Naproxen

Product NDC: 68462-188
11-digit product format: 684620188
Labeler code: 68462
Product ID: 68462-188_16372549-a419-4920-a200-5128017570ed
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naproxen
Dosage form: TABLET
Route: ORAL
Labeler: Glenmark Pharmaceuticals Inc., USA
Application: ANDA078250
Marketing category: ANDA
Marketing start: 2007-07-01
Substance: NAPROXEN
Active strength: 250 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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078250-001	NAPROXEN	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28
A078250-002	NAPROXEN	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28
A078250-003	NAPROXEN	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078250-001	AB
A078250-002	AB
A078250-003	AB

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078250-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078250-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078250-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078250-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078250-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078250-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078250-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078250-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078250-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078250-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078250-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078250-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078250-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078250-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078250-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078250-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078250-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078250-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078250-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078250-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078250-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078250-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078250-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078250-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078250-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078250-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078250-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078250-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078250-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078250-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078250-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078250-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078250-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078250-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078250-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078250-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078250-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078250-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078250-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078250-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Naproxen
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NAPROXEN	250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9TN87S3A3C	Internal UNII lookup
57Y76R9ATQ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198012	Internal RxNorm lookup
198013	Internal RxNorm lookup
198014	Internal RxNorm lookup
849398	Internal RxNorm lookup
849431	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
6c5bb008-e66f-4ef0-bf84-aca7eb5983e9	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fef6ad89-235f-4274-ba49-a8e53642473e	Product name	2	20250225
87fed3e6-8fba-48ef-96b0-3a7fb54b96ff	Product name	3	20230306
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8	Product name	1	20200623
e76dbbc1-775d-722c-08ff-ed45e8a80def	Product name	3	20181002
6f4f4521-fd56-1ae6-888b-3b021bd75c7c	Product name	1	20140508
ce67e27d-1d21-5465-4409-b0662dd99d4d	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68462-188-01	Naproxen	100 in 1 BOTTLE	TABLET	100		13
68462-188-05	Naproxen	500 in 1 BOTTLE	TABLET	500		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-188-01	EA - Each	68462-188	b1d41af1-4ac7-4f78-8b6f-5dca7f39f33b	1	2012-07-24
68462-188-05	EA - Each	68462-188	c97a3c0c-7864-41af-9a26-b1bad42f0d30	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NAPROXEN	ACTIVE INGREDIENT	57Y76R9ATQ	NAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]	4
NAPROXEN SODIUM	ACTIVE INGREDIENT	9TN87S3A3C	NAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]	4
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]	4
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	NAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]	4
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	NAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	NAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]	4
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	NAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]	4
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	NAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]	4
NAPROXEN	ACTIVE INGREDIENT	57Y76R9ATQ	NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.]	1
NAPROXEN	ACTIVE INGREDIENT	57Y76R9ATQ	NAPROXEN SODIUM TABLET [NORTHWIND PHARMACEUTICALS, LLC]	1
NAPROXEN	ACTIVE INGREDIENT	57Y76R9ATQ	NAPROXEN TABLET [MEDSOURCE PHARMACEUTICALS]	1
NAPROXEN	ACTIVE INGREDIENT	57Y76R9ATQ	NAPROXEN TABLET [CONTRACT PHARMACY SERVICES-PA]	1
NAPROXEN	ACTIVE INGREDIENT	57Y76R9ATQ	NAPROXEN TABLET [REBEL DISTRIBUTORS CORP]	1
NAPROXEN	ACTIVE INGREDIENT	57Y76R9ATQ	NAPROXEN TABLET [PROFICIENT RX LP]	1
NAPROXEN SODIUM	ACTIVE INGREDIENT	9TN87S3A3C	NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.]	1
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN TABLET [CONTRACT PHARMACY SERVICES-PA]	1
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN TABLET [MEDSOURCE PHARMACEUTICALS]	1
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN TABLET [REBEL DISTRIBUTORS CORP]	1
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.]	1
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN TABLET [PROFICIENT RX LP]	1
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN SODIUM TABLET [NORTHWIND PHARMACEUTICALS, LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NAPROXEN TABLET [PROFICIENT RX LP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NAPROXEN TABLET [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NAPROXEN TABLET [CONTRACT PHARMACY SERVICES-PA]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NAPROXEN TABLET [MEDSOURCE PHARMACEUTICALS]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NAPROXEN TABLET [REBEL DISTRIBUTORS CORP]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NAPROXEN TABLET [CONTRACT PHARMACY SERVICES-PA]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NAPROXEN TABLET [PROFICIENT RX LP]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NAPROXEN TABLET [MEDSOURCE PHARMACEUTICALS]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	NAPROXEN TABLET [PROFICIENT RX LP]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	NAPROXEN TABLET [MEDSOURCE PHARMACEUTICALS]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	NAPROXEN TABLET [PROFICIENT RX LP]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	NAPROXEN TABLET [MEDSOURCE PHARMACEUTICALS]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN TABLET [MEDSOURCE PHARMACEUTICALS]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN TABLET [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN TABLET [CONTRACT PHARMACY SERVICES-PA]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN TABLET [PROFICIENT RX LP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	NAPROXEN TABLET [REBEL DISTRIBUTORS CORP]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	NAPROXEN TABLET [CONTRACT PHARMACY SERVICES-PA]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	NAPROXEN TABLET [MEDSOURCE PHARMACEUTICALS]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	NAPROXEN TABLET [PROFICIENT RX LP]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-188	NAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA]	12	Current NDC, Legacy NDC, 2 package rows	20240814_6c5bb008-e66f-4ef0-bf84-aca7eb5983e9.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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen	NAPROXEN	Unit Dose Solutions, Inc.	55652203-e5f3-78dc-e063-6294a90a3e46	2026-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	Coupler LLC	545fe39a-4777-b149-e063-6394a90a53cf	2026-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	Coupler LLC	53e6519a-cb52-85e2-e063-6394a90abdcf	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	Coupler LLC	52b8e52e-73be-3423-e063-6294a90af6e0	2026-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	Bryant Ranch Prepack	0041b483-34db-49a6-8665-f87e286cd0b8	2026-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	A-S Medication Solutions	4e97e645-552d-424b-990a-f94349a86f17	2026-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	A-S Medication Solutions	000155a8-709c-44e5-a75f-cd890f3a7caf	2026-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	A-S Medication Solutions	d06db628-f6f0-48e2-b538-69c0837c49e3	2026-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	A-S Medication Solutions	9d28422f-6f25-4f14-9272-e0907c971f33	2026-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	Preferred Pharmaceuticals Inc.	87acd650-ea8a-4396-be72-5568c4b1755c	2026-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen Sodium	NAPROXEN SODIUM	Glenmark Pharmaceuticals Inc., USA	6c5bb008-e66f-4ef0-bf84-aca7eb5983e9	2025-12-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250 ndc (product): 68462-188
Naproxen	NAPROXEN	American Health Packaging	86a3e612-3bfe-432f-9afd-972bb8a6644e	2025-09-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	A-S Medication Solutions	e63a034d-23ef-458f-88ed-8b6d73699621	2025-04-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	Preferred Pharmaceuticals Inc.	727913f6-9542-4a2d-9318-4b7ff521bffd	2025-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	Advanced Rx of Tennessee, LLC	af9aa7a0-e287-5935-e053-2995a90a1d11	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	A-S Medication Solutions	bce23087-f055-4234-b75d-69dd43233190	2024-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	Bryant Ranch Prepack	da61463f-f87b-4aba-b538-7264252cadb8	2024-09-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	Bryant Ranch Prepack	1fe9a6fc-940e-4a18-b3e9-b204fd67f263	2024-09-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	Boswell Pharmacy Services LLC d/b/a BPS Wholesale	205b1159-06e5-0d48-e063-6294a90acbd8	2024-08-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	NuCare Pharmaceuticals, Inc.	46dd3908-6feb-4f50-e054-00144ff88e88	2024-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
57Y76R9ATQ	NAPROXEN	22204-53-1	NAPROXEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198013	naproxen 250 MG Oral Tablet	PSN	da61463f-f87b-4aba-b538-7264252cadb8	101
198013	naproxen 250 MG Oral Tablet	SCD	da61463f-f87b-4aba-b538-7264252cadb8	101
198013	naproxen 250 MG Oral Tablet	PSN	e63a034d-23ef-458f-88ed-8b6d73699621	23
198013	naproxen 250 MG Oral Tablet	SCD	e63a034d-23ef-458f-88ed-8b6d73699621	23
198013	naproxen 250 MG Oral Tablet	PSN	6c5bb008-e66f-4ef0-bf84-aca7eb5983e9	13
198012	naproxen 375 MG Oral Tablet	PSN	6c5bb008-e66f-4ef0-bf84-aca7eb5983e9	13
198014	naproxen 500 MG Oral Tablet	PSN	6c5bb008-e66f-4ef0-bf84-aca7eb5983e9	13
849398	naproxen sodium 275 MG Oral Tablet	PSN	6c5bb008-e66f-4ef0-bf84-aca7eb5983e9	13
849431	naproxen sodium 550 MG Oral Tablet	PSN	6c5bb008-e66f-4ef0-bf84-aca7eb5983e9	13
198013	naproxen 250 MG Oral Tablet	SCD	6c5bb008-e66f-4ef0-bf84-aca7eb5983e9	13
198012	naproxen 375 MG Oral Tablet	SCD	6c5bb008-e66f-4ef0-bf84-aca7eb5983e9	13
198014	naproxen 500 MG Oral Tablet	SCD	6c5bb008-e66f-4ef0-bf84-aca7eb5983e9	13
849398	naproxen sodium 275 MG Oral Tablet	SCD	6c5bb008-e66f-4ef0-bf84-aca7eb5983e9	13
849431	naproxen sodium 550 MG Oral Tablet	SCD	6c5bb008-e66f-4ef0-bf84-aca7eb5983e9	13
849398	naproxen sodium 275 MG (as naproxen 250 MG) Oral Tablet	SY	6c5bb008-e66f-4ef0-bf84-aca7eb5983e9	13
849431	naproxen sodium 550 MG (as naproxen 500 MG) Oral Tablet	SY	6c5bb008-e66f-4ef0-bf84-aca7eb5983e9	13
198013	naproxen 250 MG Oral Tablet	PSN	c38ae25f-d73e-4f85-b450-87df87e989da	4
198013	naproxen 250 MG Oral Tablet	PSN	aa4d159c-9cbe-4d29-9532-33a312f1ae05	4
198013	naproxen 250 MG Oral Tablet	PSN	8066fff6-a9ba-4a94-9412-7f8ef8c028e2	4
198014	naproxen 500 MG Oral Tablet	PSN	c38ae25f-d73e-4f85-b450-87df87e989da	4
198013	naproxen 250 MG Oral Tablet	SCD	8066fff6-a9ba-4a94-9412-7f8ef8c028e2	4
198013	naproxen 250 MG Oral Tablet	SCD	aa4d159c-9cbe-4d29-9532-33a312f1ae05	4
198013	naproxen 250 MG Oral Tablet	SCD	c38ae25f-d73e-4f85-b450-87df87e989da	4
198014	naproxen 500 MG Oral Tablet	SCD	c38ae25f-d73e-4f85-b450-87df87e989da	4
198013	naproxen 250 MG Oral Tablet	PSN	1f7d2f11-5b62-1c90-e054-00144ff88e88	2
198013	naproxen 250 MG Oral Tablet	SCD	1f7d2f11-5b62-1c90-e054-00144ff88e88	2
198013	naproxen 250 MG Oral Tablet	PSN	1e9675c8-bcff-4621-90f7-b80489e1b840	1
198013	naproxen 250 MG Oral Tablet	PSN	4bbe6e74-b13e-4609-b4cc-aa0b00d66df8	1
198013	naproxen 250 MG Oral Tablet	PSN	2c4f826c-e71b-4462-a025-19730701a9de	1
198012	naproxen 375 MG Oral Tablet	PSN	2c4f826c-e71b-4462-a025-19730701a9de	1
198012	naproxen 375 MG Oral Tablet	PSN	4bbe6e74-b13e-4609-b4cc-aa0b00d66df8	1
198014	naproxen 500 MG Oral Tablet	PSN	2c4f826c-e71b-4462-a025-19730701a9de	1
198014	naproxen 500 MG Oral Tablet	PSN	4bbe6e74-b13e-4609-b4cc-aa0b00d66df8	1
849398	naproxen sodium 275 MG Oral Tablet	PSN	4bbe6e74-b13e-4609-b4cc-aa0b00d66df8	1
849431	naproxen sodium 550 MG Oral Tablet	PSN	4bbe6e74-b13e-4609-b4cc-aa0b00d66df8	1
198013	naproxen 250 MG Oral Tablet	SCD	2c4f826c-e71b-4462-a025-19730701a9de	1
198013	naproxen 250 MG Oral Tablet	SCD	4bbe6e74-b13e-4609-b4cc-aa0b00d66df8	1
198013	naproxen 250 MG Oral Tablet	SCD	1e9675c8-bcff-4621-90f7-b80489e1b840	1
198012	naproxen 375 MG Oral Tablet	SCD	2c4f826c-e71b-4462-a025-19730701a9de	1
198012	naproxen 375 MG Oral Tablet	SCD	4bbe6e74-b13e-4609-b4cc-aa0b00d66df8	1
198014	naproxen 500 MG Oral Tablet	SCD	2c4f826c-e71b-4462-a025-19730701a9de	1
198014	naproxen 500 MG Oral Tablet	SCD	4bbe6e74-b13e-4609-b4cc-aa0b00d66df8	1
849398	naproxen sodium 275 MG Oral Tablet	SCD	4bbe6e74-b13e-4609-b4cc-aa0b00d66df8	1
849431	naproxen sodium 550 MG Oral Tablet	SCD	4bbe6e74-b13e-4609-b4cc-aa0b00d66df8	1
849398	naproxen sodium 275 MG (as naproxen 250 MG) Oral Tablet	SY	4bbe6e74-b13e-4609-b4cc-aa0b00d66df8	1
849431	naproxen sodium 550 MG (as naproxen 500 MG) Oral Tablet	SY	4bbe6e74-b13e-4609-b4cc-aa0b00d66df8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-188-01	68462018801	100 TABLET in 1 BOTTLE (68462-188-01)	100 tablet	2007-07-01	0000-00-00	No	No	Current
68462-188-05	68462018805	500 TABLET in 1 BOTTLE (68462-188-05)	500 tablet	2007-07-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Naproxen	Coupler LLC	2026-06-16	HUMAN PRESCRIPTION DRUG LABEL	1
Naproxen	Glenmark Pharmaceuticals Inc., USA \| Glenmark Pharmaceuticals Limited	2025-12-23	HUMAN PRESCRIPTION DRUG LABEL	13
Naproxen	A-S Medication Solutions	2025-04-17	HUMAN PRESCRIPTION DRUG LABEL	23
Naproxen	Bryant Ranch Prepack	2024-09-05	HUMAN PRESCRIPTION DRUG LABEL	101
Naproxen	REMEDYREPACK INC.	2024-08-08	HUMAN PRESCRIPTION DRUG LABEL	10
NAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP	Proficient Rx LP	2022-04-01	HUMAN PRESCRIPTION DRUG LABEL	4
Naproxen	RPK Pharmaceuticals, Inc.	2022-03-30	HUMAN PRESCRIPTION DRUG LABEL	4
NAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP	NuCare Pharmaceuticals, Inc.	2022-01-14	HUMAN PRESCRIPTION DRUG LABEL	3
NAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP	NuCare Pharmaceuticals, Inc.	2020-01-22	HUMAN PRESCRIPTION DRUG LABEL	2
NAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP	NuCare Pharmaceuticals, Inc.	2020-01-21	HUMAN PRESCRIPTION DRUG LABEL	2
NAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP	Medsource Pharmaceuticals	2019-12-27	HUMAN PRESCRIPTION DRUG LABEL	2
NAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP	Unit Dose Services	2018-02-28	HUMAN PRESCRIPTION DRUG LABEL	4
Naproxen 250 MG	Northwind Pharmaceuticals, LLC	2014-09-02	HUMAN PRESCRIPTION DRUG LABEL	1
Naproxen Tablets, USP Naproxen Sodium Tablets, USP	Rebel Distributors Corp	2012-03-06	HUMAN PRESCRIPTION DRUG LABEL	1
Naproxen Tablets USP Naproxen Sodium Tablets USP	Altura Pharmaceuticals, Inc.	2010-04-27	HUMAN PRESCRIPTION DRUG LABEL	1
Naproxen Tablets USP Naproxen Sodium Tablets USP	Contract Pharmacy Services-PA	2010-03-19	HUMAN PRESCRIPTION DRUG LABEL	1