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 ID68462-387_010c0657-c907-477f-8bd7-5d455a5f50eb
NDC68462-387
Product TypeHuman Prescription Drug
Proprietary Namesolifenacin succinate
Generic NameSolifenacin Succinate
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2019-05-20
Marketing CategoryANDA / ANDA
Application NumberANDA209239
Labeler NameGlenmark Pharmaceuticals Inc., USA
Substance NameSOLIFENACIN SUCCINATE
Active Ingredient Strength10 mg/1
Pharm ClassesCholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

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 Date2019-05-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68462-387-30 [68462038730]

solifenacin succinate TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA209239
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-20

NDC 68462-387-14 [68462038714]

solifenacin succinate TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA209239
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-20

NDC 68462-387-90 [68462038790]

solifenacin succinate TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA209239
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-20

Drug Details

Active Ingredients

IngredientStrength
SOLIFENACIN SUCCINATE10 mg/1

OpenFDA Data

SPL SET ID:010c0657-c907-477f-8bd7-5d455a5f50eb
Manufacturer
UNII

Pharmacological Class

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

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

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

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