Tolmetin Sodium

Product NDC
72336-118
11-digit product format
723360118
Labeler code
72336
Product ID
72336-118_513fcbbb-b0a8-55e9-e063-6394a90a5e05
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tolmetin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Lifsa Drugs 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 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A073588-001TOLMETIN SODIUMTOLMETIN SODIUMEQ 200MG BASETABLET / ORAL1992-07-31

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A073588-001TOLMETIN SODIUMEQ 200MG BASETABLET / ORAL1992-07-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A073588-001TOLMETIN SODIUMEQ 200MG BASETABLET / ORAL1992-07-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073588-001TOLMETIN SODIUMEQ 200MG BASETABLET / ORAL1992-07-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A073588-001TOLMETIN SODIUMEQ 200MG BASETABLET / ORAL1992-07-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073588-001TOLMETIN SODIUMEQ 200MG BASETABLET / ORAL1992-07-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073588-001TOLMETIN SODIUMEQ 200MG BASETABLET / ORAL1992-07-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073588-001TOLMETIN SODIUMEQ 200MG BASETABLET / ORAL1992-07-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073588-001TOLMETIN SODIUMEQ 200MG BASETABLET / ORAL1992-07-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073588-001TOLMETIN SODIUMEQ 200MG BASETABLET / ORAL1992-07-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073588-001TOLMETIN SODIUMEQ 200MG BASETABLET / ORAL1992-07-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A073588-001TOLMETIN SODIUMEQ 200MG BASETABLET / ORAL1992-07-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073588-001TOLMETIN SODIUMEQ 200MG BASETABLET / ORAL1992-07-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073588-001TOLMETIN SODIUMEQ 200MG BASETABLET / ORAL1992-07-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073588-001TOLMETIN SODIUMEQ 200MG BASETABLET / ORAL1992-07-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A073588-001TOLMETIN SODIUMEQ 200MG BASETABLET / ORAL1992-07-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A073588-001TOLMETIN SODIUMEQ 200MG BASETABLET / ORAL1992-07-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A073588-001TOLMETIN SODIUMEQ 200MG BASETABLET / ORAL1992-07-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A073588-001TOLMETIN SODIUMEQ 200MG BASETABLET / ORAL1992-07-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A073588-001TOLMETIN SODIUMEQ 200MG BASETABLET / ORAL1992-07-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A073588-001TOLMETIN SODIUMEQ 200MG BASETABLET / ORAL1992-07-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A073588-001TOLMETIN SODIUMEQ 200MG BASETABLET / ORAL1992-07-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A073588-001TOLMETIN SODIUMEQ 200MG BASETABLET / ORAL1992-07-3187673890dc5c…
2021-03-12 10:30 UTC2021-03A073588-001TOLMETIN SODIUMEQ 200MG BASETABLET / ORAL1992-07-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A073588-001TOLMETIN SODIUMEQ 200MG BASETABLET / ORAL1992-07-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A073588-001TOLMETIN SODIUMEQ 200MG BASETABLET / ORAL1992-07-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A073588-001TOLMETIN SODIUMEQ 200MG BASETABLET / ORAL1992-07-313f01610625f2…
2019-09-15 20:21 UTC2019-09A073588-001TOLMETIN SODIUMEQ 200MG BASETABLET / ORAL1992-07-31b00525d2431f…
2019-07-19 19:46 UTC2019-07A073588-001TOLMETIN SODIUMEQ 200MG BASETABLET / ORAL1992-07-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A073588-001TOLMETIN SODIUMEQ 200MG BASETABLET / ORAL1992-07-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A073588-001TOLMETIN SODIUMEQ 200MG BASETABLET / ORAL1992-07-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A073588-001TOLMETIN SODIUMEQ 200MG BASETABLET / ORAL1992-07-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A073588-001TOLMETIN SODIUMEQ 200MG BASETABLET / ORAL1992-07-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A073588-001TOLMETIN SODIUMEQ 200MG BASETABLET / ORAL1992-07-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A073588-001TOLMETIN SODIUMEQ 200MG BASETABLET / ORAL1992-07-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A073588-001TOLMETIN SODIUMEQ 200MG BASETABLET / ORAL1992-07-313f0d92c62455…
2023-05-13 08:27 UTC2023-05A073588-001TOLMETIN SODIUMEQ 200MG BASETABLET / ORAL1992-07-31053a50430f4f…
2023-01-26 05:58 UTC2023-01A073588-001TOLMETIN SODIUMEQ 200MG BASETABLET / ORAL1992-07-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A073588-001TOLMETIN SODIUMEQ 200MG BASETABLET / ORAL1992-07-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A073588-001TOLMETIN SODIUMEQ 200MG BASETABLET / ORAL1992-07-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A073588-001TOLMETIN SODIUMEQ 200MG BASETABLET / ORAL1992-07-31e64feba35796…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLMETIN SODIUM200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
02N1TZF99FInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7b26321c-4797-4664-a162-e29de4b8dd93Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ad3a5dc6-863f-442d-2886-f8a057d6cb13Product name120140508
e10d0ded-5358-1a18-d5a9-92245cfbbbf9Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72336-118-30Tolmetin Sodium30 in 1 BOTTLETABLET301

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tolmetin SodiumTOLMETIN SODIUMChartwell RX, LLC66fa5e73-477c-4bbc-b7d3-f4a69aad44602026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073588
application number: ANDA073588
Tolmetin SodiumTOLMETIN SODIUMLifsa Drugs LLC7b26321c-4797-4664-a162-e29de4b8dd932026-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073588
application number: ANDA073588
ndc (product): 72336-118

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198295tolmetin sodium 200 MG Oral TabletPSN7b26321c-4797-4664-a162-e29de4b8dd931
198295tolmetin 200 MG Oral TabletSCD7b26321c-4797-4664-a162-e29de4b8dd931

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72336-118-307233601183030 TABLET in 1 BOTTLE (72336-118-30) 30 tablet2026-05-05NoNoCurrent