NDC 69238-1309

Solifenacin Succinate

Solifenacin Succinate

Solifenacin Succinate is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Ny Llc. The primary component is Solifenacin Succinate.

• Product ID: 69238-1309_0e2b4664-a906-47d6-b284-ed93f3787e82
• NDC: 69238-1309
• Product Type: Human Prescription Drug
• Proprietary Name: Solifenacin Succinate
• Generic Name: Solifenacin Succinate
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-05-20
• Marketing Category: ANDA / ANDA
• Application Number: ANDA209719
• Labeler Name: Amneal Pharmaceuticals NY LLC
• 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: 2021-12-31

Packaging

NDC 69238-1309-3

30 TABLET, FILM COATED in 1 BOTTLE (69238-1309-3)

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

NDC SPL Data Element Entries

NDC 69238-1309-7 [69238130907]

Solifenacin Succinate TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA209719
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-05-20

NDC 69238-1309-9 [69238130909]

Solifenacin Succinate TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA209719
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-05-20

NDC 69238-1309-1 [69238130901]

Solifenacin Succinate TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA209719
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-05-20

NDC 69238-1309-3 [69238130903]

Solifenacin Succinate TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA209719
• 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: 5fca0c16-45e0-4bf9-b0a5-09917db24e9d
• Manufacturer:
  • Amneal Pharmaceuticals NY LLC
• UNII:
  • KKA5DLD701

Pharmacological Class

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