solifenacin succinate
- Product NDC
- 68462-386
- 11-digit product format
- 684620386
- Labeler code
- 68462
- Product ID
- 68462-386_85807e7f-3f25-4df8-812e-fa6b281d559b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- solifenacin succinate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA209239
- Marketing category
- ANDA
- Marketing start
- 2019-05-20
- Substance
- SOLIFENACIN SUCCINATE
- Active strength
- 5 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
- solifenacin succinate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SOLIFENACIN SUCCINATE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | KKA5DLD701 |
| Rxcui | 477367, 477372 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68462-386-14 | solifenacin succinate | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 6 |
| 68462-386-14 | solifenacin succinate | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 6 |
| 68462-386-30 | solifenacin succinate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 6 |
| 68462-386-90 | solifenacin succinate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-386 | SOLIFENACIN SUCCINATE TABLET, FILM COATED SOLIFENACIN SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA] | 5 | Current NDC, Legacy NDC, 4 package rows | 20240103_010c0657-c907-477f-8bd7-5d455a5f50eb.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 |
|---|
| 68462-386-14 | 68462038614 | 10 BLISTER PACK in 1 CARTON (68462-386-14) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2019-05-20 | 0000-00-00 | No | No | Current |
| 68462-386-30 | 68462038630 | 30 TABLET, FILM COATED in 1 BOTTLE (68462-386-30) | | 2019-05-20 | 0000-00-00 | No | No | Current |
| 68462-386-90 | 68462038690 | 90 TABLET, FILM COATED in 1 BOTTLE (68462-386-90) | | 2019-05-20 | 0000-00-00 | No | No | Current |