Tolmetin Sodium

Product NDC: 16571-826
11-digit product format: 165710826
Labeler code: 16571
Product ID: 16571-826_a6175635-172e-4b9e-8388-b60c2aa117a2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tolmetin Sodium
Dosage form: CAPSULE
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA073393
Marketing category: ANDA
Marketing start: 2023-06-30
Marketing end: 2026-05-31
Substance: TOLMETIN SODIUM
Active strength: 400 mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Current FDA listing: Yes

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	16571-826		D	Discontinued by firm		2026-08-17
excluded package	package	16571-826	16571-826-09	D	Discontinued by firm		2026-08-17

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 Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ad3a5dc6-863f-442d-2886-f8a057d6cb13	Product name	1	20140508
e10d0ded-5358-1a18-d5a9-92245cfbbbf9	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
16571-826-09	Tolmetin Sodium	90 in 1 BOTTLE	CAPSULE	90		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16571-826-09	EA - Each	16571-826	34578a17-4fa7-49b7-89c2-4ede5cdc3336	1	2023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16571-826	TOLMETIN SODIUM CAPSULE [RISING PHARMA HOLDINGS, INC.]	4	Current NDC, 1 package rows	20241211_740a0f37-aa95-4558-b415-be516b8c40a3.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 · 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
16571-826-09	16571082609	90 CAPSULE in 1 BOTTLE (16571-826-09)	90 capsule	2023-06-30	2026-05-31	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tolmetin Sodium Capsules, USP 400 mg Rx only	Rising Pharma Holdings, Inc. \| APPCO PHARMA LLC	2024-12-04	Human Prescription Drug Label	4