Naproxen

Product NDC: 21695-085
11-digit product format: 216950085
Labeler code: 21695
Product ID: 21695-085_a04bcc67-1f1a-4669-bb69-77738a939944
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naproxen
Dosage form: TABLET
Route: ORAL
Labeler: Rebel Distributors Corp.
Application: ANDA075927
Marketing category: ANDA
Marketing start: 2010-02-18
Marketing end: 0000-00-00
Substance: NAPROXEN
Active strength: 375 mg/1
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

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

Current NDC status page 1 of 1 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	21695-085		I	Inactivated by FDA	2026-08-10
excluded package	package	21695-085	21695-085-20	I	Inactivated by FDA	2026-08-10
excluded package	package	21695-085	21695-085-30	I	Inactivated by FDA	2026-08-10
excluded package	package	21695-085	21695-085-60	I	Inactivated by FDA	2026-08-10
excluded package	package	21695-085	21695-085-72	I	Inactivated by FDA	2026-08-10
excluded package	package	21695-085	21695-085-90	I	Inactivated by FDA	2026-08-10

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 3 · 132 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-085-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-085-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-085-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-085-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-085-72	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-085-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-085-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-085-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-085-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-085-72	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-085-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-085-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-085-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-085-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-085-72	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-085-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-085-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-085-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-085-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-085-72	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-085-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-085-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-085-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-085-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-085-72	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-085-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-085-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-085-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-085-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-085-72	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-085-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-085-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-085-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-085-20	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-085-72	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-085-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-085-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-085-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-085-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-085-72	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-085-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-085-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-085-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-085-20	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-085-72	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-085-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-085-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-085-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-085-20	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-085-72	`ad56d346431e…`	`cc804d4bbf1e…`

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
A075927-001	NAPROXEN	NAPROXEN	250MG	TABLET / ORAL	AB	2001-12-18
A075927-002	NAPROXEN	NAPROXEN	375MG	TABLET / ORAL	AB	2001-12-18
A075927-003	NAPROXEN	NAPROXEN	500MG	TABLET / ORAL	AB	2001-12-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075927-001	AB
A075927-002	AB
A075927-003	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	A075927-001	NAPROXEN	250MG	TABLET / ORAL	AB	2001-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075927-002	NAPROXEN	375MG	TABLET / ORAL	AB	2001-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075927-003	NAPROXEN	500MG	TABLET / ORAL	AB	2001-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075927-001	NAPROXEN	250MG	TABLET / ORAL	AB	2001-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075927-002	NAPROXEN	375MG	TABLET / ORAL	AB	2001-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075927-003	NAPROXEN	500MG	TABLET / ORAL	AB	2001-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075927-001	NAPROXEN	250MG	TABLET / ORAL	AB	2001-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075927-002	NAPROXEN	375MG	TABLET / ORAL	AB	2001-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075927-003	NAPROXEN	500MG	TABLET / ORAL	AB	2001-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075927-001	NAPROXEN	250MG	TABLET / ORAL	AB	2001-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075927-002	NAPROXEN	375MG	TABLET / ORAL	AB	2001-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075927-003	NAPROXEN	500MG	TABLET / ORAL	AB	2001-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075927-001	NAPROXEN	250MG	TABLET / ORAL	AB	2001-12-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075927-002	NAPROXEN	375MG	TABLET / ORAL	AB	2001-12-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075927-003	NAPROXEN	500MG	TABLET / ORAL	AB	2001-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075927-001	NAPROXEN	250MG	TABLET / ORAL	AB	2001-12-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075927-002	NAPROXEN	375MG	TABLET / ORAL	AB	2001-12-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075927-003	NAPROXEN	500MG	TABLET / ORAL	AB	2001-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075927-001	NAPROXEN	250MG	TABLET / ORAL	AB	2001-12-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075927-002	NAPROXEN	375MG	TABLET / ORAL	AB	2001-12-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075927-003	NAPROXEN	500MG	TABLET / ORAL	AB	2001-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075927-001	NAPROXEN	250MG	TABLET / ORAL	AB	2001-12-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075927-002	NAPROXEN	375MG	TABLET / ORAL	AB	2001-12-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075927-003	NAPROXEN	500MG	TABLET / ORAL	AB	2001-12-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075927-001	NAPROXEN	250MG	TABLET / ORAL	AB	2001-12-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075927-002	NAPROXEN	375MG	TABLET / ORAL	AB	2001-12-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075927-003	NAPROXEN	500MG	TABLET / ORAL	AB	2001-12-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075927-001	NAPROXEN	250MG	TABLET / ORAL	AB	2001-12-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075927-002	NAPROXEN	375MG	TABLET / ORAL	AB	2001-12-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075927-003	NAPROXEN	500MG	TABLET / ORAL	AB	2001-12-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075927-001	NAPROXEN	250MG	TABLET / ORAL	AB	2001-12-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075927-002	NAPROXEN	375MG	TABLET / ORAL	AB	2001-12-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075927-003	NAPROXEN	500MG	TABLET / ORAL	AB	2001-12-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075927-001	NAPROXEN	250MG	TABLET / ORAL	AB	2001-12-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075927-002	NAPROXEN	375MG	TABLET / ORAL	AB	2001-12-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075927-003	NAPROXEN	500MG	TABLET / ORAL	AB	2001-12-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075927-001	NAPROXEN	250MG	TABLET / ORAL	AB	2001-12-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075927-002	NAPROXEN	375MG	TABLET / ORAL	AB	2001-12-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075927-003	NAPROXEN	500MG	TABLET / ORAL	AB	2001-12-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075927-001	NAPROXEN	250MG	TABLET / ORAL	AB	2001-12-18	`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	A075927-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075927-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075927-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075927-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075927-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075927-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075927-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075927-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075927-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075927-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075927-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075927-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075927-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075927-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075927-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075927-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075927-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075927-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075927-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075927-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075927-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075927-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075927-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075927-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075927-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075927-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075927-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075927-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075927-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075927-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075927-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075927-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075927-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075927-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075927-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075927-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075927-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075927-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075927-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075927-001	AB	1	`8072bd15b7f6…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
21695-085-20	Naproxen Tablets, USP
21695-085-30	Naproxen Tablets, USP
21695-085-60	Naproxen Tablets, USP
21695-085-72	Naproxen Tablets, USP
21695-085-90	Naproxen Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
21695-085-20	Naproxen	20 in 1 BOTTLE	TABLET	20	3
21695-085-30	Naproxen	30 in 1 BOTTLE	TABLET	30	3
21695-085-60	Naproxen	60 in 1 BOTTLE	TABLET	60	3
21695-085-72	Naproxen	120 in 1 BOTTLE	TABLET	120	3
21695-085-90	Naproxen	90 in 1 BOTTLE	TABLET	90	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-085-20	EA - Each	21695-085	60648a63-2252-4a9c-a305-8573e8888460	1	2012-07-24
21695-085-30	EA - Each	21695-085	66316fea-7f03-40c1-aabb-40462b52d19e	1	2012-07-24
21695-085-60	EA - Each	21695-085	be9dd415-90a2-4ce5-9758-ae92de39ede0	1	2012-07-24
21695-085-72	EA - Each	21695-085	a65f9494-93a3-4213-bd31-157a53dbcf81	1	2012-07-24
21695-085-90	EA - Each	21695-085	9b502e71-8e45-445b-95cf-0f6812e95f32	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NAPROXEN	ACTIVE INGREDIENT	57Y76R9ATQ	NAPROXEN TABLET [REBEL DISTRIBUTORS CORP.]	3
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN TABLET [REBEL DISTRIBUTORS CORP.]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NAPROXEN TABLET [REBEL DISTRIBUTORS CORP.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN TABLET [REBEL DISTRIBUTORS CORP.]	3
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	NAPROXEN TABLET [REBEL DISTRIBUTORS CORP.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-085	NAPROXEN TABLET [REBEL DISTRIBUTORS CORP.]	3	Legacy NDC, 5 package rows	20111108_8c7b265e-7500-464a-854e-9c4a22c8d211.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen	NAPROXEN	Preferred Pharmaceuticals Inc.	c5e52ddd-a909-487a-bb46-01ad35690665	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075927 application number: ANDA075927
Naproxen	NAPROXEN	A-S Medication Solutions	c5c8b6fd-f3f5-4fed-823c-9a80386b27b1	2026-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075927 application number: ANDA075927
Naproxen	NAPROXEN	AvPAK	e6fbf8f1-b064-658d-17bb-e7d6320aa45f	2026-03-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075927 application number: ANDA075927
Naproxen	NAPROXEN	Northwind Health Company, LLC	ab6ec2c9-5df9-346c-e053-2a95a90ac81d	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075927 application number: ANDA075927
Naproxen	NAPROXEN	QPharma, Inc.	307aa67f-53b9-4c60-a328-091bbf6338d4	2025-12-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075927 application number: ANDA075927
Naproxen	NAPROXEN	PD-Rx Pharmaceuticals, Inc.	29d98cf3-a0f2-3f89-e054-00144ff88e88	2025-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075927 application number: ANDA075927
Naproxen	NAPROXEN	PD-Rx Pharmaceuticals, Inc.	6573681e-e9be-440f-a818-a533b744648e	2025-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075927 application number: ANDA075927
Naproxen	NAPROXEN	Amneal Pharmaceuticals LLC	c43a43e2-e867-448d-8f59-3efc7c077cbc	2025-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075927 application number: ANDA075927
Naproxen	NAPROXEN	Bryant Ranch Prepack	9d7bc470-fbba-40a6-a56c-f681a3cee9cf	2025-03-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075927 application number: ANDA075927
Naproxen	NAPROXEN	Amneal Pharmaceuticals of New York LLC	2718e0b7-1ce6-457e-bee9-11b634dfd353	2025-03-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075927 application number: ANDA075927
Naproxen	NAPROXEN	Advanced Rx of Tennessee, LLC	af9ad850-57b5-a21d-e053-2a95a90ae68e	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075927 application number: ANDA075927
Naproxen	NAPROXEN	Advanced Rx of Tennessee, LLC	af9a94a8-3825-eabd-e053-2a95a90acd58	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075927 application number: ANDA075927
Naproxen	NAPROXEN	Bryant Ranch Prepack	a4f31070-4ee1-4d64-8b1d-40b9011e124b	2024-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075927 application number: ANDA075927
Naproxen	NAPROXEN	A-S Medication Solutions	80233fa5-f8b4-42d5-a8c9-4a1d8fd4aba4	2023-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075927 application number: ANDA075927
Naproxen	NAPROXEN	A-S Medication Solutions	21930f73-d3c2-4462-a487-74ed871b74b2	2023-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075927 application number: ANDA075927
Naproxen	NAPROXEN	A-S Medication Solutions	a5ea3a84-7acd-4f24-9f0f-9f871ce1b5f4	2023-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075927 application number: ANDA075927
Naproxen	NAPROXEN	Proficient Rx LP	fc3ee94a-adb7-411e-a662-2f2c6ddbabaf	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075927 application number: ANDA075927
Naproxen	NAPROXEN	NCS HealthCare of KY, Inc dba Vangard Labs	62a12771-bde9-4bc3-9ce9-672c8e31f020	2017-10-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075927 application number: ANDA075927

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	8c7b265e-7500-464a-854e-9c4a22c8d211	3
198012	naproxen 375 MG Oral Tablet	PSN	8c7b265e-7500-464a-854e-9c4a22c8d211	3
198014	naproxen 500 MG Oral Tablet	PSN	8c7b265e-7500-464a-854e-9c4a22c8d211	3
198013	naproxen 250 MG Oral Tablet	SCD	8c7b265e-7500-464a-854e-9c4a22c8d211	3
198012	naproxen 375 MG Oral Tablet	SCD	8c7b265e-7500-464a-854e-9c4a22c8d211	3
198014	naproxen 500 MG Oral Tablet	SCD	8c7b265e-7500-464a-854e-9c4a22c8d211	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-085-20	21695008520	20 in 1 BOTTLE	Historical
21695-085-30	21695008530	30 in 1 BOTTLE	Historical
21695-085-60	21695008560	60 in 1 BOTTLE	Historical
21695-085-72	21695008572	120 in 1 BOTTLE	Historical
21695-085-90	21695008590	90 in 1 BOTTLE	Historical