Naproxen Sodium

Product NDC: 68462-178
11-digit product format: 684620178
Labeler code: 68462
Product ID: 68462-178_16372549-a419-4920-a200-5128017570ed
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naproxen Sodium
Dosage form: TABLET
Route: ORAL
Labeler: Glenmark Pharmaceuticals Inc., USA
Application: ANDA078314
Marketing category: ANDA
Marketing start: 2007-08-01
Substance: NAPROXEN SODIUM
Active strength: 275 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 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078314-001	NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB		2007-04-27
A078314-002	NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB		2007-04-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078314-001	AB
A078314-002	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 3 · 84 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
2026-08-18 06:07:40	2026-07	A078314-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078314-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078314-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078314-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078314-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078314-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078314-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078314-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078314-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078314-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078314-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078314-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078314-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078314-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078314-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078314-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078314-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078314-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078314-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078314-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078314-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078314-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078314-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078314-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078314-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078314-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078314-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078314-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078314-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078314-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078314-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078314-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078314-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078314-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078314-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078314-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078314-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078314-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078314-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078314-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-27	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A078314-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078314-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078314-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078314-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078314-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078314-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078314-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078314-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078314-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078314-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078314-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078314-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078314-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078314-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078314-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078314-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078314-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078314-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078314-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078314-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078314-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078314-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078314-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078314-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078314-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078314-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078314-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078314-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078314-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078314-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078314-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078314-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078314-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078314-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078314-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078314-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078314-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078314-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078314-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078314-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NAPROXEN SODIUM	275 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
57Y76R9ATQ	Internal UNII lookup
9TN87S3A3C	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
68462-178-01	Naproxen Sodium	100 in 1 BOTTLE	TABLET	100		13
68462-178-05	Naproxen Sodium	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
68462-178-01	EA - Each	68462-178	6bd186e4-ceb1-49d9-9eca-4216c2ca2edc	1	2012-07-24
68462-178-05	EA - Each	68462-178	66b86afb-bcb7-4e8a-90c5-2960d9a5c774	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 SODIUM	ACTIVE INGREDIENT	9TN87S3A3C	NAPROXEN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	3
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NAPROXEN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	3
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NAPROXEN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	3
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	NAPROXEN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NAPROXEN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.]	3
NAPROXEN	ACTIVE INGREDIENT	57Y76R9ATQ	NAPROXEN TABLET NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]	2
NAPROXEN SODIUM	ACTIVE INGREDIENT	9TN87S3A3C	NAPROXEN SODIUM TABLET [BRYANT RANCH PREPACK]	2
NAPROXEN SODIUM	ACTIVE INGREDIENT	9TN87S3A3C	NAPROXEN TABLET NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]	2
NAPROXEN SODIUM	ACTIVE INGREDIENT	9TN87S3A3C	NAPROXEN SODIUM TABLET [MEDSOURCE PHARMACEUTICALS]	2
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN SODIUM TABLET [MEDSOURCE PHARMACEUTICALS]	2
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN TABLET NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]	2
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN SODIUM TABLET [BRYANT RANCH PREPACK]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NAPROXEN SODIUM TABLET [BRYANT RANCH PREPACK]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NAPROXEN TABLET NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NAPROXEN SODIUM TABLET [MEDSOURCE PHARMACEUTICALS]	2
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NAPROXEN TABLET NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NAPROXEN TABLET NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NAPROXEN SODIUM TABLET [MEDSOURCE PHARMACEUTICALS]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	NAPROXEN SODIUM TABLET [MEDSOURCE PHARMACEUTICALS]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	NAPROXEN SODIUM TABLET [MEDSOURCE PHARMACEUTICALS]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NAPROXEN SODIUM TABLET [MEDSOURCE PHARMACEUTICALS]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN TABLET NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN SODIUM TABLET [BRYANT RANCH PREPACK]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN SODIUM TABLET [MEDSOURCE PHARMACEUTICALS]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	NAPROXEN SODIUM TABLET [MEDSOURCE PHARMACEUTICALS]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	NAPROXEN TABLET NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	NAPROXEN SODIUM TABLET [MEDSOURCE PHARMACEUTICALS]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	NAPROXEN SODIUM TABLET [BRYANT RANCH PREPACK]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NAPROXEN SODIUM TABLET [MEDSOURCE PHARMACEUTICALS]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NAPROXEN SODIUM TABLET [BRYANT RANCH PREPACK]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NAPROXEN TABLET NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NAPROXEN SODIUM TABLET [MEDSOURCE PHARMACEUTICALS]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NAPROXEN SODIUM TABLET [BRYANT RANCH PREPACK]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NAPROXEN SODIUM TABLET [MEDSOURCE PHARMACEUTICALS]	2
NAPROXEN	ACTIVE INGREDIENT	57Y76R9ATQ	NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.]	1
NAPROXEN SODIUM	ACTIVE INGREDIENT	9TN87S3A3C	NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.]	1
NAPROXEN SODIUM	ACTIVE INGREDIENT	9TN87S3A3C	NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]	1
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.]	1
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]	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 SODIUM TABLET [BLENHEIM PHARMACAL, INC.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NAPROXEN SODIUM TABLET [BLENHEIM PHARMACAL, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-178	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 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen Sodium	NAPROXEN SODIUM	Advanced Rx of Tennessee, LLC	36996557-3227-b753-e063-6394a90a7b6f	2026-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078314 application number: ANDA078314
Naproxen Sodium	NAPROXEN SODIUM	Bryant Ranch Prepack	83dd8829-7ba0-4a8d-a979-41a5e077c49f	2026-02-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078314 application number: ANDA078314
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): 078314 application number: ANDA078314 ndc (product): 68462-178

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9TN87S3A3C	NAPROXEN SODIUM	26159-34-2	NAPROXEN SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
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
849398	naproxen sodium 275 MG Oral Tablet	PSN	1ea7e83b-e28b-17f7-e054-00144ff8d46c	3
849398	naproxen sodium 275 MG Oral Tablet	PSN	577b9f26-ab59-4b15-a26a-465f0d255bad	3
849431	naproxen sodium 550 MG Oral Tablet	PSN	577b9f26-ab59-4b15-a26a-465f0d255bad	3
849398	naproxen sodium 275 MG Oral Tablet	SCD	577b9f26-ab59-4b15-a26a-465f0d255bad	3
849398	naproxen sodium 275 MG Oral Tablet	SCD	1ea7e83b-e28b-17f7-e054-00144ff8d46c	3
849431	naproxen sodium 550 MG Oral Tablet	SCD	577b9f26-ab59-4b15-a26a-465f0d255bad	3
849398	naproxen sodium 275 MG (as naproxen 250 MG) Oral Tablet	SY	1ea7e83b-e28b-17f7-e054-00144ff8d46c	3
849398	naproxen sodium 275 MG (as naproxen 250 MG) Oral Tablet	SY	577b9f26-ab59-4b15-a26a-465f0d255bad	3
849431	naproxen sodium 550 MG (as naproxen 500 MG) Oral Tablet	SY	577b9f26-ab59-4b15-a26a-465f0d255bad	3
198012	naproxen 375 MG Oral Tablet	PSN	50954ade-19ad-40dd-8e06-0b33394895f7	2
198014	naproxen 500 MG Oral Tablet	PSN	50954ade-19ad-40dd-8e06-0b33394895f7	2
849398	naproxen sodium 275 MG Oral Tablet	PSN	50954ade-19ad-40dd-8e06-0b33394895f7	2
849431	naproxen sodium 550 MG Oral Tablet	PSN	50954ade-19ad-40dd-8e06-0b33394895f7	2
198012	naproxen 375 MG Oral Tablet	SCD	50954ade-19ad-40dd-8e06-0b33394895f7	2
198014	naproxen 500 MG Oral Tablet	SCD	50954ade-19ad-40dd-8e06-0b33394895f7	2
849398	naproxen sodium 275 MG Oral Tablet	SCD	50954ade-19ad-40dd-8e06-0b33394895f7	2
849431	naproxen sodium 550 MG Oral Tablet	SCD	50954ade-19ad-40dd-8e06-0b33394895f7	2
849398	naproxen sodium 275 MG (as naproxen 250 MG) Oral Tablet	SY	50954ade-19ad-40dd-8e06-0b33394895f7	2
849431	naproxen sodium 550 MG (as naproxen 500 MG) Oral Tablet	SY	50954ade-19ad-40dd-8e06-0b33394895f7	2
198013	naproxen 250 MG Oral Tablet	PSN	4bbe6e74-b13e-4609-b4cc-aa0b00d66df8	1
198012	naproxen 375 MG Oral Tablet	PSN	4bbe6e74-b13e-4609-b4cc-aa0b00d66df8	1
198014	naproxen 500 MG Oral Tablet	PSN	4bbe6e74-b13e-4609-b4cc-aa0b00d66df8	1
849398	naproxen sodium 275 MG Oral Tablet	PSN	d32e840b-c984-4f74-8c0c-ad44fa7a4f36	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	4bbe6e74-b13e-4609-b4cc-aa0b00d66df8	1
198012	naproxen 375 MG Oral Tablet	SCD	4bbe6e74-b13e-4609-b4cc-aa0b00d66df8	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
849398	naproxen sodium 275 MG Oral Tablet	SCD	d32e840b-c984-4f74-8c0c-ad44fa7a4f36	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
849398	naproxen sodium 275 MG (as naproxen 250 MG) Oral Tablet	SY	d32e840b-c984-4f74-8c0c-ad44fa7a4f36	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
68462-178-01	68462017801	100 TABLET in 1 BOTTLE (68462-178-01)	100 tablet	2007-08-01	0000-00-00	No	No	Current
68462-178-05	68462017805	500 TABLET in 1 BOTTLE (68462-178-05)	500 tablet	2007-08-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Naproxen	Glenmark Pharmaceuticals Inc., USA \| Glenmark Pharmaceuticals Limited	2025-12-23	HUMAN PRESCRIPTION DRUG LABEL	13
Naproxen Sodium	Bryant Ranch Prepack	2020-10-16	HUMAN PRESCRIPTION DRUG LABEL	8
NAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP	Medsource Pharmaceuticals	2019-12-27	HUMAN PRESCRIPTION DRUG LABEL	3
NAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP	Blenheim Pharmacal, Inc.	2015-11-18	HUMAN PRESCRIPTION DRUG LABEL	1
Naproxen Tablets, USP Naproxen Sodium Tablets, USP	Physicians Total Care, Inc.	2012-09-11	HUMAN PRESCRIPTION DRUG LABEL	3
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	Blenheim Pharmacal, Inc.	2010-04-21	HUMAN PRESCRIPTION DRUG LABEL	2