Tolterodine Tartrate
- Product NDC
- 50090-3475
- 11-digit product format
- 500903475
- Labeler code
- 50090
- Product ID
- 50090-3475_9031ca7e-ead2-404d-a98e-d8dbd2eff0d5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tolterodine Tartrate
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA079141
- Marketing category
- ANDA
- Marketing start
- 2017-03-20
- Substance
- TOLTERODINE TARTRATE
- Active strength
- 4 mg/1
- Pharmacologic classes
- Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tolterodine Tartrate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TOLTERODINE TARTRATE | 4 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5T619TQR3R |
| Rxcui | 855189 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 50090-3475-0 | 2023-02-06 | C162847 | 48780-1 | f386c649-f6b7-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use TOLTERODINE TARTRATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for TOLTERODINE TARTRATE EXTENDED-RELEASE CAPSULES. TOLTERODINE TARTRATE extended-release capsules, for oral administration Initial U.S. Approval: December 2000 |
| 50090-3475-0 | 2023-02-06 | C162847 | 48780-1 | f386c649-f6b7-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use TOLTERODINE TARTRATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for TOLTERODINE TARTRATE EXTENDED-RELEASE CAPSULES. TOLTERODINE TARTRATE extended-release capsules, for oral administration Initial U.S. Approval: December 2000 |
| 50090-3475-1 | 2023-02-06 | C162847 | 48780-1 | f386c649-f6b7-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use TOLTERODINE TARTRATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for TOLTERODINE TARTRATE EXTENDED-RELEASE CAPSULES. TOLTERODINE TARTRATE extended-release capsules, for oral administration Initial U.S. Approval: December 2000 |
| 50090-3475-1 | 2023-02-06 | C162847 | 48780-1 | f386c649-f6b7-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use TOLTERODINE TARTRATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for TOLTERODINE TARTRATE EXTENDED-RELEASE CAPSULES. TOLTERODINE TARTRATE extended-release capsules, for oral administration Initial U.S. Approval: December 2000 |
| 50090-3475-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-f6b7-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use TOLTERODINE TARTRATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for TOLTERODINE TARTRATE EXTENDED-RELEASE CAPSULES. TOLTERODINE TARTRATE extended-release capsules, for oral administration Initial U.S. Approval: December 2000 |
| 50090-3475-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-f6b7-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use TOLTERODINE TARTRATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for TOLTERODINE TARTRATE EXTENDED-RELEASE CAPSULES. TOLTERODINE TARTRATE extended-release capsules, for oral administration Initial U.S. Approval: December 2000 |
| 50090-3475-1 | 2023-01-30 | C162847 | 48780-1 | f386c649-f6b7-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use TOLTERODINE TARTRATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for TOLTERODINE TARTRATE EXTENDED-RELEASE CAPSULES. TOLTERODINE TARTRATE extended-release capsules, for oral administration Initial U.S. Approval: December 2000 |
| 50090-3475-1 | 2023-01-30 | C162847 | 48780-1 | f386c649-f6b7-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use TOLTERODINE TARTRATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for TOLTERODINE TARTRATE EXTENDED-RELEASE CAPSULES. TOLTERODINE TARTRATE extended-release capsules, for oral administration Initial U.S. Approval: December 2000 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-3475-0 | Tolterodine Tartrate | 30 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 30 | | 15 |
| 50090-3475-1 | Tolterodine Tartrate | 90 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 90 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-3475 | TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS] | 13 | Current NDC, Legacy NDC, 2 package rows | 20230806_fd6c8b3d-a52a-4418-aa9c-0297db6c0807.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50090-3475-0 | 50090347500 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-3475-0) | 2019-10-09 | 0000-00-00 | No | No | Current |
| 50090-3475-1 | 50090347501 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-3475-1) | 2018-06-14 | 0000-00-00 | No | No | Current |