Naproxen

Product NDC
53746-190
11-digit product format
537460190
Labeler code
53746
Product ID
53746-190_e54d008a-9b47-42fa-a8c1-23dc72527132
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA075927
Marketing category
ANDA
Marketing start
2010-02-18
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
A075927-001NAPROXENNAPROXEN250MGTABLET / ORALAB2001-12-18
A075927-002NAPROXENNAPROXEN375MGTABLET / ORALAB2001-12-18
A075927-003NAPROXENNAPROXEN500MGTABLET / ORALAB2001-12-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075927-001AB
A075927-002AB
A075927-003AB

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 UTC2026-02A075927-001NAPROXEN250MGTABLET / ORALAB2001-12-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075927-002NAPROXEN375MGTABLET / ORALAB2001-12-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075927-003NAPROXEN500MGTABLET / ORALAB2001-12-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075927-001NAPROXEN250MGTABLET / ORALAB2001-12-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075927-002NAPROXEN375MGTABLET / ORALAB2001-12-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075927-003NAPROXEN500MGTABLET / ORALAB2001-12-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A075927-001NAPROXEN250MGTABLET / ORALAB2001-12-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075927-002NAPROXEN375MGTABLET / ORALAB2001-12-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075927-003NAPROXEN500MGTABLET / ORALAB2001-12-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075927-001NAPROXEN250MGTABLET / ORALAB2001-12-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075927-002NAPROXEN375MGTABLET / ORALAB2001-12-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075927-003NAPROXEN500MGTABLET / ORALAB2001-12-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075927-001NAPROXEN250MGTABLET / ORALAB2001-12-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075927-002NAPROXEN375MGTABLET / ORALAB2001-12-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075927-003NAPROXEN500MGTABLET / ORALAB2001-12-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075927-001NAPROXEN250MGTABLET / ORALAB2001-12-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075927-002NAPROXEN375MGTABLET / ORALAB2001-12-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075927-003NAPROXEN500MGTABLET / ORALAB2001-12-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075927-001NAPROXEN250MGTABLET / ORALAB2001-12-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075927-002NAPROXEN375MGTABLET / ORALAB2001-12-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075927-003NAPROXEN500MGTABLET / ORALAB2001-12-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075927-001NAPROXEN250MGTABLET / ORALAB2001-12-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075927-002NAPROXEN375MGTABLET / ORALAB2001-12-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075927-003NAPROXEN500MGTABLET / ORALAB2001-12-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075927-001NAPROXEN250MGTABLET / ORALAB2001-12-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075927-002NAPROXEN375MGTABLET / ORALAB2001-12-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075927-003NAPROXEN500MGTABLET / ORALAB2001-12-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075927-001NAPROXEN250MGTABLET / ORALAB2001-12-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A075927-002NAPROXEN375MGTABLET / ORALAB2001-12-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A075927-003NAPROXEN500MGTABLET / ORALAB2001-12-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075927-001NAPROXEN250MGTABLET / ORALAB2001-12-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075927-002NAPROXEN375MGTABLET / ORALAB2001-12-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075927-003NAPROXEN500MGTABLET / ORALAB2001-12-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075927-001NAPROXEN250MGTABLET / ORALAB2001-12-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075927-002NAPROXEN375MGTABLET / ORALAB2001-12-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075927-003NAPROXEN500MGTABLET / ORALAB2001-12-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075927-001NAPROXEN250MGTABLET / ORALAB2001-12-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075927-002NAPROXEN375MGTABLET / ORALAB2001-12-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075927-003NAPROXEN500MGTABLET / ORALAB2001-12-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075927-001NAPROXEN250MGTABLET / ORALAB2001-12-188072bd15b7f6…

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 UTC2026-02A075927-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075927-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075927-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075927-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075927-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075927-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075927-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075927-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075927-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075927-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075927-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075927-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075927-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075927-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075927-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075927-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075927-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075927-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075927-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075927-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075927-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075927-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075927-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075927-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075927-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075927-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075927-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075927-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075927-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075927-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075927-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075927-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075927-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075927-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075927-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075927-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075927-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075927-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075927-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075927-001AB18072bd15b7f6…

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 · 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
2718e0b7-1ce6-457e-bee9-11b634dfd353Available 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#

NDC, Effective, Related label table
NDCEffectiveRelated label
53746-190-012021-02-17These highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
53746-190-052021-02-17These highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
53746-190-102021-02-17These highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
53746-190-012021-01-29These highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
53746-190-052021-01-29These highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
53746-190-102021-01-29These highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53746-190-01Naproxen100 in 1 BOTTLETABLET10027
53746-190-05Naproxen500 in 1 BOTTLETABLET50027
53746-190-10Naproxen1000 in 1 BOTTLETABLET100027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53746-190-01EA - Each53746-190185bf99b-9aab-4860-9049-dc4a9f5f87e312012-07-24
53746-190-05EA - Each53746-19011a5fe55-1051-4176-9998-c80f315c3a1612012-07-24
53746-190-10EA - Each53746-1905718b201-64a2-4881-a14d-982add0c8c2c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
POVIDONESINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [REBEL DISTRIBUTORS CORP.]3
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [UNIT DOSE SERVICES]3
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [UNIT DOSE SERVICES]3
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [REBEL DISTRIBUTORS CORP.]3
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [UNIT DOSE SERVICES]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [REBEL DISTRIBUTORS CORP.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [REBEL DISTRIBUTORS CORP.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [UNIT DOSE SERVICES]3
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [UNIT DOSE SERVICES]3
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [REBEL DISTRIBUTORS CORP.]3
POVIDONESINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [PD-RX PHARMACEUTICALS, INC.]2
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [PREFERRED PHARMACEUTICALS, INC.]2
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [BRYANT RANCH PREPACK]2
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [BLENHEIM PHARMACAL, INC.]2
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [PROFICIENT RX LP]2
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN (NAPROXEN) TABLET [PD-RX PHARMACEUTICALS, INC.]2
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [KELTMAN PHARMACEUTICALS INC.]2
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [KELTMAN PHARMACEUTICALS INC.]2
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [PROFICIENT RX LP]2
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [BRYANT RANCH PREPACK]2
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN (NAPROXEN) TABLET [PD-RX PHARMACEUTICALS, INC.]2
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [BLENHEIM PHARMACAL, INC.]2
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [PD-RX PHARMACEUTICALS, INC.]2
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [PREFERRED PHARMACEUTICALS, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [PREFERRED PHARMACEUTICALS, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN (NAPROXEN) TABLET [PD-RX PHARMACEUTICALS, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [PROFICIENT RX LP]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [BRYANT RANCH PREPACK]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [KELTMAN PHARMACEUTICALS INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [PD-RX PHARMACEUTICALS, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [PREFERRED PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN (NAPROXEN) TABLET [PD-RX PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [PD-RX PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [BRYANT RANCH PREPACK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [PROFICIENT RX LP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [KELTMAN PHARMACEUTICALS INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [PD-RX PHARMACEUTICALS, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [KELTMAN PHARMACEUTICALS INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN (NAPROXEN) TABLET [PD-RX PHARMACEUTICALS, INC.]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [PREFERRED PHARMACEUTICALS, INC.]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [BLENHEIM PHARMACAL, INC.]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [PROFICIENT RX LP]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [BRYANT RANCH PREPACK]2
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [BLENHEIM PHARMACAL, INC.]1
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [BLENHEIM PHARMACAL,INC.]1
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [AIDAREX PHARMACEUTICALS LLC]1
NAPROXENACTIVE INGREDIENT57Y76R9ATQCOMFORT PAC WITH NAPROXEN (NAPROXEN) KIT [PD-RX PHARMACEUTICALS, INC.]1
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [LIBERTY PHARMACEUTICALS, INC.]1
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [AVKARE, INC.]1
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [LIBERTY PHARMACEUTICALS, INC.]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [AIDAREX PHARMACEUTICALS LLC]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [AVKARE, INC.]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [BLENHEIM PHARMACAL, INC.]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [LIBERTY PHARMACEUTICALS, INC.]1
NAPROXENACTIVE MOIETY57Y76R9ATQCOMFORT PAC WITH NAPROXEN (NAPROXEN) KIT [PD-RX PHARMACEUTICALS, INC.]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [BLENHEIM PHARMACAL,INC.]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [LIBERTY PHARMACEUTICALS, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [BLENHEIM PHARMACAL, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [AIDAREX PHARMACEUTICALS LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [LIBERTY PHARMACEUTICALS, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [AVKARE, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [LIBERTY PHARMACEUTICALS, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48COMFORT PAC WITH NAPROXEN (NAPROXEN) KIT [PD-RX PHARMACEUTICALS, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [BLENHEIM PHARMACAL,INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [AVKARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [BLENHEIM PHARMACAL,INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30COMFORT PAC WITH NAPROXEN (NAPROXEN) KIT [PD-RX PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [LIBERTY PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [LIBERTY PHARMACEUTICALS, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [AVKARE, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [BLENHEIM PHARMACAL, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ECOMFORT PAC WITH NAPROXEN (NAPROXEN) KIT [PD-RX PHARMACEUTICALS, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XNAPROXEN TABLET [LIBERTY PHARMACEUTICALS, INC.]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [AIDAREX PHARMACEUTICALS LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [BLENHEIM PHARMACAL,INC.]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [LIBERTY PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53746-190NAPROXEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]27Current NDC, Legacy NDC, 3 package rows20250316_2718e0b7-1ce6-457e-bee9-11b634dfd353.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 · 18 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NaproxenNAPROXENPreferred Pharmaceuticals Inc.c5e52ddd-a909-487a-bb46-01ad356906652026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075927
application number: ANDA075927
NaproxenNAPROXENA-S Medication Solutionsc5c8b6fd-f3f5-4fed-823c-9a80386b27b12026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075927
application number: ANDA075927
NaproxenNAPROXENAvPAKe6fbf8f1-b064-658d-17bb-e7d6320aa45f2026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075927
application number: ANDA075927
NaproxenNAPROXENNorthwind Health Company, LLCab6ec2c9-5df9-346c-e053-2a95a90ac81d2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075927
application number: ANDA075927
NaproxenNAPROXENQPharma, Inc.307aa67f-53b9-4c60-a328-091bbf6338d42025-12-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075927
application number: ANDA075927
NaproxenNAPROXENPD-Rx Pharmaceuticals, Inc.29d98cf3-a0f2-3f89-e054-00144ff88e882025-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075927
application number: ANDA075927
NaproxenNAPROXENPD-Rx Pharmaceuticals, Inc.6573681e-e9be-440f-a818-a533b744648e2025-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075927
application number: ANDA075927
NaproxenNAPROXENAmneal Pharmaceuticals LLCc43a43e2-e867-448d-8f59-3efc7c077cbc2025-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075927
application number: ANDA075927
NaproxenNAPROXENBryant Ranch Prepack9d7bc470-fbba-40a6-a56c-f681a3cee9cf2025-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075927
application number: ANDA075927
NaproxenNAPROXENAmneal Pharmaceuticals of New York LLC2718e0b7-1ce6-457e-bee9-11b634dfd3532025-03-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075927
application number: ANDA075927
ndc (product): 53746-190
NaproxenNAPROXENAdvanced Rx of Tennessee, LLCaf9ad850-57b5-a21d-e053-2a95a90ae68e2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075927
application number: ANDA075927
NaproxenNAPROXENAdvanced Rx of Tennessee, LLCaf9a94a8-3825-eabd-e053-2a95a90acd582024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075927
application number: ANDA075927
NaproxenNAPROXENBryant Ranch Prepacka4f31070-4ee1-4d64-8b1d-40b9011e124b2024-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075927
application number: ANDA075927
NaproxenNAPROXENA-S Medication Solutions80233fa5-f8b4-42d5-a8c9-4a1d8fd4aba42023-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075927
application number: ANDA075927
NaproxenNAPROXENA-S Medication Solutions21930f73-d3c2-4462-a487-74ed871b74b22023-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075927
application number: ANDA075927
NaproxenNAPROXENA-S Medication Solutionsa5ea3a84-7acd-4f24-9f0f-9f871ce1b5f42023-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075927
application number: ANDA075927
NaproxenNAPROXENProficient Rx LPfc3ee94a-adb7-411e-a662-2f2c6ddbabaf2021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075927
application number: ANDA075927
NaproxenNAPROXENNCS HealthCare of KY, Inc dba Vangard Labs62a12771-bde9-4bc3-9ce9-672c8e31f0202017-10-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075927
application number: ANDA075927

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198013naproxen 250 MG Oral TabletPSN53865075-2d8d-4390-b392-5645cfd90e7b34
198012naproxen 375 MG Oral TabletPSN53865075-2d8d-4390-b392-5645cfd90e7b34
198014naproxen 500 MG Oral TabletPSN53865075-2d8d-4390-b392-5645cfd90e7b34
198013naproxen 250 MG Oral TabletSCD53865075-2d8d-4390-b392-5645cfd90e7b34
198012naproxen 375 MG Oral TabletSCD53865075-2d8d-4390-b392-5645cfd90e7b34
198014naproxen 500 MG Oral TabletSCD53865075-2d8d-4390-b392-5645cfd90e7b34
198013naproxen 250 MG Oral TabletPSN2718e0b7-1ce6-457e-bee9-11b634dfd35327
198012naproxen 375 MG Oral TabletPSN2718e0b7-1ce6-457e-bee9-11b634dfd35327
198014naproxen 500 MG Oral TabletPSN2718e0b7-1ce6-457e-bee9-11b634dfd35327
198013naproxen 250 MG Oral TabletSCD2718e0b7-1ce6-457e-bee9-11b634dfd35327
198012naproxen 375 MG Oral TabletSCD2718e0b7-1ce6-457e-bee9-11b634dfd35327
198014naproxen 500 MG Oral TabletSCD2718e0b7-1ce6-457e-bee9-11b634dfd35327
198014naproxen 500 MG Oral TabletPSN0fd4b067-560b-4425-bd9b-9f27f31e0a437
198014naproxen 500 MG Oral TabletSCD0fd4b067-560b-4425-bd9b-9f27f31e0a437
198014naproxen 500 MG Oral TabletPSN40d5f084-756d-33cf-e054-00144ff8d46c6
198014naproxen 500 MG Oral TabletSCD40d5f084-756d-33cf-e054-00144ff8d46c6
198014naproxen 500 MG Oral TabletPSNfc3ee94a-adb7-411e-a662-2f2c6ddbabaf5
198014naproxen 500 MG Oral TabletSCDfc3ee94a-adb7-411e-a662-2f2c6ddbabaf5
198013naproxen 250 MG Oral TabletPSN8c7b265e-7500-464a-854e-9c4a22c8d2113
198013naproxen 250 MG Oral TabletPSN92c48cd9-e645-4871-a0ad-9ea56623edb63
198012naproxen 375 MG Oral TabletPSN8c7b265e-7500-464a-854e-9c4a22c8d2113
198012naproxen 375 MG Oral TabletPSN92c48cd9-e645-4871-a0ad-9ea56623edb63
198012naproxen 375 MG Oral TabletPSN6d757241-53f8-4498-999a-87dfe3cb4d173
198014naproxen 500 MG Oral TabletPSN92c48cd9-e645-4871-a0ad-9ea56623edb63
198014naproxen 500 MG Oral TabletPSN8c7b265e-7500-464a-854e-9c4a22c8d2113
198014naproxen 500 MG Oral TabletPSN6d757241-53f8-4498-999a-87dfe3cb4d173
198013naproxen 250 MG Oral TabletSCD8c7b265e-7500-464a-854e-9c4a22c8d2113
198013naproxen 250 MG Oral TabletSCD92c48cd9-e645-4871-a0ad-9ea56623edb63
198012naproxen 375 MG Oral TabletSCD92c48cd9-e645-4871-a0ad-9ea56623edb63
198012naproxen 375 MG Oral TabletSCD8c7b265e-7500-464a-854e-9c4a22c8d2113
198012naproxen 375 MG Oral TabletSCD6d757241-53f8-4498-999a-87dfe3cb4d173
198014naproxen 500 MG Oral TabletSCD92c48cd9-e645-4871-a0ad-9ea56623edb63
198014naproxen 500 MG Oral TabletSCD8c7b265e-7500-464a-854e-9c4a22c8d2113
198014naproxen 500 MG Oral TabletSCD6d757241-53f8-4498-999a-87dfe3cb4d173
198013naproxen 250 MG Oral TabletPSN1a10952e-0662-4f2c-bd02-28dd4eee138f2
198012naproxen 375 MG Oral TabletPSN1a10952e-0662-4f2c-bd02-28dd4eee138f2
198014naproxen 500 MG Oral TabletPSN1a10952e-0662-4f2c-bd02-28dd4eee138f2
198014naproxen 500 MG Oral TabletPSNf4d9bd36-b960-47f6-afde-22f5012d419b2
198013naproxen 250 MG Oral TabletSCD1a10952e-0662-4f2c-bd02-28dd4eee138f2
198012naproxen 375 MG Oral TabletSCD1a10952e-0662-4f2c-bd02-28dd4eee138f2
198014naproxen 500 MG Oral TabletSCDf4d9bd36-b960-47f6-afde-22f5012d419b2
198014naproxen 500 MG Oral TabletSCD1a10952e-0662-4f2c-bd02-28dd4eee138f2
198013naproxen 250 MG Oral TabletPSNf23569ab-d9ac-45e8-b8f3-8d0ba612fc2d1
198014naproxen 500 MG Oral TabletPSN7466d0fe-819b-4634-a29f-bd838edc39711
198014naproxen 500 MG Oral TabletPSN5e802e0f-8f76-499e-9448-2c9fb8cab96b1
198014naproxen 500 MG Oral TabletPSN17139481-c7ac-6162-e054-00144ff8d46c1
198014naproxen 500 MG Oral TabletPSN4054e004-de40-4e51-bd37-ce9d04eef1641
198014naproxen 500 MG Oral TabletPSN942c2438-9fe9-4f31-9617-3c6d029154d31
198014naproxen 500 MG Oral TabletPSNcbe1bcdc-8c9b-4ab0-97ad-6d6ef2fa544b1
198014naproxen 500 MG Oral TabletPSNf23569ab-d9ac-45e8-b8f3-8d0ba612fc2d1
198013naproxen 250 MG Oral TabletSCDf23569ab-d9ac-45e8-b8f3-8d0ba612fc2d1
198014naproxen 500 MG Oral TabletSCD17139481-c7ac-6162-e054-00144ff8d46c1
198014naproxen 500 MG Oral TabletSCDf23569ab-d9ac-45e8-b8f3-8d0ba612fc2d1
198014naproxen 500 MG Oral TabletSCDcbe1bcdc-8c9b-4ab0-97ad-6d6ef2fa544b1
198014naproxen 500 MG Oral TabletSCD942c2438-9fe9-4f31-9617-3c6d029154d31
198014naproxen 500 MG Oral TabletSCD7466d0fe-819b-4634-a29f-bd838edc39711
198014naproxen 500 MG Oral TabletSCD5e802e0f-8f76-499e-9448-2c9fb8cab96b1
198014naproxen 500 MG Oral TabletSCD4054e004-de40-4e51-bd37-ce9d04eef1641

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53746-190-0153746019001100 TABLET in 1 BOTTLE (53746-190-01) 100 tablet2010-02-180000-00-00NoNoCurrent
53746-190-0553746019005500 TABLET in 1 BOTTLE (53746-190-05) 500 tablet2010-02-180000-00-00NoNoCurrent
53746-190-10537460190101000 TABLET in 1 BOTTLE (53746-190-10) 1000 tablet2010-02-180000-00-00NoNoCurrent