Naproxen

Product NDC
77771-435
11-digit product format
777710435
Labeler code
77771
Product ID
77771-435_3125cb32-f80b-41a2-a05d-e5a35a9c3167
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Radha Pharmaceuticals, Inc.
Application
ANDA212517
Marketing category
ANDA
Marketing start
2021-06-04
Substance
NAPROXEN
Active strength
375 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A212517-001NAPROXENNAPROXEN250MGTABLET / ORALAB2020-02-21
A212517-002NAPROXENNAPROXEN375MGTABLET / ORALAB2020-02-21
A212517-003NAPROXENNAPROXEN500MGTABLET / ORALAB2020-02-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212517-001AB
A212517-002AB
A212517-003AB

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 3 · 117 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A212517-001NAPROXEN250MGTABLET / ORALAB2020-02-2184e616aacf4f…
2026-09-14 22:38:342026-08A212517-002NAPROXEN375MGTABLET / ORALAB2020-02-2184e616aacf4f…
2026-09-14 22:38:342026-08A212517-003NAPROXEN500MGTABLET / ORALAB2020-02-2184e616aacf4f…
2026-08-18 06:07:402026-07A212517-001NAPROXEN250MGTABLET / ORALAB2020-02-21caaa826d4ba7…
2026-08-18 06:07:402026-07A212517-002NAPROXEN375MGTABLET / ORALAB2020-02-21caaa826d4ba7…
2026-08-18 06:07:402026-07A212517-003NAPROXEN500MGTABLET / ORALAB2020-02-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212517-001NAPROXEN250MGTABLET / ORALAB2020-02-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212517-002NAPROXEN375MGTABLET / ORALAB2020-02-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212517-003NAPROXEN500MGTABLET / ORALAB2020-02-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212517-001NAPROXEN250MGTABLET / ORALAB2020-02-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212517-002NAPROXEN375MGTABLET / ORALAB2020-02-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212517-003NAPROXEN500MGTABLET / ORALAB2020-02-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212517-001NAPROXEN250MGTABLET / ORALAB2020-02-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212517-002NAPROXEN375MGTABLET / ORALAB2020-02-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212517-003NAPROXEN500MGTABLET / ORALAB2020-02-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212517-001NAPROXEN250MGTABLET / ORALAB2020-02-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212517-002NAPROXEN375MGTABLET / ORALAB2020-02-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212517-003NAPROXEN500MGTABLET / ORALAB2020-02-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212517-001NAPROXEN250MGTABLET / ORALAB2020-02-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212517-002NAPROXEN375MGTABLET / ORALAB2020-02-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212517-003NAPROXEN500MGTABLET / ORALAB2020-02-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212517-001NAPROXEN250MGTABLET / ORALAB2020-02-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212517-002NAPROXEN375MGTABLET / ORALAB2020-02-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212517-003NAPROXEN500MGTABLET / ORALAB2020-02-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212517-001NAPROXEN250MGTABLET / ORALAB2020-02-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212517-002NAPROXEN375MGTABLET / ORALAB2020-02-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212517-003NAPROXEN500MGTABLET / ORALAB2020-02-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212517-001NAPROXEN250MGTABLET / ORALAB2020-02-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212517-002NAPROXEN375MGTABLET / ORALAB2020-02-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212517-003NAPROXEN500MGTABLET / ORALAB2020-02-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212517-001NAPROXEN250MGTABLET / ORALAB2020-02-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212517-002NAPROXEN375MGTABLET / ORALAB2020-02-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212517-003NAPROXEN500MGTABLET / ORALAB2020-02-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212517-001NAPROXEN250MGTABLET / ORALAB2020-02-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A212517-002NAPROXEN375MGTABLET / ORALAB2020-02-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A212517-003NAPROXEN500MGTABLET / ORALAB2020-02-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212517-001NAPROXEN250MGTABLET / ORALAB2020-02-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212517-002NAPROXEN375MGTABLET / ORALAB2020-02-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212517-003NAPROXEN500MGTABLET / ORALAB2020-02-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212517-001NAPROXEN250MGTABLET / ORALAB2020-02-21301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 117 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A212517-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A212517-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A212517-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A212517-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A212517-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A212517-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212517-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212517-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212517-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212517-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212517-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212517-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212517-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212517-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212517-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212517-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212517-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212517-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212517-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212517-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212517-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212517-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212517-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212517-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212517-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212517-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212517-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212517-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212517-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212517-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212517-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212517-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212517-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212517-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A212517-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A212517-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212517-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212517-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212517-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212517-001AB1301d65b070ca…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN375 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
1a2b9a82-5b79-45ee-94ed-7a6f8c8b5170Available 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
77771-435-01Naproxen100 in 1 BOTTLETABLET1003
77771-435-05Naproxen500 in 1 BOTTLETABLET5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
77771-435-01EA - Each77771-435c08e551e-c469-421d-9520-167a21bd7c2e12021-07-15
77771-435-05EA - Each77771-435de480dbc-2df9-4935-b920-17c4291a23ea12021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77771-435NAPROXEN TABLET [RADHA PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 2 package rows20231109_1a2b9a82-5b79-45ee-94ed-7a6f8c8b5170.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 2 of 2 · 40 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NaproxenNAPROXENNorthwind Health Company, LLCc986ba9a-6f48-8347-e053-2a95a90aa1c12026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212517
application number: ANDA212517
NaproxenNAPROXENPHOENIX RX LLC43912294-77c9-eda8-e063-6394a90adf0a2025-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212517
application number: ANDA212517
NaproxenNAPROXENA-S Medication Solutions8c3398bd-66b1-4a14-8aaa-e4a2d6749a082025-11-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212517
application number: ANDA212517
NaproxenNAPROXENMedcore LLC129392c8-8ce1-4b78-8863-042db880095f2025-10-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212517
application number: ANDA212517
NaproxenNAPROXENA-S Medication Solutionscfa88511-40bb-4658-b606-44c68d0746b72025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212517
application number: ANDA212517
NaproxenNAPROXENA-S Medication Solutionsb500bdba-946a-41ff-855c-1f2937547d012025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212517
application number: ANDA212517
NaproxenNAPROXENProficient Rx LPe64b3b36-f96e-463e-aca8-8f6e86724bcf2025-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212517
application number: ANDA212517
NaproxenNAPROXENA-S Medication Solutions7fef9311-471b-472c-b4f2-c952a2b3a2552025-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212517
application number: ANDA212517
NaproxenNAPROXENAsclemed USA, Inc.1e406e47-408a-48cc-921e-52882a11581c2025-04-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212517
application number: ANDA212517
NaproxenNAPROXENDirect_Rxf499a207-02c8-a338-e053-2995a90accc02025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212517
application number: ANDA212517
NaproxenNAPROXENAdvanced Rx Pharmacy of Tennessee, LLCd292f376-1844-b01c-e053-2a95a90a09272024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212517
application number: ANDA212517
NaproxenNAPROXENQuality Care Products, LLC1acfb8cc-6faf-4b3e-9304-4819c42de0a62024-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212517
application number: ANDA212517
NaproxenNAPROXENAdvanced Rx Pharmacy of Tennessee, LLC1431b769-5535-78d6-e063-6394a90a84232024-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212517
application number: ANDA212517
NaproxenNAPROXENAsclemed USA, Inc.5a48c0d4-37bf-4c26-a9a7-5c67ff2adb4b2024-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212517
application number: ANDA212517
NaproxenNAPROXENMedsource Pharmaceuticals12648efc-3be8-a915-e063-6394a90a36202024-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212517
application number: ANDA212517
NaproxenNAPROXENBryant Ranch Prepack1cdcaba5-5550-40f6-94cc-b0a98cc17d3c2024-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212517
application number: ANDA212517
NaproxenNAPROXENBryant Ranch Prepackd564f52d-171c-4e7d-974c-3a0e192e6c122024-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212517
application number: ANDA212517
NaproxenNAPROXENProficient Rx LPd0670241-f1f9-4fdf-83d4-547e7b8008112022-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212517
application number: ANDA212517
NaproxenNAPROXENAphena Pharma Solutions - Tennessee, LLC98efdeb8-ea38-456e-953f-ba589727f2842021-11-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212517
application number: ANDA212517
NaproxenNAPROXENAphena Pharma Solutions - Tennessee, LLC9c963e77-6e05-47d0-a8d3-e581777377b92021-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212517
application number: ANDA212517

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198013naproxen 250 MG Oral TabletPSN1a2b9a82-5b79-45ee-94ed-7a6f8c8b51703
198012naproxen 375 MG Oral TabletPSN1a2b9a82-5b79-45ee-94ed-7a6f8c8b51703
198014naproxen 500 MG Oral TabletPSN1a2b9a82-5b79-45ee-94ed-7a6f8c8b51703
198013naproxen 250 MG Oral TabletSCD1a2b9a82-5b79-45ee-94ed-7a6f8c8b51703
198012naproxen 375 MG Oral TabletSCD1a2b9a82-5b79-45ee-94ed-7a6f8c8b51703
198014naproxen 500 MG Oral TabletSCD1a2b9a82-5b79-45ee-94ed-7a6f8c8b51703
198013naproxen 250 MG Oral TabletPSN9c963e77-6e05-47d0-a8d3-e581777377b91
198012naproxen 375 MG Oral TabletPSN9c963e77-6e05-47d0-a8d3-e581777377b91
198013naproxen 250 MG Oral TabletSCD9c963e77-6e05-47d0-a8d3-e581777377b91
198012naproxen 375 MG Oral TabletSCD9c963e77-6e05-47d0-a8d3-e581777377b91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77771-435-0177771043501100 TABLET in 1 BOTTLE (77771-435-01) 100 tablet2021-06-040000-00-00NoNoCurrent
77771-435-0577771043505500 TABLET in 1 BOTTLE (77771-435-05) 500 tablet2021-06-040000-00-00NoNoCurrent