NDC 68462-387

solifenacin succinate

Solifenacin Succinate

solifenacin succinate is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Glenmark Pharmaceuticals Inc., Usa. The primary component is Solifenacin Succinate.

• Product ID: 68462-387_010c0657-c907-477f-8bd7-5d455a5f50eb
• NDC: 68462-387
• Product Type: Human Prescription Drug
• Proprietary Name: solifenacin succinate
• Generic Name: Solifenacin Succinate
• Dosage Form: Tablet, Film Coated, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2019-05-20
• Marketing Category: ANDA / ANDA
• Application Number: ANDA209239
• Labeler Name: Glenmark Pharmaceuticals Inc., USA
• Substance Name: SOLIFENACIN SUCCINATE
• Active Ingredient Strength: 10 mg/1
• Pharm Classes: Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 68462-387-14

10 BLISTER PACK in 1 CARTON (68462-387-14) > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

• Marketing Start Date: 2019-05-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68462-387-30 [68462038730]

solifenacin succinate TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA209239
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-05-20

NDC 68462-387-14 [68462038714]

solifenacin succinate TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA209239
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-05-20

NDC 68462-387-90 [68462038790]

solifenacin succinate TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA209239
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-05-20

Drug Details

Active Ingredients

Ingredient	Strength
SOLIFENACIN SUCCINATE	10 mg/1

OpenFDA Data

• SPL SET ID: 010c0657-c907-477f-8bd7-5d455a5f50eb
• Manufacturer:
  • Glenmark Pharmaceuticals Inc., USA
• UNII:
  • KKA5DLD701

Pharmacological Class

• Cholinergic Muscarinic Antagonist [EPC]
• Cholinergic Muscarinic Antagonists [MoA]

NDC Crossover Matching brand name "solifenacin succinate" or generic name "Solifenacin Succinate"

NDC	Brand Name	Generic Name
0093-5263	Solifenacin Succinate	Solifenacin Succinate
0093-5264	Solifenacin Succinate	Solifenacin Succinate
0591-3795	Solifenacin succinate	solifenacin succinate
0591-3796	Solifenacin succinate	solifenacin succinate
27241-037	solifenacin succinate	solifenacin succinate
27241-038	solifenacin succinate	solifenacin succinate
29300-328	Solifenacin Succinate	Solifenacin Succinate
29300-329	Solifenacin Succinate	Solifenacin Succinate
31722-027	solifenacin succinate	solifenacin succinate
31722-028	solifenacin succinate	solifenacin succinate
35561-285	Solifenacin Succinate	solifenacin succiate
35561-286	Solifenacin Succinate	solifenacin succinate
42291-739	Solifenacin Succinate	solifenacin succiate
42291-740	Solifenacin Succinate	solifenacin succinate
69539-051	Solifenacin Succinate	Solifenacin Succinate
69539-050	Solifenacin Succinate	Solifenacin Succinate
72205-020	Solifenacin Succinate	Solifenacin Succinate
72606-010	solifenacin succinate	solifenacin succinate
72606-009	solifenacin succinate	solifenacin succinate
72205-021	Solifenacin Succinate	Solifenacin Succinate
46708-193	Solifenacin Succinate	Solifenacin Succinate
46708-192	Solifenacin Succinate	Solifenacin Succinate
50228-427	SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE
50228-428	SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE
51407-227	Solifenacin Succinate	Solifenacin Succinate
51407-228	Solifenacin Succinate	Solifenacin Succinate
51991-893	Solifenacin Succinate	Solifenacin Succinate
51991-894	Solifenacin Succinate	Solifenacin Succinate
60505-4703	Solifenacin Succinate	Solifenacin Succinate
60505-4702	Solifenacin Succinate	Solifenacin Succinate
62332-192	Solifenacin Succinate	Solifenacin Succinate
62332-193	Solifenacin Succinate	Solifenacin Succinate
67877-527	Solifenacin Succinate	Solifenacin Succinate
67877-528	Solifenacin Succinate	Solifenacin Succinate
68462-387	solifenacin succinate	solifenacin succinate
68462-386	solifenacin succinate	solifenacin succinate
69238-1309	Solifenacin Succinate	Solifenacin Succinate
69238-1308	Solifenacin Succinate	Solifenacin Succinate
51407-254	SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE
51407-255	SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE
60687-499	Solifenacin Succinate	Solifenacin Succinate
69367-239	Solifenacin Succinate	Solifenacin Succinate
69367-240	Solifenacin Succinate	Solifenacin Succinate