Naproxen

Product NDC: 63629-3795
11-digit product format: 636293795
Labeler code: 63629
Product ID: 63629-3795_862d4da9-d378-45b9-8c86-ba1b57c97c2b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naproxen
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA075227
Marketing category: ANDA
Marketing start: 1998-07-29
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: 2019-12-31
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 · 9 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63629-3795		D	Discontinued by firm	2026-08-17
excluded package	package	63629-3795	63629-3795-1	D	Discontinued by firm	2026-08-17
excluded package	package	63629-3795	63629-3795-2	D	Discontinued by firm	2026-08-17
excluded package	package	63629-3795	63629-3795-3	D	Discontinued by firm	2026-08-17
excluded package	package	63629-3795	63629-3795-4	D	Discontinued by firm	2026-08-17
excluded package	package	63629-3795	63629-3795-5	D	Discontinued by firm	2026-08-17
excluded package	package	63629-3795	63629-3795-6	D	Discontinued by firm	2026-08-17
excluded package	package	63629-3795	63629-3795-7	D	Discontinued by firm	2026-08-17
excluded package	package	63629-3795	63629-3795-8	D	Discontinued by firm	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 3 · 126 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	63629-3795-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-3795-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-3795-8	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-3795-7	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-3795-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-3795-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-3795-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-3795-3	`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	63629-3795-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-3795-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-3795-8	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-3795-7	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-3795-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-3795-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-3795-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-3795-3	`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	63629-3795-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-3795-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-3795-8	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-3795-7	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-3795-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-3795-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-3795-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-3795-3	`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	63629-3795-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-3795-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-3795-8	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-3795-7	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-3795-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-3795-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-3795-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-3795-3	`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	63629-3795-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-3795-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-3795-8	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-3795-7	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-3795-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-3795-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-3795-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-3795-3	`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	63629-3795-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-3795-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-3795-8	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-3795-7	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-3795-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-3795-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-3795-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-3795-3	`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	63629-3795-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-3795-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-3795-8	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-3795-7	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-3795-5	`302b2466d912…`	`e7b80fea0513…`

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
A075227-001	NAPROXEN	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB		1998-06-30
A075227-002	NAPROXEN	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB		1998-06-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075227-001	AB
A075227-002	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	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`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	A075227-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075227-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075227-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075227-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075227-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075227-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075227-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075227-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075227-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075227-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075227-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075227-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075227-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075227-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075227-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075227-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075227-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075227-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075227-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075227-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075227-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075227-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075227-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075227-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075227-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075227-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075227-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075227-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075227-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075227-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075227-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075227-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075227-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075227-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075227-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075227-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075227-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075227-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075227-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075227-002	AB	1	`bb7c543d1eb4…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-3795-1	2021-08-17	These highlights do not include all the information needed to use NAPROXEN DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for NAPROXEN DELAYED-RELEASE TABLETS. NAPROXEN delayed-release tablets, for oral use Initial U.S. Approval: 1976
63629-3795-2	2021-08-17	These highlights do not include all the information needed to use NAPROXEN DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for NAPROXEN DELAYED-RELEASE TABLETS. NAPROXEN delayed-release tablets, for oral use Initial U.S. Approval: 1976
63629-3795-3	2021-08-17	These highlights do not include all the information needed to use NAPROXEN DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for NAPROXEN DELAYED-RELEASE TABLETS. NAPROXEN delayed-release tablets, for oral use Initial U.S. Approval: 1976
63629-3795-4	2021-08-17	These highlights do not include all the information needed to use NAPROXEN DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for NAPROXEN DELAYED-RELEASE TABLETS. NAPROXEN delayed-release tablets, for oral use Initial U.S. Approval: 1976
63629-3795-5	2021-08-17	These highlights do not include all the information needed to use NAPROXEN DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for NAPROXEN DELAYED-RELEASE TABLETS. NAPROXEN delayed-release tablets, for oral use Initial U.S. Approval: 1976
63629-3795-6	2021-08-17	These highlights do not include all the information needed to use NAPROXEN DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for NAPROXEN DELAYED-RELEASE TABLETS. NAPROXEN delayed-release tablets, for oral use Initial U.S. Approval: 1976
63629-3795-7	2021-08-17	These highlights do not include all the information needed to use NAPROXEN DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for NAPROXEN DELAYED-RELEASE TABLETS. NAPROXEN delayed-release tablets, for oral use Initial U.S. Approval: 1976
63629-3795-8	2021-08-17	These highlights do not include all the information needed to use NAPROXEN DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for NAPROXEN DELAYED-RELEASE TABLETS. NAPROXEN delayed-release tablets, for oral use Initial U.S. Approval: 1976
63629-3795-1	2020-01-31	These highlights do not include all the information needed to use NAPROXEN DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for NAPROXEN DELAYED-RELEASE TABLETS. NAPROXEN delayed-release tablets, for oral use Initial U.S. Approval: 1976
63629-3795-2	2020-01-31	These highlights do not include all the information needed to use NAPROXEN DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for NAPROXEN DELAYED-RELEASE TABLETS. NAPROXEN delayed-release tablets, for oral use Initial U.S. Approval: 1976
63629-3795-3	2020-01-31	These highlights do not include all the information needed to use NAPROXEN DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for NAPROXEN DELAYED-RELEASE TABLETS. NAPROXEN delayed-release tablets, for oral use Initial U.S. Approval: 1976
63629-3795-4	2020-01-31	These highlights do not include all the information needed to use NAPROXEN DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for NAPROXEN DELAYED-RELEASE TABLETS. NAPROXEN delayed-release tablets, for oral use Initial U.S. Approval: 1976
63629-3795-5	2020-01-31	These highlights do not include all the information needed to use NAPROXEN DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for NAPROXEN DELAYED-RELEASE TABLETS. NAPROXEN delayed-release tablets, for oral use Initial U.S. Approval: 1976
63629-3795-6	2020-01-31	These highlights do not include all the information needed to use NAPROXEN DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for NAPROXEN DELAYED-RELEASE TABLETS. NAPROXEN delayed-release tablets, for oral use Initial U.S. Approval: 1976
63629-3795-7	2020-01-31	These highlights do not include all the information needed to use NAPROXEN DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for NAPROXEN DELAYED-RELEASE TABLETS. NAPROXEN delayed-release tablets, for oral use Initial U.S. Approval: 1976
63629-3795-8	2020-01-31	These highlights do not include all the information needed to use NAPROXEN DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for NAPROXEN DELAYED-RELEASE TABLETS. NAPROXEN delayed-release tablets, for oral use Initial U.S. Approval: 1976

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-3795-1	EA - Each	63629-3795	2990ff98-b340-482c-b49c-9d09ef56756f	1	2012-07-24
63629-3795-2	EA - Each	63629-3795	45366190-e524-4faf-a284-5ed797346da4	1	2012-07-24
63629-3795-3	EA - Each	63629-3795	3806aa5a-cb11-4e4d-85d6-fcd0c3cee755	1	2012-07-24
63629-3795-4	EA - Each	63629-3795	ae1837b5-3480-4fcd-b7f4-e1598b2d2c0a	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NAPROXEN	ACTIVE INGREDIENT	57Y76R9ATQ	NAPROXEN TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]	2
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NAPROXEN TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	NAPROXEN TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]	2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	NAPROXEN TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	NAPROXEN TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NAPROXEN TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NAPROXEN TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NAPROXEN TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]	2
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	NAPROXEN TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]	2