Naproxen

Product NDC: 12634-498
11-digit product format: 126340498
Labeler code: 12634
Product ID: 12634-498_35b8ec82-7260-5925-e054-00144ff8d46c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naproxen
Dosage form: TABLET
Route: ORAL
Labeler: Apotheca Inc.
Application: ANDA075927
Marketing category: ANDA
Marketing start: 2010-02-18
Marketing end: 0000-00-00
Substance: NAPROXEN
Active strength: 250 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 · 37 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	12634-498		I	Inactivated by FDA	2026-08-10
excluded package	package	12634-498	12634-498-00	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-498	12634-498-01	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-498	12634-498-09	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-498	12634-498-40	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-498	12634-498-42	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-498	12634-498-45	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-498	12634-498-50	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-498	12634-498-52	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-498	12634-498-54	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-498	12634-498-57	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-498	12634-498-59	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-498	12634-498-60	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-498	12634-498-61	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-498	12634-498-63	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-498	12634-498-66	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-498	12634-498-67	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-498	12634-498-69	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-498	12634-498-71	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-498	12634-498-74	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-498	12634-498-78	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-498	12634-498-79	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-498	12634-498-80	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-498	12634-498-81	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-498	12634-498-82	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-498	12634-498-84	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-498	12634-498-85	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-498	12634-498-90	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-498	12634-498-91	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-498	12634-498-92	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-498	12634-498-93	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-498	12634-498-94	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-498	12634-498-95	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-498	12634-498-96	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-498	12634-498-97	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-498	12634-498-98	I	Inactivated by FDA	2026-08-10
excluded package	package	12634-498	12634-498-99	I	Inactivated by FDA	2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 13 · 777 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	12634-498-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-498-96	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-498-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-498-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-498-99	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-498-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-498-81	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-498-92	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-498-97	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-498-82	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-498-91	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-498-69	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-498-95	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-498-66	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-498-78	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-498-59	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-498-67	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-498-63	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-498-79	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-498-94	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-498-98	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-498-54	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-498-80	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-498-84	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-498-71	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-498-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-498-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-498-52	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-498-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-498-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-498-42	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-498-57	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-498-93	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-498-85	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-498-74	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-498-61	`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	12634-498-45	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-498-96	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-498-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-498-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-498-99	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-498-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-498-81	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-498-92	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-498-97	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-498-82	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-498-91	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-498-69	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-498-95	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-498-66	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-498-78	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-498-59	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-498-67	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-498-63	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-498-79	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-498-94	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-498-98	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-498-54	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A075927-001	NAPROXEN	NAPROXEN	250MG	TABLET / ORAL	AB	2001-12-18
A075927-002	NAPROXEN	NAPROXEN	375MG	TABLET / ORAL	AB	2001-12-18
A075927-003	NAPROXEN	NAPROXEN	500MG	TABLET / ORAL	AB	2001-12-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075927-001	AB
A075927-002	AB
A075927-003	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075927-001	NAPROXEN	250MG	TABLET / ORAL	AB	2001-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075927-002	NAPROXEN	375MG	TABLET / ORAL	AB	2001-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075927-003	NAPROXEN	500MG	TABLET / ORAL	AB	2001-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075927-001	NAPROXEN	250MG	TABLET / ORAL	AB	2001-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075927-002	NAPROXEN	375MG	TABLET / ORAL	AB	2001-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075927-003	NAPROXEN	500MG	TABLET / ORAL	AB	2001-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075927-001	NAPROXEN	250MG	TABLET / ORAL	AB	2001-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075927-002	NAPROXEN	375MG	TABLET / ORAL	AB	2001-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075927-003	NAPROXEN	500MG	TABLET / ORAL	AB	2001-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075927-001	NAPROXEN	250MG	TABLET / ORAL	AB	2001-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075927-002	NAPROXEN	375MG	TABLET / ORAL	AB	2001-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075927-003	NAPROXEN	500MG	TABLET / ORAL	AB	2001-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075927-001	NAPROXEN	250MG	TABLET / ORAL	AB	2001-12-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075927-002	NAPROXEN	375MG	TABLET / ORAL	AB	2001-12-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075927-003	NAPROXEN	500MG	TABLET / ORAL	AB	2001-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075927-001	NAPROXEN	250MG	TABLET / ORAL	AB	2001-12-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075927-002	NAPROXEN	375MG	TABLET / ORAL	AB	2001-12-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075927-003	NAPROXEN	500MG	TABLET / ORAL	AB	2001-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075927-001	NAPROXEN	250MG	TABLET / ORAL	AB	2001-12-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075927-002	NAPROXEN	375MG	TABLET / ORAL	AB	2001-12-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075927-003	NAPROXEN	500MG	TABLET / ORAL	AB	2001-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075927-001	NAPROXEN	250MG	TABLET / ORAL	AB	2001-12-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075927-002	NAPROXEN	375MG	TABLET / ORAL	AB	2001-12-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075927-003	NAPROXEN	500MG	TABLET / ORAL	AB	2001-12-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075927-001	NAPROXEN	250MG	TABLET / ORAL	AB	2001-12-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075927-002	NAPROXEN	375MG	TABLET / ORAL	AB	2001-12-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075927-003	NAPROXEN	500MG	TABLET / ORAL	AB	2001-12-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075927-001	NAPROXEN	250MG	TABLET / ORAL	AB	2001-12-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075927-002	NAPROXEN	375MG	TABLET / ORAL	AB	2001-12-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075927-003	NAPROXEN	500MG	TABLET / ORAL	AB	2001-12-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075927-001	NAPROXEN	250MG	TABLET / ORAL	AB	2001-12-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075927-002	NAPROXEN	375MG	TABLET / ORAL	AB	2001-12-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075927-003	NAPROXEN	500MG	TABLET / ORAL	AB	2001-12-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075927-001	NAPROXEN	250MG	TABLET / ORAL	AB	2001-12-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075927-002	NAPROXEN	375MG	TABLET / ORAL	AB	2001-12-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075927-003	NAPROXEN	500MG	TABLET / ORAL	AB	2001-12-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075927-001	NAPROXEN	250MG	TABLET / ORAL	AB	2001-12-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075927-002	NAPROXEN	375MG	TABLET / ORAL	AB	2001-12-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075927-003	NAPROXEN	500MG	TABLET / ORAL	AB	2001-12-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075927-001	NAPROXEN	250MG	TABLET / ORAL	AB	2001-12-18	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075927-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075927-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075927-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075927-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075927-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075927-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075927-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075927-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075927-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075927-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075927-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075927-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075927-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075927-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075927-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075927-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075927-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075927-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075927-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075927-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075927-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075927-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075927-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075927-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075927-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075927-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075927-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075927-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075927-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075927-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075927-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075927-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075927-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075927-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075927-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075927-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075927-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075927-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075927-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075927-001	AB	1	`8072bd15b7f6…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fef6ad89-235f-4274-ba49-a8e53642473e	Product name	2	20250225
87fed3e6-8fba-48ef-96b0-3a7fb54b96ff	Product name	3	20230306
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8	Product name	1	20200623
e76dbbc1-775d-722c-08ff-ed45e8a80def	Product name	3	20181002
6f4f4521-fd56-1ae6-888b-3b021bd75c7c	Product name	1	20140508
ce67e27d-1d21-5465-4409-b0662dd99d4d	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
12634-498-00	Naproxen Tablets, USP
12634-498-01	Naproxen Tablets, USP
12634-498-09	Naproxen Tablets, USP
12634-498-40	Naproxen Tablets, USP
12634-498-42	Naproxen Tablets, USP
12634-498-45	Naproxen Tablets, USP
12634-498-50	Naproxen Tablets, USP
12634-498-52	Naproxen Tablets, USP
12634-498-54	Naproxen Tablets, USP
12634-498-57	Naproxen Tablets, USP
12634-498-59	Naproxen Tablets, USP
12634-498-60	Naproxen Tablets, USP
12634-498-61	Naproxen Tablets, USP
12634-498-63	Naproxen Tablets, USP
12634-498-66	Naproxen Tablets, USP
12634-498-67	Naproxen Tablets, USP
12634-498-69	Naproxen Tablets, USP
12634-498-71	Naproxen Tablets, USP
12634-498-74	Naproxen Tablets, USP
12634-498-78	Naproxen Tablets, USP
12634-498-79	Naproxen Tablets, USP
12634-498-80	Naproxen Tablets, USP
12634-498-81	Naproxen Tablets, USP
12634-498-82	Naproxen Tablets, USP
12634-498-84	Naproxen Tablets, USP
12634-498-85	Naproxen Tablets, USP
12634-498-90	Naproxen Tablets, USP
12634-498-91	Naproxen Tablets, USP
12634-498-92	Naproxen Tablets, USP
12634-498-93	Naproxen Tablets, USP
12634-498-94	Naproxen Tablets, USP
12634-498-95	Naproxen Tablets, USP
12634-498-96	Naproxen Tablets, USP
12634-498-97	Naproxen Tablets, USP
12634-498-98	Naproxen Tablets, USP
12634-498-99	Naproxen Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
12634-498-00	Naproxen	10 in 1 BOTTLE	TABLET	10	2
12634-498-01	Naproxen	100 in 1 BOTTLE	TABLET	100	2
12634-498-09	Naproxen	35 in 1 BOTTLE	TABLET	35	2
12634-498-40	Naproxen	40 in 1 BOTTLE	TABLET	40	2
12634-498-42	Naproxen	42 in 1 BOTTLE	TABLET	42	2
12634-498-45	Naproxen	45 in 1 BOTTLE	TABLET	45	2
12634-498-50	Naproxen	50 in 1 BOTTLE	TABLET	50	2
12634-498-52	Naproxen	12 in 1 BLISTER PACK	TABLET	12	2
12634-498-54	Naproxen	14 in 1 BLISTER PACK	TABLET	14	2
12634-498-57	Naproxen	20 in 1 BLISTER PACK	TABLET	20	2
12634-498-59	Naproxen	30 in 1 BLISTER PACK	TABLET	30	2
12634-498-60	Naproxen	60 in 1 BOTTLE	TABLET	60	2
12634-498-61	Naproxen	10 in 1 BLISTER PACK	TABLET	10	2
12634-498-63	Naproxen	3 in 1 BLISTER PACK	TABLET	3	2
12634-498-66	Naproxen	6 in 1 BLISTER PACK	TABLET	6	2
12634-498-67	Naproxen	7 in 1 BLISTER PACK	TABLET	7	2
12634-498-69	Naproxen	9 in 1 BLISTER PACK	TABLET	9	2
12634-498-71	Naproxen	30 in 1 BOTTLE	TABLET	30	2
12634-498-74	Naproxen	24 in 1 BOTTLE	TABLET	24	2
12634-498-78	Naproxen	28 in 1 BOTTLE	TABLET	28	2
12634-498-79	Naproxen	25 in 1 BOTTLE	TABLET	25	2
12634-498-80	Naproxen	20 in 1 BOTTLE	TABLET	20	2
12634-498-81	Naproxen	21 in 1 BOTTLE	TABLET	21	2
12634-498-82	Naproxen	12 in 1 BOTTLE	TABLET	12	2
12634-498-84	Naproxen	14 in 1 BOTTLE	TABLET	14	2
12634-498-85	Naproxen	15 in 1 BOTTLE	TABLET	15	2
12634-498-90	Naproxen	90 in 1 BOTTLE	TABLET	90	2
12634-498-91	Naproxen	1 in 1 BLISTER PACK	TABLET	1	2
12634-498-92	Naproxen	2 in 1 BOTTLE	TABLET	2	2
12634-498-93	Naproxen	3 in 1 BOTTLE	TABLET	3	2
12634-498-94	Naproxen	4 in 1 BOTTLE	TABLET	4	2
12634-498-95	Naproxen	5 in 1 BOTTLE	TABLET	5	2
12634-498-96	Naproxen	6 in 1 BOTTLE	TABLET	6	2
12634-498-97	Naproxen	7 in 1 BOTTLE	TABLET	7	2
12634-498-98	Naproxen	8 in 1 BOTTLE	TABLET	8	2
12634-498-99	Naproxen	9 in 1 BOTTLE	TABLET	9	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
12634-498-71	EA - Each	12634-498	4b6a1d30-349b-454b-9d97-540cf8059ae5	1	2016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12634-498	NAPROXEN TABLET [APOTHECA INC.]	2	Legacy NDC, 36 package rows	20160620_35b8ec82-725f-5925-e054-00144ff8d46c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 18 matching rows.

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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
57Y76R9ATQ	NAPROXEN	22204-53-1	NAPROXEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198013	naproxen 250 MG Oral Tablet	PSN	35b8ec82-725f-5925-e054-00144ff8d46c	2
198013	naproxen 250 MG Oral Tablet	SCD	35b8ec82-725f-5925-e054-00144ff8d46c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
12634-498-00	12634049800	10 in 1 BOTTLE	Historical
12634-498-01	12634049801	100 in 1 BOTTLE	Historical
12634-498-09	12634049809	35 in 1 BOTTLE	Historical
12634-498-40	12634049840	40 in 1 BOTTLE	Historical
12634-498-42	12634049842	42 in 1 BOTTLE	Historical
12634-498-45	12634049845	45 in 1 BOTTLE	Historical
12634-498-50	12634049850	50 in 1 BOTTLE	Historical
12634-498-52	12634049852	12 in 1 BLISTER PACK	Historical
12634-498-54	12634049854	14 in 1 BLISTER PACK	Historical
12634-498-57	12634049857	20 in 1 BLISTER PACK	Historical
12634-498-59	12634049859	30 in 1 BLISTER PACK	Historical
12634-498-60	12634049860	60 in 1 BOTTLE	Historical
12634-498-61	12634049861	10 in 1 BLISTER PACK	Historical
12634-498-63	12634049863	3 in 1 BLISTER PACK	Historical
12634-498-66	12634049866	6 in 1 BLISTER PACK	Historical
12634-498-67	12634049867	7 in 1 BLISTER PACK	Historical
12634-498-69	12634049869	9 in 1 BLISTER PACK	Historical
12634-498-71	12634049871	30 in 1 BOTTLE	Historical
12634-498-74	12634049874	24 in 1 BOTTLE	Historical
12634-498-78	12634049878	28 in 1 BOTTLE	Historical
12634-498-79	12634049879	25 in 1 BOTTLE	Historical
12634-498-80	12634049880	20 in 1 BOTTLE	Historical
12634-498-81	12634049881	21 in 1 BOTTLE	Historical
12634-498-82	12634049882	12 in 1 BOTTLE	Historical
12634-498-84	12634049884	14 in 1 BOTTLE	Historical
12634-498-85	12634049885	15 in 1 BOTTLE	Historical
12634-498-90	12634049890	90 in 1 BOTTLE	Historical
12634-498-91	12634049891	1 in 1 BLISTER PACK	Historical
12634-498-92	12634049892	2 in 1 BOTTLE	Historical
12634-498-93	12634049893	3 in 1 BOTTLE	Historical
12634-498-94	12634049894	4 in 1 BOTTLE	Historical
12634-498-95	12634049895	5 in 1 BOTTLE	Historical
12634-498-96	12634049896	6 in 1 BOTTLE	Historical
12634-498-97	12634049897	7 in 1 BOTTLE	Historical
12634-498-98	12634049898	8 in 1 BOTTLE	Historical
12634-498-99	12634049899	9 in 1 BOTTLE	Historical