Tolterodine tartrate
- Product NDC
- 33342-098
- 11-digit product format
- 333420098
- Labeler code
- 33342
- Product ID
- 33342-098_fa641ff6-005b-47c5-bade-8709129d7ac9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tolterodine tartrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Macleods Pharmaceuticals Limited
- Application
- ANDA203409
- Marketing category
- ANDA
- Marketing start
- 2020-10-08
- Substance
- TOLTERODINE TARTRATE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tolterodine tartrate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TOLTERODINE TARTRATE | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5T619TQR3R |
| Rxcui | 855178, 855194 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 33342-098-09 | Tolterodine tartrate | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 4 |
| 33342-098-12 | Tolterodine tartrate | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 4 |
| 33342-098-12 | Tolterodine tartrate | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 4 |
| 33342-098-15 | Tolterodine tartrate | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 4 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| TOLTERODINE TARTRATE | ACTIVE INGREDIENT | 5T619TQR3R | TOLTERODINE TARTRATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 1 | |
| TOLTERODINE | ACTIVE MOIETY | WHE7A56U7K | TOLTERODINE TARTRATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TOLTERODINE TARTRATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | TOLTERODINE TARTRATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 1 | |
| DIBASIC CALCIUM PHOSPHATE DIHYDRATE | INACTIVE INGREDIENT | O7TSZ97GEP | TOLTERODINE TARTRATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | TOLTERODINE TARTRATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TOLTERODINE TARTRATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | TOLTERODINE TARTRATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | TOLTERODINE TARTRATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | TOLTERODINE TARTRATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 33342-098 | TOLTERODINE TARTRATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 4 | Current NDC, Legacy NDC, 4 package rows | 20221126_3f2291c3-7e3c-41be-afa6-ef73ce896e30.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 33342-098-09 | 33342009809 | 60 TABLET, FILM COATED in 1 BOTTLE (33342-098-09) | | 2020-10-08 | 0000-00-00 | No | No | Current |
| 33342-098-12 | 33342009812 | 10 BLISTER PACK in 1 CARTON (33342-098-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2020-10-08 | 0000-00-00 | No | No | Current |
| 33342-098-15 | 33342009815 | 500 TABLET, FILM COATED in 1 BOTTLE (33342-098-15) | | 2020-10-08 | 0000-00-00 | No | No | Current |