NDC 75854-307

Prenate AM

.pyridoxine Hydrochloride, Cyanocobalamin, Calcium Carbonate And Folic Acid

Prenate AM is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Avion Pharmaceuticals, Llc. The primary component is Pyridoxine Hydrochloride; Cyanocobalamin; Calcium Carbonate; Folic Acid.

Product ID75854-307_620b16ea-7269-2c3c-e053-2a91aa0a61cf
NDC75854-307
Product TypeHuman Prescription Drug
Proprietary NamePrenate AM
Generic Name.pyridoxine Hydrochloride, Cyanocobalamin, Calcium Carbonate And Folic Acid
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2013-06-15
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameAvion Pharmaceuticals, LLC
Substance NamePYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; CALCIUM CARBONATE; FOLIC ACID
Active Ingredient Strength75 mg/1; ug/1; mg/1; mg/1
Pharm ClassesVitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 75854-307-30

30 TABLET, COATED in 1 BOTTLE (75854-307-30)
Marketing Start Date2013-06-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 75854-307-30 [75854030730]

Prenate AM TABLET, COATED
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-06-15
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
PYRIDOXINE HYDROCHLORIDE75 mg/1

OpenFDA Data

SPL SET ID:961e9823-88be-44fa-9148-b4704aa3b74e
Manufacturer
UNII

Pharmacological Class

  • Vitamin B6 Analog [EPC]
  • Vitamin B 6 [Chemical/Ingredient]
  • Analogs/Derivatives [Chemical/Ingredient]
  • Vitamin B 12 [CS]
  • Vitamin B12 [EPC]
  • Blood Coagulation Factor [EPC]
  • Increased Coagulation Factor Activity [PE]
  • Calcium [CS]
  • Cations
  • Divalent [CS]

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