Tolmetin Sodium

Product NDC: 62135-062
11-digit product format: 621350062
Labeler code: 62135
Product ID: 62135-062_570a80ab-c357-0c6d-e063-6294a90a5d3a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tolmetin Sodium
Dosage form: TABLET
Route: ORAL
Labeler: Chartwell RX, LLC
Application: ANDA073588
Marketing category: ANDA
Marketing start: 1992-07-31
Substance: TOLMETIN SODIUM
Active strength: 200 mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A073588-001	TOLMETIN SODIUM	TOLMETIN SODIUM	EQ 200MG BASE	TABLET / ORAL			1992-07-31

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A073588-001	TOLMETIN SODIUM	EQ 200MG BASE	TABLET / ORAL	1992-07-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A073588-001	TOLMETIN SODIUM	EQ 200MG BASE	TABLET / ORAL	1992-07-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A073588-001	TOLMETIN SODIUM	EQ 200MG BASE	TABLET / ORAL	1992-07-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073588-001	TOLMETIN SODIUM	EQ 200MG BASE	TABLET / ORAL	1992-07-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073588-001	TOLMETIN SODIUM	EQ 200MG BASE	TABLET / ORAL	1992-07-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073588-001	TOLMETIN SODIUM	EQ 200MG BASE	TABLET / ORAL	1992-07-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073588-001	TOLMETIN SODIUM	EQ 200MG BASE	TABLET / ORAL	1992-07-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073588-001	TOLMETIN SODIUM	EQ 200MG BASE	TABLET / ORAL	1992-07-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073588-001	TOLMETIN SODIUM	EQ 200MG BASE	TABLET / ORAL	1992-07-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073588-001	TOLMETIN SODIUM	EQ 200MG BASE	TABLET / ORAL	1992-07-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073588-001	TOLMETIN SODIUM	EQ 200MG BASE	TABLET / ORAL	1992-07-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073588-001	TOLMETIN SODIUM	EQ 200MG BASE	TABLET / ORAL	1992-07-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073588-001	TOLMETIN SODIUM	EQ 200MG BASE	TABLET / ORAL	1992-07-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073588-001	TOLMETIN SODIUM	EQ 200MG BASE	TABLET / ORAL	1992-07-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073588-001	TOLMETIN SODIUM	EQ 200MG BASE	TABLET / ORAL	1992-07-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073588-001	TOLMETIN SODIUM	EQ 200MG BASE	TABLET / ORAL	1992-07-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073588-001	TOLMETIN SODIUM	EQ 200MG BASE	TABLET / ORAL	1992-07-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073588-001	TOLMETIN SODIUM	EQ 200MG BASE	TABLET / ORAL	1992-07-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073588-001	TOLMETIN SODIUM	EQ 200MG BASE	TABLET / ORAL	1992-07-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073588-001	TOLMETIN SODIUM	EQ 200MG BASE	TABLET / ORAL	1992-07-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073588-001	TOLMETIN SODIUM	EQ 200MG BASE	TABLET / ORAL	1992-07-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073588-001	TOLMETIN SODIUM	EQ 200MG BASE	TABLET / ORAL	1992-07-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073588-001	TOLMETIN SODIUM	EQ 200MG BASE	TABLET / ORAL	1992-07-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073588-001	TOLMETIN SODIUM	EQ 200MG BASE	TABLET / ORAL	1992-07-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073588-001	TOLMETIN SODIUM	EQ 200MG BASE	TABLET / ORAL	1992-07-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073588-001	TOLMETIN SODIUM	EQ 200MG BASE	TABLET / ORAL	1992-07-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073588-001	TOLMETIN SODIUM	EQ 200MG BASE	TABLET / ORAL	1992-07-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073588-001	TOLMETIN SODIUM	EQ 200MG BASE	TABLET / ORAL	1992-07-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073588-001	TOLMETIN SODIUM	EQ 200MG BASE	TABLET / ORAL	1992-07-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073588-001	TOLMETIN SODIUM	EQ 200MG BASE	TABLET / ORAL	1992-07-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073588-001	TOLMETIN SODIUM	EQ 200MG BASE	TABLET / ORAL	1992-07-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073588-001	TOLMETIN SODIUM	EQ 200MG BASE	TABLET / ORAL	1992-07-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073588-001	TOLMETIN SODIUM	EQ 200MG BASE	TABLET / ORAL	1992-07-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073588-001	TOLMETIN SODIUM	EQ 200MG BASE	TABLET / ORAL	1992-07-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073588-001	TOLMETIN SODIUM	EQ 200MG BASE	TABLET / ORAL	1992-07-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073588-001	TOLMETIN SODIUM	EQ 200MG BASE	TABLET / ORAL	1992-07-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073588-001	TOLMETIN SODIUM	EQ 200MG BASE	TABLET / ORAL	1992-07-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073588-001	TOLMETIN SODIUM	EQ 200MG BASE	TABLET / ORAL	1992-07-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073588-001	TOLMETIN SODIUM	EQ 200MG BASE	TABLET / ORAL	1992-07-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073588-001	TOLMETIN SODIUM	EQ 200MG BASE	TABLET / ORAL	1992-07-31	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Tolmetin Sodium
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TOLMETIN SODIUM	200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
02N1TZF99F	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198295	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
66fa5e73-477c-4bbc-b7d3-f4a69aad4460	Available on FDA.report

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	Chartwell RX, LLC	66fa5e73-477c-4bbc-b7d3-f4a69aad4460	2026-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073588 application number: ANDA073588 ndc (product): 62135-062
Tolmetin Sodium	TOLMETIN SODIUM	Lifsa Drugs LLC	7b26321c-4797-4664-a162-e29de4b8dd93	2026-05-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073588 application number: ANDA073588

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	Sample	Exclude flag	Status
62135-062-30	62135006230	30 TABLET in 1 BOTTLE (62135-062-30)	30 tablet	2026-07-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TOLMETIN SODIUM- tolmetin sodium tablet - Chartwell Rx only	Chartwell RX, LLC	2026-07-20	HUMAN PRESCRIPTION DRUG LABEL	1