Naproxen

Product NDC
45865-948
11-digit product format
458650948
Labeler code
45865
Product ID
45865-948_9add85b6-a077-b8dc-e053-2a95a90a28ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
medsource pharmaceuticals
Application
ANDA091432
Marketing category
ANDA
Marketing start
2016-07-05
Marketing end
0000-00-00
Substance
NAPROXEN
Active strength
375 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct45865-948IInactivated by FDA2026-08-07
excluded packagepackage45865-94845865-948-60IInactivated by FDA2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage45865-948-60IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage45865-948-60IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage45865-948-60IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage45865-948-60IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage45865-948-60IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage45865-948-60IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage45865-948-60UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage45865-948-60UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage45865-948-60UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091432-001NAPROXENNAPROXEN375MGTABLET, DELAYED RELEASE / ORALAB2011-09-19
A091432-002NAPROXENNAPROXEN500MGTABLET, DELAYED RELEASE / ORALAB2011-09-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A091432-001AB
A091432-002AB

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A091432-001NAPROXEN375MGTABLET, DELAYED RELEASE / ORALAB2011-09-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091432-002NAPROXEN500MGTABLET, DELAYED RELEASE / ORALAB2011-09-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091432-001NAPROXEN375MGTABLET, DELAYED RELEASE / ORALAB2011-09-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091432-002NAPROXEN500MGTABLET, DELAYED RELEASE / ORALAB2011-09-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A091432-001NAPROXEN375MGTABLET, DELAYED RELEASE / ORALAB2011-09-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091432-002NAPROXEN500MGTABLET, DELAYED RELEASE / ORALAB2011-09-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091432-001NAPROXEN375MGTABLET, DELAYED RELEASE / ORALAB2011-09-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091432-002NAPROXEN500MGTABLET, DELAYED RELEASE / ORALAB2011-09-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091432-001NAPROXEN375MGTABLET, DELAYED RELEASE / ORALAB2011-09-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091432-002NAPROXEN500MGTABLET, DELAYED RELEASE / ORALAB2011-09-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091432-001NAPROXEN375MGTABLET, DELAYED RELEASE / ORALAB2011-09-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091432-002NAPROXEN500MGTABLET, DELAYED RELEASE / ORALAB2011-09-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091432-001NAPROXEN375MGTABLET, DELAYED RELEASE / ORALAB2011-09-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091432-002NAPROXEN500MGTABLET, DELAYED RELEASE / ORALAB2011-09-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091432-001NAPROXEN375MGTABLET, DELAYED RELEASE / ORALAB2011-09-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091432-002NAPROXEN500MGTABLET, DELAYED RELEASE / ORALAB2011-09-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091432-001NAPROXEN375MGTABLET, DELAYED RELEASE / ORALAB2011-09-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091432-002NAPROXEN500MGTABLET, DELAYED RELEASE / ORALAB2011-09-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091432-001NAPROXEN375MGTABLET, DELAYED RELEASE / ORALAB2011-09-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A091432-002NAPROXEN500MGTABLET, DELAYED RELEASE / ORALAB2011-09-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091432-001NAPROXEN375MGTABLET, DELAYED RELEASE / ORALAB2011-09-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091432-002NAPROXEN500MGTABLET, DELAYED RELEASE / ORALAB2011-09-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091432-001NAPROXEN375MGTABLET, DELAYED RELEASE / ORALAB2011-09-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091432-002NAPROXEN500MGTABLET, DELAYED RELEASE / ORALAB2011-09-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091432-001NAPROXEN375MGTABLET, DELAYED RELEASE / ORALAB2011-09-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091432-002NAPROXEN500MGTABLET, DELAYED RELEASE / ORALAB2011-09-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091432-001NAPROXEN375MGTABLET, DELAYED RELEASE / ORALAB2011-09-198072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091432-002NAPROXEN500MGTABLET, DELAYED RELEASE / ORALAB2011-09-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091432-001NAPROXEN375MGTABLET, DELAYED RELEASE / ORALAB2011-09-195c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091432-002NAPROXEN500MGTABLET, DELAYED RELEASE / ORALAB2011-09-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091432-001NAPROXEN375MGTABLET, DELAYED RELEASE / ORALAB2011-09-195d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091432-002NAPROXEN500MGTABLET, DELAYED RELEASE / ORALAB2011-09-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091432-001NAPROXEN375MGTABLET, DELAYED RELEASE / ORALAB2011-09-194b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091432-002NAPROXEN500MGTABLET, DELAYED RELEASE / ORALAB2011-09-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091432-001NAPROXEN375MGTABLET, DELAYED RELEASE / ORALAB2011-09-1974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091432-002NAPROXEN500MGTABLET, DELAYED RELEASE / ORALAB2011-09-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091432-001NAPROXEN375MGTABLET, DELAYED RELEASE / ORALAB2011-09-19bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091432-002NAPROXEN500MGTABLET, DELAYED RELEASE / ORALAB2011-09-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091432-001NAPROXEN375MGTABLET, DELAYED RELEASE / ORALAB2011-09-19782e0a99824c…
2021-12-28 21:50 UTC2021-12A091432-002NAPROXEN500MGTABLET, DELAYED RELEASE / ORALAB2011-09-19782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A091432-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091432-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091432-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091432-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091432-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091432-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091432-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091432-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091432-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091432-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091432-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091432-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091432-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091432-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091432-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091432-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091432-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091432-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091432-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091432-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091432-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091432-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091432-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091432-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091432-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091432-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091432-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091432-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091432-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091432-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091432-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091432-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091432-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091432-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091432-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091432-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091432-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091432-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091432-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A091432-002AB1782e0a99824c…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-948-60Naproxen60 in 1 BOTTLETABLET, DELAYED RELEASE601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-948NAPROXEN TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 1 package rows20191230_9add85b6-a076-b8dc-e053-2a95a90a28ed.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NaproxenNAPROXENCameron Pharmaceuticals2ae474dd-eaae-4401-8d42-613d672daea02026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091432
application number: ANDA091432
NaproxenNAPROXENSunrise Pharmaceutical, Inc.f2fb222a-b854-4e6f-9027-2e08aed241852025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091432
application number: ANDA091432
NaproxenNAPROXENPD-Rx Pharmaceuticals, Inc.2d01e583-670a-46f4-b5f2-3fad46d0376f2025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091432
application number: ANDA091432
NaproxenNAPROXENBryant Ranch Prepack124af155-0661-4054-9800-de547d8212d72025-09-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091432
application number: ANDA091432
NaproxenNAPROXENNuCare Pharmaceuticals,Inc.5e873524-f9fb-fe2d-e053-2991aa0aa0a52024-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091432
application number: ANDA091432
NaproxenNAPROXENBryant Ranch Prepack74134b90-d4c7-41bd-a1bd-2ac168db596f2024-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091432
application number: ANDA091432
NaproxenNAPROXENProficient Rx LP69a3afd6-d64b-4f07-b848-b0d3fc19f2a22019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091432
application number: ANDA091432
NaproxenNAPROXENCipla USA Inc.e06c2b43-9882-442e-8413-10d9a33aecb92019-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091432
application number: ANDA091432

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
603103naproxen 375 MG Delayed Release Oral TabletPSN9add85b6-a076-b8dc-e053-2a95a90a28ed1
603103naproxen 375 MG Delayed Release Oral TabletSCD9add85b6-a076-b8dc-e053-2a95a90a28ed1
603103naproxen 375 MG (as naproxen sodium 413 MG) Delayed Release Oral TabletSY9add85b6-a076-b8dc-e053-2a95a90a28ed1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45865-948-604586509486060 TABLET, DELAYED RELEASE in 1 BOTTLE (45865-948-60) 2018-12-120000-00-00NoNoCurrent