Naproxen

Product NDC: 68134-201
Requested package NDC: 68134-201-16
11-digit product format: 681340201
Labeler code: 68134
Product ID: 68134-201_038a4d16-fbfb-4295-8da7-3bd71a73df3b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naproxen
Dosage form: SUSPENSION
Route: ORAL
Labeler: Palmetto Pharmaceuticals
Application: ANDA074190
Marketing category: ANDA
Marketing start: 2013-06-25
Marketing end: 2022-08-31
Substance: NAPROXEN
Active strength: 125 mg/5mL
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68134-201	68134-201-16	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 1 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074190-001	NAPROXEN	NAPROXEN	25MG/ML	SUSPENSION / ORAL	AB	RS	1994-03-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074190-001	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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A074190-001	NAPROXEN	25MG/ML	SUSPENSION / ORAL	AB	RS	1994-03-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074190-001	NAPROXEN	25MG/ML	SUSPENSION / ORAL	AB	RS	1994-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074190-001	NAPROXEN	25MG/ML	SUSPENSION / ORAL	AB	RS	1994-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074190-001	NAPROXEN	25MG/ML	SUSPENSION / ORAL	AB	RS	1994-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074190-001	NAPROXEN	25MG/ML	SUSPENSION / ORAL	AB	RS	1994-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074190-001	NAPROXEN	25MG/ML	SUSPENSION / ORAL	AB	RS	1994-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074190-001	NAPROXEN	25MG/ML	SUSPENSION / ORAL	AB	RS	1994-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074190-001	NAPROXEN	25MG/ML	SUSPENSION / ORAL	AB	RS	1994-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074190-001	NAPROXEN	25MG/ML	SUSPENSION / ORAL	AB	RS	1994-03-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074190-001	NAPROXEN	25MG/ML	SUSPENSION / ORAL	AB	RS	1994-03-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074190-001	NAPROXEN	25MG/ML	SUSPENSION / ORAL	AB	RS	1994-03-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074190-001	NAPROXEN	25MG/ML	SUSPENSION / ORAL	AB	RS	1994-03-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074190-001	NAPROXEN	25MG/ML	SUSPENSION / ORAL	AB	RS	1994-03-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074190-001	NAPROXEN	25MG/ML	SUSPENSION / ORAL	AB	RS	1994-03-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074190-001	NAPROXEN	25MG/ML	SUSPENSION / ORAL	AB	RS	1994-03-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074190-001	NAPROXEN	25MG/ML	SUSPENSION / ORAL	AB	RS	1994-03-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074190-001	NAPROXEN	25MG/ML	SUSPENSION / ORAL	AB	RS	1994-03-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074190-001	NAPROXEN	25MG/ML	SUSPENSION / ORAL	AB	RS	1994-03-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074190-001	NAPROXEN	25MG/ML	SUSPENSION / ORAL	AB	RS	1994-03-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074190-001	NAPROXEN	25MG/ML	SUSPENSION / ORAL	AB	RS	1994-03-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074190-001	NAPROXEN	25MG/ML	SUSPENSION / ORAL	AB	RS	1994-03-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074190-001	NAPROXEN	25MG/ML	SUSPENSION / ORAL	AB	RS	1994-03-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074190-001	NAPROXEN	25MG/ML	SUSPENSION / ORAL	AB	RS	1994-03-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074190-001	NAPROXEN	25MG/ML	SUSPENSION / ORAL	AB	RS	1994-03-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074190-001	NAPROXEN	25MG/ML	SUSPENSION / ORAL	AB	RS	1994-03-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074190-001	NAPROXEN	25MG/ML	SUSPENSION / ORAL	AB	RS	1994-03-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074190-001	NAPROXEN	25MG/ML	SUSPENSION / ORAL	AB	RS	1994-03-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074190-001	NAPROXEN	25MG/ML	SUSPENSION / ORAL	AB	RS	1994-03-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074190-001	NAPROXEN	25MG/ML	SUSPENSION / ORAL	AB	RS	1994-03-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074190-001	NAPROXEN	25MG/ML	SUSPENSION / ORAL	AB	RS	1994-03-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074190-001	NAPROXEN	25MG/ML	SUSPENSION / ORAL	AB	RS	1994-03-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074190-001	NAPROXEN	25MG/ML	SUSPENSION / ORAL	AB	RS	1994-03-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074190-001	NAPROXEN	25MG/ML	SUSPENSION / ORAL	AB	RS	1994-03-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074190-001	NAPROXEN	25MG/ML	SUSPENSION / ORAL	AB	RS	1994-03-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074190-001	NAPROXEN	25MG/ML	SUSPENSION / ORAL	AB	RS	1994-03-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074190-001	NAPROXEN	25MG/ML	SUSPENSION / ORAL	AB	RS	1994-03-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074190-001	NAPROXEN	25MG/ML	SUSPENSION / ORAL	AB	RS	1994-03-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074190-001	NAPROXEN	25MG/ML	SUSPENSION / ORAL	AB	RS	1994-03-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074190-001	NAPROXEN	25MG/ML	SUSPENSION / ORAL	AB	RS	1994-03-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074190-001	NAPROXEN	25MG/ML	SUSPENSION / ORAL	AB	RS	1994-03-30	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A074190-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074190-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074190-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074190-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074190-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074190-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074190-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074190-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074190-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074190-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074190-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074190-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074190-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074190-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074190-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074190-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074190-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074190-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074190-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074190-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074190-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074190-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074190-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074190-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074190-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074190-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074190-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074190-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074190-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074190-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074190-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074190-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074190-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074190-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074190-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074190-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074190-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074190-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074190-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074190-001	AB	1	`e64feba35796…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68134-201-16	2021-02-04	C162847	48780-1	ba0f9c33-50d8-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use NAPROXEN ORAL SUSPENSION safely and effectively. See full prescribing information for NAPROXEN ORAL SUSPENSION. NAPROXEN oral suspension Initial U.S. Approval: 1976
68134-201-16	2021-01-29	C162847	48780-1	ba0f9c33-50d8-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use NAPROXEN ORAL SUSPENSION safely and effectively. See full prescribing information for NAPROXEN ORAL SUSPENSION. NAPROXEN oral suspension 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
68134-201-16	ML - Milliliter	68134-201	256d50ac-32f7-4b88-b043-f7c53d418370	1	2016-04-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NAPROXEN	ACTIVE INGREDIENT	57Y76R9ATQ	NAPROXEN SUSPENSION [PALMETTO PHARMACEUTICALS]	3
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN SUSPENSION [PALMETTO PHARMACEUTICALS]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	NAPROXEN SUSPENSION [PALMETTO PHARMACEUTICALS]	3
FUMARIC ACID	INACTIVE INGREDIENT	88XHZ13131	NAPROXEN SUSPENSION [PALMETTO PHARMACEUTICALS]	3
MAGNESIUM ALUMINUM SILICATE	INACTIVE INGREDIENT	6M3P64V0NC	NAPROXEN SUSPENSION [PALMETTO PHARMACEUTICALS]	3
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	NAPROXEN SUSPENSION [PALMETTO PHARMACEUTICALS]	3
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	NAPROXEN SUSPENSION [PALMETTO PHARMACEUTICALS]	3
SORBITOL	INACTIVE INGREDIENT	506T60A25R	NAPROXEN SUSPENSION [PALMETTO PHARMACEUTICALS]	3
SUCROSE	INACTIVE INGREDIENT	C151H8M554	NAPROXEN SUSPENSION [PALMETTO PHARMACEUTICALS]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	NAPROXEN SUSPENSION [PALMETTO PHARMACEUTICALS]	3

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen	NAPROXEN	Hikma Pharmaceuticals USA Inc.	a5757b1a-62c9-4421-9794-6fb121ce9b7e	2024-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074190 application number: ANDA074190

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68134-201-16	68134020116	500 mL in 1 BOTTLE, PLASTIC (68134-201-16)	500 ml	2015-11-24	2022-08-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Naproxen	Palmetto Pharmaceuticals \| West-Ward Columbus Inc.	2021-03-03	HUMAN PRESCRIPTION DRUG LABEL	10