NAPROXEN

Product NDC: 61919-204
11-digit product format: 619190204
Labeler code: 61919
Product ID: 61919-204_eac6245a-d2fa-5f81-e053-2995a90a41e0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: NAPROXEN
Dosage form: TABLET
Route: ORAL
Labeler: DIRECT RX
Application: ANDA075927
Marketing category: ANDA
Marketing start: 2017-05-22
Marketing end: 0000-00-00
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: 2023-12-31
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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61919-204		I	Inactivated by FDA	2026-10-05
excluded package	package	61919-204	61919-204-14	I	Inactivated by FDA	2026-10-05
excluded package	package	61919-204	61919-204-20	I	Inactivated by FDA	2026-10-05
excluded package	package	61919-204	61919-204-28	I	Inactivated by FDA	2026-10-05
excluded package	package	61919-204	61919-204-30	I	Inactivated by FDA	2026-10-05
excluded package	package	61919-204	61919-204-60	I	Inactivated by FDA	2026-10-05
excluded package	package	61919-204	61919-204-90	I	Inactivated by FDA	2026-10-05

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 2 · 67 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-204-28	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-204-90	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-204-30	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-204-60	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-204-20	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-204-14	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-204-28	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-204-90	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-204-30	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-204-60	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-204-20	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-204-14	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-204-28	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-204-90	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-204-30	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-204-60	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-204-20	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-204-14	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-204-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-204-90	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-204-30	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-204-60	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-204-20	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-204-14	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-204-28	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-204-90	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-204-30	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-204-60	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-204-20	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-204-14	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-204-28	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-204-90	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-204-30	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-204-60	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-204-20	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-204-14	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-204-28	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-204-20	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-204-60	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-204-30	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-204-14	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-204-90	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-204-28	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-204-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-204-60	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-204-30	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-204-14	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-204-90	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-204-28	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-204-20	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-204-60	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 129 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
2026-09-14 22:38:34	2026-08	A075927-001	NAPROXEN	250MG	TABLET / ORAL	AB	2001-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075927-002	NAPROXEN	375MG	TABLET / ORAL	AB	2001-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075927-003	NAPROXEN	500MG	TABLET / ORAL	AB	2001-12-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075927-001	NAPROXEN	250MG	TABLET / ORAL	AB	2001-12-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075927-002	NAPROXEN	375MG	TABLET / ORAL	AB	2001-12-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075927-003	NAPROXEN	500MG	TABLET / ORAL	AB	2001-12-18	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A075927-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075927-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075927-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075927-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075927-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075927-003	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
61919-204-14	NAPROXEN
61919-204-20	NAPROXEN
61919-204-28	NAPROXEN
61919-204-30	NAPROXEN
61919-204-60	NAPROXEN
61919-204-90	NAPROXEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61919-204-14	NAPROXEN	14 in 1 BOTTLE	TABLET	14	7
61919-204-20	NAPROXEN	20 in 1 BOTTLE	TABLET	20	7
61919-204-28	NAPROXEN	28 in 1 BOTTLE	TABLET	28	7
61919-204-30	NAPROXEN	30 in 1 BOTTLE	TABLET	30	7
61919-204-60	NAPROXEN	60 in 1 BOTTLE	TABLET	60	7
61919-204-90	NAPROXEN	90 in 1 BOTTLE	TABLET	90	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-204-14	EA - Each	61919-204	67df4128-30c6-48a8-b2d4-09f6df3a4032	1	2023-03-13
61919-204-20	EA - Each	61919-204	23670ca8-0e7e-4bf3-b9e9-d08eec130be4	1	2023-04-07
61919-204-28	EA - Each	61919-204	6e6344b9-a692-4c9d-b041-69dcb15ca8c6	1	2023-04-07
61919-204-30	EA - Each	61919-204	8059a643-e23a-4493-9731-3a9b80e8f698	1	2017-07-07
61919-204-60	EA - Each	61919-204	ce3c1b17-ae9e-4619-a4a2-6d7c155c82c7	1	2017-07-07
61919-204-90	EA - Each	61919-204	a1510b7b-98f1-4fe9-b7f0-b00e9ec9742d	1	2023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-204	NAPROXEN TABLET [DIRECT RX]	7	Legacy NDC, 6 package rows	20230414_50217b0f-a696-6c82-e054-00144ff88e88.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
198014	naproxen 500 MG Oral Tablet	PSN	50217b0f-a696-6c82-e054-00144ff88e88	7
198014	naproxen 500 MG Oral Tablet	SCD	50217b0f-a696-6c82-e054-00144ff88e88	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-204-14	61919020414	14 TABLET in 1 BOTTLE (61919-204-14)	14 tablet	2017-05-22	0000-00-00	No	No	Current
61919-204-20	61919020420	20 TABLET in 1 BOTTLE (61919-204-20)	20 tablet	2017-05-22	0000-00-00	No	No	Current
61919-204-28	61919020428	28 in 1 BOTTLE						Historical
61919-204-30	61919020430	30 TABLET in 1 BOTTLE (61919-204-30)	30 tablet	2017-05-22	0000-00-00	No	No	Current
61919-204-60	61919020460	60 TABLET in 1 BOTTLE (61919-204-60)	60 tablet	2017-05-22	0000-00-00	No	No	Current
61919-204-90	61919020490	90 TABLET in 1 BOTTLE (61919-204-90)	90 tablet	2017-05-22	0000-00-00	No	No	Current