Tolmetin Sodium

Product NDC: 0378-5200
11-digit product format: 003785200
Labeler code: 0378
Product ID: 0378-5200_6dfeb00a-0dc0-446e-9632-a0d2496c53bd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tolmetin Sodium
Dosage form: CAPSULE
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA073393
Marketing category: ANDA
Marketing start: 1993-05-27
Marketing end: 0000-00-00
Substance: TOLMETIN SODIUM
Active strength: 400 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: 2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0378-5200		D	Discontinued by firm		2026-08-17
excluded package	package	0378-5200	0378-5200-01	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 · 24 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	0378-5200-01	`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	0378-5200-01	`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	0378-5200-01	`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	0378-5200-01	`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	0378-5200-01	`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	0378-5200-01	`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	0378-5200-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0378-5200-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0378-5200-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0378-5200-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0378-5200-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0378-5200-01	`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
A073393-001	TOLMETIN SODIUM	TOLMETIN SODIUM	EQ 400MG BASE	CAPSULE / ORAL		RS	1993-05-27

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	A073393-001	TOLMETIN SODIUM	EQ 400MG BASE	CAPSULE / ORAL		RS	1993-05-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A073393-001	TOLMETIN SODIUM	EQ 400MG BASE	CAPSULE / ORAL		RS	1993-05-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073393-001	TOLMETIN SODIUM	EQ 400MG BASE	CAPSULE / ORAL		RS	1993-05-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073393-001	TOLMETIN SODIUM	EQ 400MG BASE	CAPSULE / ORAL		RS	1993-05-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073393-001	TOLMETIN SODIUM	EQ 400MG BASE	CAPSULE / ORAL		RS	1993-05-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073393-001	TOLMETIN SODIUM	EQ 400MG BASE	CAPSULE / ORAL		RS	1993-05-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073393-001	TOLMETIN SODIUM	EQ 400MG BASE	CAPSULE / ORAL		RS	1993-05-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073393-001	TOLMETIN SODIUM	EQ 400MG BASE	CAPSULE / ORAL		RS	1993-05-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073393-001	TOLMETIN SODIUM	EQ 400MG BASE	CAPSULE / ORAL			1993-05-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073393-001	TOLMETIN SODIUM	EQ 400MG BASE	CAPSULE / ORAL		RS	1993-05-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073393-001	TOLMETIN SODIUM	EQ 400MG BASE	CAPSULE / ORAL			1993-05-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073393-001	TOLMETIN SODIUM	EQ 400MG BASE	CAPSULE / ORAL			1993-05-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073393-001	TOLMETIN SODIUM	EQ 400MG BASE	CAPSULE / ORAL			1993-05-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073393-001	TOLMETIN SODIUM	EQ 400MG BASE	CAPSULE / ORAL			1993-05-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073393-001	TOLMETIN SODIUM	EQ 400MG BASE	CAPSULE / ORAL			1993-05-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073393-001	TOLMETIN SODIUM	EQ 400MG BASE	CAPSULE / ORAL			1993-05-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073393-001	TOLMETIN SODIUM	EQ 400MG BASE	CAPSULE / ORAL			1993-05-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073393-001	TOLMETIN SODIUM	EQ 400MG BASE	CAPSULE / ORAL			1993-05-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073393-001	TOLMETIN SODIUM	EQ 400MG BASE	CAPSULE / ORAL	AB		1993-05-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073393-001	TOLMETIN SODIUM	EQ 400MG BASE	CAPSULE / ORAL			1993-05-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073393-001	TOLMETIN SODIUM	EQ 400MG BASE	CAPSULE / ORAL			1993-05-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073393-001	TOLMETIN SODIUM	EQ 400MG BASE	CAPSULE / ORAL	AB		1993-05-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073393-001	TOLMETIN SODIUM	EQ 400MG BASE	CAPSULE / ORAL	AB		1993-05-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073393-001	TOLMETIN SODIUM	EQ 400MG BASE	CAPSULE / ORAL	AB		1993-05-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073393-001	TOLMETIN SODIUM	EQ 400MG BASE	CAPSULE / ORAL	AB		1993-05-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073393-001	TOLMETIN SODIUM	EQ 400MG BASE	CAPSULE / ORAL	AB		1993-05-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073393-001	TOLMETIN SODIUM	EQ 400MG BASE	CAPSULE / ORAL	AB		1993-05-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073393-001	TOLMETIN SODIUM	EQ 400MG BASE	CAPSULE / ORAL	AB		1993-05-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073393-001	TOLMETIN SODIUM	EQ 400MG BASE	CAPSULE / ORAL			1993-05-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073393-001	TOLMETIN SODIUM	EQ 400MG BASE	CAPSULE / ORAL			1993-05-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073393-001	TOLMETIN SODIUM	EQ 400MG BASE	CAPSULE / ORAL			1993-05-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073393-001	TOLMETIN SODIUM	EQ 400MG BASE	CAPSULE / ORAL			1993-05-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073393-001	TOLMETIN SODIUM	EQ 400MG BASE	CAPSULE / ORAL			1993-05-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073393-001	TOLMETIN SODIUM	EQ 400MG BASE	CAPSULE / ORAL			1993-05-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073393-001	TOLMETIN SODIUM	EQ 400MG BASE	CAPSULE / ORAL			1993-05-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073393-001	TOLMETIN SODIUM	EQ 400MG BASE	CAPSULE / ORAL			1993-05-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073393-001	TOLMETIN SODIUM	EQ 400MG BASE	CAPSULE / ORAL			1993-05-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073393-001	TOLMETIN SODIUM	EQ 400MG BASE	CAPSULE / ORAL			1993-05-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073393-001	TOLMETIN SODIUM	EQ 400MG BASE	CAPSULE / ORAL			1993-05-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A073393-001	TOLMETIN SODIUM	EQ 400MG BASE	CAPSULE / ORAL			1993-05-27	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A073393-001	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073393-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073393-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073393-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073393-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073393-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073393-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073393-001	AB	1	`ea99ee380514…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-5200-01	EA - Each	0378-5200	42ada09f-582a-4481-99dc-e21a91f50d24	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TOLMETIN SODIUM	ACTIVE INGREDIENT	02N1TZF99F	TOLMETIN SODIUM CAPSULE [MYLAN PHARMACEUTICALS INC.]	6
TOLMETIN	ACTIVE MOIETY	D8K2JPN18B	TOLMETIN SODIUM CAPSULE [MYLAN PHARMACEUTICALS INC.]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TOLMETIN SODIUM CAPSULE [MYLAN PHARMACEUTICALS INC.]	6
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	TOLMETIN SODIUM CAPSULE [MYLAN PHARMACEUTICALS INC.]	6
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	TOLMETIN SODIUM CAPSULE [MYLAN PHARMACEUTICALS INC.]	6
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	TOLMETIN SODIUM CAPSULE [MYLAN PHARMACEUTICALS INC.]	6
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	TOLMETIN SODIUM CAPSULE [MYLAN PHARMACEUTICALS INC.]	6
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	TOLMETIN SODIUM CAPSULE [MYLAN PHARMACEUTICALS INC.]	6
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TOLMETIN SODIUM CAPSULE [MYLAN PHARMACEUTICALS INC.]	6
GELATIN	INACTIVE INGREDIENT	2G86QN327L	TOLMETIN SODIUM CAPSULE [MYLAN PHARMACEUTICALS INC.]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TOLMETIN SODIUM CAPSULE [MYLAN PHARMACEUTICALS INC.]	6
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TOLMETIN SODIUM CAPSULE [MYLAN PHARMACEUTICALS INC.]	6
SHELLAC	INACTIVE INGREDIENT	46N107B71O	TOLMETIN SODIUM CAPSULE [MYLAN PHARMACEUTICALS INC.]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TOLMETIN SODIUM CAPSULE [MYLAN PHARMACEUTICALS INC.]	6
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TOLMETIN SODIUM CAPSULE [MYLAN PHARMACEUTICALS INC.]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TOLMETIN SODIUM CAPSULE [MYLAN PHARMACEUTICALS INC.]	6

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TOLMETIN SODIUM	TOLMETIN SODIUM	Galt Pharmaceuticals, LLC	0a97800f-706d-4787-98fe-08dadf9c4d5f	2026-03-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073393 application number: ANDA073393
Tolmetin Sodium	TOLMETIN SODIUM	Atland Pharmaceuticals, LLC	41b7704e-25a1-45e8-93c0-9ac2f0effef9	2025-03-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073393 application number: ANDA073393

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
02N1TZF99F	TOLMETIN SODIUM	64490-92-2	TOLMETIN SODIUM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-5200-01	00378520001	100 CAPSULE in 1 BOTTLE, PLASTIC (0378-5200-01)	100 capsule	1993-05-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tolmetin Sodium - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2021-05-20	HUMAN PRESCRIPTION DRUG LABEL	10