NAPROXEN

Product NDC: 52959-193
11-digit product format: 529590193
Labeler code: 52959
Product ID: 52959-193_65944dbd-d444-76d3-e053-2a91aa0ae69f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: NAPROXEN
Dosage form: TABLET
Route: ORAL
Labeler: H.J. Harkins Company., Inc.
Application: ANDA091416
Marketing category: ANDA
Marketing start: 2018-01-02
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 · 13 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	52959-193		I	Inactivated by FDA	2026-08-17
excluded package	package	52959-193	52959-193-00	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-193	52959-193-02	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-193	52959-193-06	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-193	52959-193-14	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-193	52959-193-20	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-193	52959-193-21	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-193	52959-193-28	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-193	52959-193-30	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-193	52959-193-40	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-193	52959-193-45	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-193	52959-193-60	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-193	52959-193-90	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 4 · 183 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	52959-193-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-193-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-193-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-193-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-193-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-193-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-193-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-193-21	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-193-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-193-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-193-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-193-30	`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	52959-193-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-193-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-193-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-193-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-193-45	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-193-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-193-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-193-21	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-193-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-193-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-193-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-193-30	`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	52959-193-00	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-193-40	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-193-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-193-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-193-45	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-193-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-193-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-193-21	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-193-28	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-193-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-193-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-193-30	`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	52959-193-00	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-193-40	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-193-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-193-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-193-45	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-193-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-193-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-193-21	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-193-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-193-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-193-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-193-30	`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	52959-193-00	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-193-40	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-193-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-193-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-193-45	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-193-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-193-60	`cfe11265f3b6…`	`090c488252e2…`

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	TE codes	Approval date
A091416-001	NAPROXEN	NAPROXEN	250MG	TABLET / ORAL	AB	2011-02-14
A091416-002	NAPROXEN	NAPROXEN	375MG	TABLET / ORAL	AB	2011-02-14
A091416-003	NAPROXEN	NAPROXEN	500MG	TABLET / ORAL	AB	2011-02-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091416-001	AB
A091416-002	AB
A091416-003	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 · 126 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	A091416-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-02-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091416-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-02-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091416-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-02-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091416-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091416-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091416-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-02-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091416-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091416-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091416-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-02-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091416-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-02-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091416-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-02-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091416-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-02-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091416-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-02-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091416-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-02-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091416-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-02-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091416-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-02-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091416-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-02-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091416-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-02-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091416-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-02-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091416-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-02-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091416-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-02-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091416-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-02-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091416-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-02-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091416-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-02-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091416-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-02-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091416-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-02-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091416-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-02-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091416-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-02-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091416-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-02-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091416-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-02-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091416-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-02-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091416-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-02-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091416-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-02-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091416-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-02-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091416-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-02-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091416-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-02-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091416-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-02-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091416-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-02-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091416-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-02-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091416-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-02-14	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A091416-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091416-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091416-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091416-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091416-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091416-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091416-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091416-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091416-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091416-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091416-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091416-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091416-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091416-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091416-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091416-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091416-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091416-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091416-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091416-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091416-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091416-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091416-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091416-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091416-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091416-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091416-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091416-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091416-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091416-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091416-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091416-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091416-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091416-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091416-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091416-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091416-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091416-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091416-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091416-001	AB	1	`1e350fbaab3a…`

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, Related label table
NDC	Effective	Related label
52959-193-00	2025-01-30	65944dbd-d443-76d3-e053-2a91aa0ae69f
52959-193-02	2025-01-30	65944dbd-d443-76d3-e053-2a91aa0ae69f
52959-193-06	2025-01-30	65944dbd-d443-76d3-e053-2a91aa0ae69f
52959-193-14	2025-01-30	65944dbd-d443-76d3-e053-2a91aa0ae69f
52959-193-20	2025-01-30	65944dbd-d443-76d3-e053-2a91aa0ae69f
52959-193-21	2025-01-30	65944dbd-d443-76d3-e053-2a91aa0ae69f
52959-193-28	2025-01-30	65944dbd-d443-76d3-e053-2a91aa0ae69f
52959-193-30	2025-01-30	65944dbd-d443-76d3-e053-2a91aa0ae69f
52959-193-40	2025-01-30	65944dbd-d443-76d3-e053-2a91aa0ae69f
52959-193-45	2025-01-30	65944dbd-d443-76d3-e053-2a91aa0ae69f
52959-193-60	2025-01-30	65944dbd-d443-76d3-e053-2a91aa0ae69f
52959-193-90	2025-01-30	65944dbd-d443-76d3-e053-2a91aa0ae69f
52959-193-00	2023-01-26	65944dbd-d443-76d3-e053-2a91aa0ae69f
52959-193-02	2023-01-26	65944dbd-d443-76d3-e053-2a91aa0ae69f
52959-193-06	2023-01-26	65944dbd-d443-76d3-e053-2a91aa0ae69f
52959-193-20	2023-01-26	65944dbd-d443-76d3-e053-2a91aa0ae69f
52959-193-21	2023-01-26	65944dbd-d443-76d3-e053-2a91aa0ae69f
52959-193-28	2023-01-26	65944dbd-d443-76d3-e053-2a91aa0ae69f
52959-193-40	2023-01-26	65944dbd-d443-76d3-e053-2a91aa0ae69f
52959-193-45	2023-01-26	65944dbd-d443-76d3-e053-2a91aa0ae69f
52959-193-60	2023-01-26	65944dbd-d443-76d3-e053-2a91aa0ae69f
52959-193-90	2023-01-26	65944dbd-d443-76d3-e053-2a91aa0ae69f
52959-193-00	2020-01-31	65944dbd-d443-76d3-e053-2a91aa0ae69f
52959-193-02	2020-01-31	65944dbd-d443-76d3-e053-2a91aa0ae69f
52959-193-06	2020-01-31	65944dbd-d443-76d3-e053-2a91aa0ae69f
52959-193-20	2020-01-31	65944dbd-d443-76d3-e053-2a91aa0ae69f
52959-193-21	2020-01-31	65944dbd-d443-76d3-e053-2a91aa0ae69f
52959-193-28	2020-01-31	65944dbd-d443-76d3-e053-2a91aa0ae69f
52959-193-40	2020-01-31	65944dbd-d443-76d3-e053-2a91aa0ae69f
52959-193-45	2020-01-31	65944dbd-d443-76d3-e053-2a91aa0ae69f
52959-193-60	2020-01-31	65944dbd-d443-76d3-e053-2a91aa0ae69f
52959-193-90	2020-01-31	65944dbd-d443-76d3-e053-2a91aa0ae69f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52959-193-30	Theraproxen-500	30 in 1 BOTTLE	TABLET	30	500 mg	8
52959-193-00	NAPROXEN	100 in 1 CONTAINER	TABLET	100		2
52959-193-02	NAPROXEN	120 in 1 CONTAINER	TABLET	120		2
52959-193-06	NAPROXEN	6 in 1 CONTAINER	TABLET	6		2
52959-193-14	NAPROXEN	14 in 1 CONTAINER	TABLET	14		2
52959-193-20	NAPROXEN	20 in 1 CONTAINER	TABLET	20		2
52959-193-21	NAPROXEN	21 in 1 CONTAINER	TABLET	21		2
52959-193-28	NAPROXEN	28 in 1 CONTAINER	TABLET	28		2
52959-193-30	NAPROXEN	30 in 1 CONTAINER	TABLET	30		2
52959-193-40	NAPROXEN	40 in 1 CONTAINER	TABLET	40		2
52959-193-45	NAPROXEN	45 in 1 CONTAINER	TABLET	45		2
52959-193-60	NAPROXEN	60 in 1 CONTAINER	TABLET	60		2
52959-193-90	NAPROXEN	90 in 1 CONTAINER	TABLET	90		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52959-193-00	EA - Each	52959-193	a4c04111-bf94-40e7-ad19-8add533218fd	1	2018-04-19
52959-193-02	EA - Each	52959-193	6ef194b4-78bd-4bea-88cf-d40907aecf5d	1	2018-04-19
52959-193-14	EA - Each	52959-193	6eefe8b0-fbb4-4cc3-bf04-df834c58340e	1	2023-02-06
52959-193-20	EA - Each	52959-193	df211312-c6a1-4e70-8b8a-09fbdeebe2cd	1	2018-04-19
52959-193-21	EA - Each	52959-193	b109084c-36fa-417e-8301-5584f2eb0321	1	2018-04-19
52959-193-28	EA - Each	52959-193	5ee5e342-6be7-4eef-9e50-18688d2f9033	1	2018-04-19
52959-193-30	EA - Each	52959-193	f53c4897-8bc7-494a-8682-0929fc3faafd	1	2023-02-06
52959-193-40	EA - Each	52959-193	3d7f1844-ff08-47c8-9bea-b33cdeb46cc2	1	2018-04-19
52959-193-60	EA - Each	52959-193	886da928-c576-4302-869d-8b8f294513c6	1	2018-04-19
52959-193-90	EA - Each	52959-193	3590c087-3f53-4544-9333-c413c1ccb26e	1	2018-04-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
.GAMMA.-AMINOBUTYRIC ACID	ACTIVE INGREDIENT	2ACZ6IPC6I	THERAPROXEN-500 (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	8
NAPROXEN	ACTIVE INGREDIENT	57Y76R9ATQ	THERAPROXEN-500 (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	8
.GAMMA.-AMINOBUTYRIC ACID	ACTIVE MOIETY	2ACZ6IPC6I	THERAPROXEN-500 (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	8
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	THERAPROXEN-500 (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	THERAPROXEN-500 (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	8
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	THERAPROXEN-500 (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	8
GELATIN	INACTIVE INGREDIENT	2G86QN327L	THERAPROXEN-500 (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	THERAPROXEN-500 (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	8
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	THERAPROXEN-500 (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	8
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	THERAPROXEN-500 (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-193	THERAPROXEN-500 (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	8	Legacy NDC	20110812_701b69d8-cce8-42de-a770-96020c1a870a.zip
52959-193	NAPROXEN TABLET [H.J. HARKINS COMPANY., INC.]	2	Legacy NDC, 12 package rows	20230127_65944dbd-d443-76d3-e053-2a91aa0ae69f.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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NAPROXEN	NAPROXEN	Northwind Health Company, LLC	f32d755e-4984-ee40-e053-2995a90a4ebe	2026-01-01	Warnings	Exact identifier application applno (ANDA): 091416 application number: ANDA091416
NAPROXEN	NAPROXEN	QPharma Inc	c0a4839b-7154-c82c-e053-2a95a90a7e6d	2025-12-03	Warnings	Exact identifier application applno (ANDA): 091416 application number: ANDA091416
NAPROXEN	NAPROXEN	PD-Rx Pharmaceuticals, Inc.	a9f9ce81-9d51-4167-9581-974866a8fe31	2025-10-17	Warnings	Exact identifier application applno (ANDA): 091416 application number: ANDA091416
NAPROXEN	NAPROXEN	DIRECT RX	b1b78c49-82e9-2402-e053-2a95a90ae35f	2025-01-17	Warnings	Exact identifier application applno (ANDA): 091416 application number: ANDA091416
Naproxen	NAPROXEN	Advanced Rx of Tennessee, LLC	af9a96cf-1cda-8ace-e053-2a95a90a18cc	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091416 application number: ANDA091416
Naproxen	NAPROXEN	MARKSANS PHARMA LIMITED	1fdb4cbd-e9e8-47bb-b3d8-1f1ec8f411c8	2024-12-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091416 application number: ANDA091416
NAPROXEN	NAPROXEN	NuCare Pharmaceuticals,Inc.	5487dee2-5c37-4348-e054-00144ff8d46c	2024-07-17	Warnings	Exact identifier application applno (ANDA): 091416 application number: ANDA091416
NAPROXEN	NAPROXEN	NuCare Pharmaceuticals,Inc.	71d4a048-ca50-73db-e053-2a95a90ad465	2024-06-10	Warnings	Exact identifier application applno (ANDA): 091416 application number: ANDA091416
NAPROXEN	NAPROXEN	NuCare Pharmaceuticals,Inc.	69366b55-2687-17a4-e053-2a91aa0a65b3	2024-06-07		Exact identifier application applno (ANDA): 091416 application number: ANDA091416
NAPROXEN	NAPROXEN	Asclemed USA, Inc.	a4fcb411-c918-459b-adc6-06dfa8ed8a50	2022-10-12	Warnings	Exact identifier application applno (ANDA): 091416 application number: ANDA091416
NAPROXEN	NAPROXEN	Aphena Pharma Solutions - Tennessee, LLC	32693390-763b-46dd-b821-65a7bf3c6671	2021-04-26	Warnings	Exact identifier application applno (ANDA): 091416 application number: ANDA091416
NAPROXEN	NAPROXEN	Bryant Ranch Prepack	5d399bf3-db49-411a-91b9-b410d702a65a	2020-12-14	Warnings	Exact identifier application applno (ANDA): 091416 application number: ANDA091416
NAPROXEN	NAPROXEN	TIME CAP LABORATORIES	4350a2d9-5228-460e-b7b1-27e8fa846787	2018-10-09	Warnings	Exact identifier application applno (ANDA): 091416 application number: ANDA091416

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	701b69d8-cce8-42de-a770-96020c1a870a	8
198014	naproxen 500 MG Oral Tablet	SCD	701b69d8-cce8-42de-a770-96020c1a870a	8
198014	naproxen 500 MG Oral Tablet	PSN	65944dbd-d443-76d3-e053-2a91aa0ae69f	2
198014	naproxen 500 MG Oral Tablet	SCD	65944dbd-d443-76d3-e053-2a91aa0ae69f	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
52959-193-00	52959019300	100 in 1 CONTAINER	Historical
52959-193-02	52959019302	120 in 1 CONTAINER	Historical
52959-193-06	52959019306	6 in 1 CONTAINER	Historical
52959-193-14	52959019314	14 in 1 CONTAINER	Historical
52959-193-20	52959019320	20 in 1 CONTAINER	Historical
52959-193-21	52959019321	21 in 1 CONTAINER	Historical
52959-193-28	52959019328	28 in 1 CONTAINER	Historical
52959-193-30	52959019330	30 in 1 BOTTLE	Historical
52959-193-40	52959019340	40 in 1 CONTAINER	Historical
52959-193-45	52959019345	45 in 1 CONTAINER	Historical
52959-193-60	52959019360	60 in 1 CONTAINER	Historical
52959-193-90	52959019390	90 in 1 CONTAINER	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NAPROXEN - H.J. Harkins Company., Inc. \| H.J Harkins Company Inc.	H.J. Harkins Company., Inc. \| H.J Harkins Company Inc.	2023-01-26	HUMAN PRESCRIPTION DRUG LABEL	2
Theraproxen-500	Physician Therapeutics LLC \| Glenmark Generics Limited \| H.J. Harkins Company, Inc. \| Targeted Medical Pharma Inc.	2011-08-01	HUMAN PRESCRIPTION DRUG LABEL	8