NAPROXEN

Product NDC: 61919-586
11-digit product format: 619190586
Labeler code: 61919
Product ID: 61919-586_9ca985c6-503e-0558-e053-2995a90a8202
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: NAPROXEN
Dosage form: TABLET
Route: ORAL
Labeler: DirectRX
Application: ANDA091305
Marketing category: ANDA
Marketing start: 2015-01-01
Marketing end: 0000-00-00
Substance: NAPROXEN
Active strength: 500 mg/1
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61919-586		I	Inactivated by FDA	2026-08-17
excluded package	package	61919-586	61919-586-14	I	Inactivated by FDA	2026-08-17
excluded package	package	61919-586	61919-586-20	I	Inactivated by FDA	2026-08-17
excluded package	package	61919-586	61919-586-60	I	Inactivated by FDA	2026-08-17

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 · 64 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	61919-586-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-586-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-586-14	`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	61919-586-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-586-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-586-14	`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	61919-586-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-586-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-586-14	`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	61919-586-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-586-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-586-14	`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	61919-586-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-586-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-586-14	`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	61919-586-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-586-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-586-14	`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	61919-586-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-586-20	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-586-14	`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	61919-586-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-586-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-586-14	`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	61919-586-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-586-20	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-586-14	`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	61919-586-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61919-586-20	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61919-586-14	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61919-586-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61919-586-20	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61919-586-14	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61919-586-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61919-586-20	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61919-586-14	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61919-586-60	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61919-586-20	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61919-586-14	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61919-586-60	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61919-586-20	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61919-586-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61919-586-60	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61919-586-20	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61919-586-14	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	Approval date
A091305-001	NAPROXEN	NAPROXEN	250MG	TABLET / ORAL	2011-08-24
A091305-002	NAPROXEN	NAPROXEN	375MG	TABLET / ORAL	2011-08-24
A091305-003	NAPROXEN	NAPROXEN	500MG	TABLET / ORAL	2011-08-24

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 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A091305-001	NAPROXEN	250MG	TABLET / ORAL	2011-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091305-002	NAPROXEN	375MG	TABLET / ORAL	2011-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091305-003	NAPROXEN	500MG	TABLET / ORAL	2011-08-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091305-001	NAPROXEN	250MG	TABLET / ORAL	2011-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091305-002	NAPROXEN	375MG	TABLET / ORAL	2011-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091305-003	NAPROXEN	500MG	TABLET / ORAL	2011-08-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091305-001	NAPROXEN	250MG	TABLET / ORAL	2011-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091305-002	NAPROXEN	375MG	TABLET / ORAL	2011-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091305-003	NAPROXEN	500MG	TABLET / ORAL	2011-08-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091305-001	NAPROXEN	250MG	TABLET / ORAL	2011-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091305-002	NAPROXEN	375MG	TABLET / ORAL	2011-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091305-003	NAPROXEN	500MG	TABLET / ORAL	2011-08-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091305-001	NAPROXEN	250MG	TABLET / ORAL	2011-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091305-002	NAPROXEN	375MG	TABLET / ORAL	2011-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091305-003	NAPROXEN	500MG	TABLET / ORAL	2011-08-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091305-001	NAPROXEN	250MG	TABLET / ORAL	2011-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091305-002	NAPROXEN	375MG	TABLET / ORAL	2011-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091305-003	NAPROXEN	500MG	TABLET / ORAL	2011-08-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091305-001	NAPROXEN	250MG	TABLET / ORAL	2011-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091305-002	NAPROXEN	375MG	TABLET / ORAL	2011-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091305-003	NAPROXEN	500MG	TABLET / ORAL	2011-08-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091305-001	NAPROXEN	250MG	TABLET / ORAL	2011-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091305-002	NAPROXEN	375MG	TABLET / ORAL	2011-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091305-003	NAPROXEN	500MG	TABLET / ORAL	2011-08-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091305-001	NAPROXEN	250MG	TABLET / ORAL	2011-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091305-002	NAPROXEN	375MG	TABLET / ORAL	2011-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091305-003	NAPROXEN	500MG	TABLET / ORAL	2011-08-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091305-001	NAPROXEN	250MG	TABLET / ORAL	2011-08-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091305-002	NAPROXEN	375MG	TABLET / ORAL	2011-08-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091305-003	NAPROXEN	500MG	TABLET / ORAL	2011-08-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091305-001	NAPROXEN	250MG	TABLET / ORAL	2011-08-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091305-002	NAPROXEN	375MG	TABLET / ORAL	2011-08-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091305-003	NAPROXEN	500MG	TABLET / ORAL	2011-08-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091305-001	NAPROXEN	250MG	TABLET / ORAL	2011-08-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091305-002	NAPROXEN	375MG	TABLET / ORAL	2011-08-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091305-003	NAPROXEN	500MG	TABLET / ORAL	2011-08-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091305-001	NAPROXEN	250MG	TABLET / ORAL	2011-08-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091305-002	NAPROXEN	375MG	TABLET / ORAL	2011-08-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091305-003	NAPROXEN	500MG	TABLET / ORAL	2011-08-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091305-001	NAPROXEN	250MG	TABLET / ORAL	2011-08-24	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091305-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091305-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091305-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091305-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091305-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091305-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091305-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091305-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091305-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091305-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091305-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091305-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091305-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091305-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091305-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091305-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091305-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091305-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091305-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091305-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091305-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091305-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A091305-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A091305-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091305-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091305-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091305-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091305-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091305-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091305-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091305-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091305-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091305-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091305-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091305-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091305-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091305-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091305-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091305-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091305-001	AB	1	`6a51e52b5d6a…`

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, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61919-586-14	2023-01-30	C162847	48780-1	f386c64a-4659-0266-e053-dadaa90a7c1a	NAPROXEN
61919-586-20	2023-01-30	C162847	48780-1	f386c64a-4659-0266-e053-dadaa90a7c1a	NAPROXEN
61919-586-60	2023-01-30	C162847	48780-1	f386c64a-4659-0266-e053-dadaa90a7c1a	NAPROXEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61919-586-14	NAPROXEN	14 in 1 BOTTLE	TABLET	14	4
61919-586-20	NAPROXEN	20 in 1 BOTTLE	TABLET	20	4
61919-586-60	NAPROXEN	60 in 1 BOTTLE	TABLET	60	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-586-14	EA - Each	61919-586	746dc2b6-2b20-4075-9daf-db037797186e	1	2016-09-02
61919-586-20	EA - Each	61919-586	845f3df9-d837-4bd7-a578-9d3b5dac3d56	1	2016-09-02
61919-586-60	EA - Each	61919-586	2e23789a-8313-400c-bb94-a17ea4223d9d	1	2016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NAPROXEN	ACTIVE INGREDIENT	57Y76R9ATQ	NAPROXEN TABLET [DIRECTRX]	2
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN TABLET [DIRECTRX]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NAPROXEN TABLET [DIRECTRX]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	NAPROXEN TABLET [DIRECTRX]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN TABLET [DIRECTRX]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	NAPROXEN TABLET [DIRECTRX]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NAPROXEN TABLET [DIRECTRX]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-586	NAPROXEN TABLET [DIRECTRX]	4	Legacy NDC, 3 package rows	20200130_50c696da-0ea6-4d76-b50e-fb0b55ff77ae.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	NAPROXEN	Cipla USA Inc.	a9549a47-3fa4-4a2b-95ac-b00e43aedae7	2023-01-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091305 application number: ANDA091305
Naproxen	NAPROXEN	Exelan Pharmaceuticals, Inc.	46dbdb95-a0d0-4410-8d64-b22763b12af7	2020-08-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091305 application number: ANDA091305
Naproxen	NAPROXEN	Aphena Pharma Solutions - Tennessee, LLC	e2347581-90da-429a-b17c-cffd0039fb86	2017-10-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091305 application number: ANDA091305

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	50c696da-0ea6-4d76-b50e-fb0b55ff77ae	4
198014	naproxen 500 MG Oral Tablet	SCD	50c696da-0ea6-4d76-b50e-fb0b55ff77ae	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-586-14	61919058614	14 TABLET in 1 BOTTLE (61919-586-14)	14 tablet	2015-01-01	0000-00-00	No	No	Current
61919-586-20	61919058620	20 TABLET in 1 BOTTLE (61919-586-20)	20 tablet	2015-01-01	0000-00-00	No	No	Current
61919-586-60	61919058660	60 TABLET in 1 BOTTLE (61919-586-60)	60 tablet	2015-01-01	0000-00-00	No	No	Current