416-002NAPROXEN375MGTABLET / ORALAB2011-02-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091416-003NAPROXEN500MGTABLET / ORALAB2011-02-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A091416-001NAPROXEN250MGTABLET / ORALAB2011-02-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091416-002NAPROXEN375MGTABLET / ORALAB2011-02-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091416-003NAPROXEN500MGTABLET / ORALAB2011-02-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091416-001NAPROXEN250MGTABLET / ORALAB2011-02-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091416-002NAPROXEN375MGTABLET / ORALAB2011-02-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091416-003NAPROXEN500MGTABLET / ORALAB2011-02-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091416-001NAPROXEN250MGTABLET / ORALAB2011-02-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091416-002NAPROXEN375MGTABLET / ORALAB2011-02-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091416-003NAPROXEN500MGTABLET / ORALAB2011-02-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091416-001NAPROXEN250MGTABLET / ORALAB2011-02-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091416-002NAPROXEN375MGTABLET / ORALAB2011-02-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091416-003NAPROXEN500MGTABLET / ORALAB2011-02-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091416-001NAPROXEN250MGTABLET / ORALAB2011-02-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091416-002NAPROXEN375MGTABLET / ORALAB2011-02-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091416-003NAPROXEN500MGTABLET / ORALAB2011-02-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091416-001NAPROXEN250MGTABLET / ORALAB2011-02-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091416-002NAPROXEN375MGTABLET / ORALAB2011-02-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091416-003NAPROXEN500MGTABLET / ORALAB2011-02-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091416-001NAPROXEN250MGTABLET / ORALAB2011-02-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091416-002NAPROXEN375MGTABLET / ORALAB2011-02-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091416-003NAPROXEN500MGTABLET / ORALAB2011-02-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091416-001NAPROXEN250MGTABLET / ORALAB2011-02-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A091416-002NAPROXEN375MGTABLET / ORALAB2011-02-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A091416-003NAPROXEN500MGTABLET / ORALAB2011-02-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091416-001NAPROXEN250MGTABLET / ORALAB2011-02-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091416-002NAPROXEN375MGTABLET / ORALAB2011-02-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091416-003NAPROXEN500MGTABLET / ORALAB2011-02-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091416-001NAPROXEN250MGTABLET / ORALAB2011-02-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091416-002NAPROXEN375MGTABLET / ORALAB2011-02-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091416-003NAPROXEN500MGTABLET / ORALAB2011-02-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091416-001NAPROXEN250MGTABLET / ORALAB2011-02-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091416-002NAPROXEN375MGTABLET / ORALAB2011-02-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091416-003NAPROXEN500MGTABLET / ORALAB2011-02-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091416-001NAPROXEN250MGTABLET / ORALAB2011-02-148072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A091416-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091416-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091416-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091416-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091416-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091416-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091416-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091416-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091416-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091416-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091416-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091416-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091416-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091416-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091416-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091416-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091416-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091416-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091416-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091416-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091416-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091416-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091416-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091416-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091416-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091416-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091416-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091416-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091416-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091416-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091416-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091416-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091416-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091416-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091416-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091416-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091416-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091416-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091416-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091416-001AB18072bd15b7f6…

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
a4fcb411-c918-459b-adc6-06dfa8ed8a50Available 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
76420-042-01NAPROXEN1 in 1 BOTTLE, PLASTICTABLET12
76420-042-02NAPROXEN2 in 1 BOTTLE, PLASTICTABLET22
76420-042-10NAPROXEN100 in 1 BOTTLE, PLASTICTABLET1002
76420-042-14NAPROXEN14 in 1 BOTTLE, PLASTICTABLET142
76420-042-30NAPROXEN30 in 1 BOTTLE, PLASTICTABLET302
76420-042-60NAPROXEN60 in 1 BOTTLE, PLASTICTABLET602
76420-042-90NAPROXEN90 in 1 BOTTLE, PLASTICTABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-042-01EA - Each76420-042d6ab9467-3c29-468e-b0a8-2096f028e89012022-05-04
76420-042-02EA - Each76420-04274aee297-ab10-4449-80ee-fc005813b12612022-05-04
76420-042-10EA - Each76420-042447c5bd3-c20c-4180-9dac-061ff25eee2f12022-05-04
76420-042-14EA - Each76420-0427a29d39c-818a-4a8d-8ec5-f1f48f91f2de12022-05-04
76420-042-30EA - Each76420-04232abcc89-ecc6-4cc2-8033-f559f3a2fd3512022-05-04
76420-042-60EA - Each76420-0420270a367-569d-44fa-a01a-a7f3791ced6312022-05-04
76420-042-90EA - Each76420-042faf02c0d-6cc7-4171-a2df-c57ffb8fd74f12022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-042NAPROXEN TABLET [ASCLEMED USA, INC.]2Current NDC, Legacy NDC, 7 package rows20221013_a4fcb411-c918-459b-adc6-06dfa8ed8a50.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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
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
ndc (product): 76420-042
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198014naproxen 500 MG Oral TabletPSNa4fcb411-c918-459b-adc6-06dfa8ed8a502
198014naproxen 500 MG Oral TabletSCDa4fcb411-c918-459b-adc6-06dfa8ed8a502

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-042-01764200042011 TABLET in 1 BOTTLE, PLASTIC (76420-042-01) 1 tablet2020-02-050000-00-00NoNoCurrent
76420-042-02764200042022 TABLET in 1 BOTTLE, PLASTIC (76420-042-02) 2 tablet2020-02-050000-00-00NoNoCurrent
76420-042-1076420004210100 TABLET in 1 BOTTLE, PLASTIC (76420-042-10) 100 tablet2020-02-050000-00-00NoNoCurrent
76420-042-147642000421414 TABLET in 1 BOTTLE, PLASTIC (76420-042-14) 14 tablet2020-02-050000-00-00NoNoCurrent
76420-042-307642000423030 TABLET in 1 BOTTLE, PLASTIC (76420-042-30) 30 tablet2020-02-050000-00-00NoNoCurrent
76420-042-607642000426060 TABLET in 1 BOTTLE, PLASTIC (76420-042-60) 60 tablet2020-02-050000-00-00NoNoCurrent
76420-042-907642000429090 TABLET in 1 BOTTLE, PLASTIC (76420-042-90) 90 tablet2020-02-050000-00-00NoNoCurrent