Naproxen

Product NDC
66267-373
11-digit product format
662670373
Labeler code
66267
Product ID
66267-373_1fa6c8e0-0ee3-12f2-e063-6294a90a8951
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA091432
Marketing category
ANDA
Marketing start
2016-07-05
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

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 · 16 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66267-373-60557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66267-373-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66267-373-20557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage66267-373-608af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage66267-373-308af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage66267-373-208af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage66267-373-60834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage66267-373-30834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage66267-373-20834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage66267-373-601332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage66267-373-301332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage66267-373-201332a3947898…d4bfe170f9cd…

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…

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
311915Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5e873524-f9fb-fe2d-e053-2991aa0aa0a5Available 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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66267-373-20Naproxen20 in 1 BOTTLETABLET, DELAYED RELEASE204
66267-373-30Naproxen30 in 1 BOTTLETABLET, DELAYED RELEASE304
66267-373-60Naproxen60 in 1 BOTTLETABLET, DELAYED RELEASE604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66267-373-20EA - Each66267-373d601ff1a-1cea-4b1f-8bd5-9f148414ef2912018-01-12
66267-373-60EA - Each66267-373ccce6fe1-f09f-48b5-939c-28aec19d397a12018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66267-373NAPROXEN TABLET, DELAYED RELEASE [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 3 package rows20240815_5e873524-f9fb-fe2d-e053-2991aa0aa0a5.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
ndc (product): 66267-373
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
311915naproxen 500 MG Delayed Release Oral TabletPSN5e873524-f9fb-fe2d-e053-2991aa0aa0a54
311915naproxen 500 MG Delayed Release Oral TabletSCD5e873524-f9fb-fe2d-e053-2991aa0aa0a54
311915naproxen (as naproxen sodium) 500 MG Delayed Release Oral TabletSY5e873524-f9fb-fe2d-e053-2991aa0aa0a54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
66267-373-206626703732020 TABLET, DELAYED RELEASE in 1 BOTTLE (66267-373-20) 2017-11-210000-00-00NoNoCurrent
66267-373-306626703733030 TABLET, DELAYED RELEASE in 1 BOTTLE (66267-373-30) 2017-11-210000-00-00NoNoCurrent
66267-373-606626703736060 TABLET, DELAYED RELEASE in 1 BOTTLE (66267-373-60) 2017-11-210000-00-00NoNoCurrent