Tolmetin Sodium

Product NDC
0378-0313
11-digit product format
003780313
Labeler code
0378
Product ID
0378-0313_b172e608-09ec-447f-bee4-d7c74e46420d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tolmetin sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA074473
Marketing category
ANDA
Marketing start
1994-08-30
Marketing end
0000-00-00
Substance
TOLMETIN SODIUM
Active strength
600 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

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-0313-01EA - Each0378-031324ff9d1e-a2da-49ba-b8f3-0dfc06139aa812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOLMETIN SODIUMACTIVE INGREDIENT02N1TZF99FTOLMETIN SODIUM TABLET, FILM COATED [STAT RX USA LLC]1
TOLMETINACTIVE MOIETYD8K2JPN18BTOLMETIN SODIUM TABLET, FILM COATED [STAT RX USA LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOLMETIN SODIUM TABLET, FILM COATED [STAT RX USA LLC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKTOLMETIN SODIUM TABLET, FILM COATED [STAT RX USA LLC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTOLMETIN SODIUM TABLET, FILM COATED [STAT RX USA LLC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TOLMETIN SODIUM TABLET, FILM COATED [STAT RX USA LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTOLMETIN SODIUM TABLET, FILM COATED [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOLMETIN SODIUM TABLET, FILM COATED [STAT RX USA LLC]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IETOLMETIN SODIUM TABLET, FILM COATED [STAT RX USA LLC]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ATOLMETIN SODIUM TABLET, FILM COATED [STAT RX USA LLC]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ETOLMETIN SODIUM TABLET, FILM COATED [STAT RX USA LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTOLMETIN SODIUM TABLET, FILM COATED [STAT RX USA LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTOLMETIN SODIUM TABLET, FILM COATED [STAT RX USA LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOLMETIN SODIUM TABLET, FILM COATED [STAT RX USA LLC]1
TRIACETININACTIVE INGREDIENTXHX3C3X673TOLMETIN SODIUM TABLET, FILM COATED [STAT RX USA LLC]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198297tolmetin sodium 600 MG Oral TabletPSN4b4b0091-bcf9-499e-a23e-efcee252f2f61
198297tolmetin 600 MG Oral TabletSCD4b4b0091-bcf9-499e-a23e-efcee252f2f61
198297tolmetin 600 MG (as tolmetin sodium 738 MG) Oral TabletSY4b4b0091-bcf9-499e-a23e-efcee252f2f61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-0313-0100378031301100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0313-01) 1994-08-300000-00-00NoNoCurrent