NDC 15338-522

PRENATAL PLUS

Vitamin A Acetate, Beta Carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, Ferrous Fumarate, Zinc Oxide, Cupric Oxide

PRENATAL PLUS is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Apace Packaging, Llc. The primary component is Vitamin A Acetate; Cyanocobalamin; Ascorbic Acid; Cholecalciferol; Folic Acid; Thiamine Mononitrate; Riboflavin; Niacinamide; .alpha.-tocopherol Acetate, Dl-; .beta.-carotene; Zinc Oxide; Calcium Carbonate; Ferrous Fumarate; Pyridoxine Hydrochloride; Cupric Oxide.

• Product ID: 15338-522_6ce0c6be-4ba4-2dfd-e053-2a91aa0af597
• NDC: 15338-522
• Product Type: Human Prescription Drug
• Proprietary Name: PRENATAL PLUS
• Generic Name: Vitamin A Acetate, Beta Carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, Ferrous Fumarate, Zinc Oxide, Cupric Oxide
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2012-09-11
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: Apace Packaging, LLC
• Substance Name: VITAMIN A ACETATE; CYANOCOBALAMIN; ASCORBIC ACID; CHOLECALCIFEROL; FOLIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; .ALPHA.-TOCOPHEROL ACETATE, DL-; .BETA.-CAROTENE; ZINC OXIDE; CALCIUM CARBONATE; FERROUS FUMARATE; PYRIDOXINE HYDROCHLORIDE; CUPRIC OXIDE
• Active Ingredient Strength: 3080 [iU]/1; ug/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1
• Pharm Classes: Vitamin A [CS],Vitamin A [EPC],Vitamin B 12 [CS],Vitamin B12 [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Vitamin D [CS],Vitamin D [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 15338-522-10

100 TABLET, FILM COATED in 1 BOTTLE (15338-522-10)

• Marketing Start Date: 2017-07-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 15338-522-10 [15338052210]

PRENATAL PLUS TABLET, FILM COATED

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-07-19
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
VITAMIN A ACETATE	3080 [iU]/1

OpenFDA Data

• SPL SET ID: 6ce0c6be-4ba3-2dfd-e053-2a91aa0af597
• Manufacturer:
  • Apace Packaging, LLC
• UNII:
  • 25X51I8RD4
  • 1C6V77QF41
  • R5L488RY0Q
  • WR1WPI7EW8
  • PQ6CK8PD0R
  • 3LE3D9D6OY
  • V1XJQ704R4
  • 68Y4CF58BV
  • TLM2976OFR
  • 01YAE03M7J
  • SOI2LOH54Z
  • 8K0I04919X
  • 935E97BOY8
  • H0G9379FGK
  • P6YC3EG204

Pharmacological Class

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

NDC Crossover Matching brand name "PRENATAL PLUS" or generic name "Vitamin A Acetate, Beta Carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, Ferrous Fumarate, Zinc Oxide, Cupric Oxide"

NDC	Brand Name	Generic Name
10544-549	PRENATAL PLUS	VITAMIN A ACETATE, BETA CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN,
15338-522	PRENATAL PLUS	VITAMIN A ACETATE, BETA CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, FERROUS FUMARATE, ZINC OXIDE, CUPRIC OXIDE
17856-0668	PRENATAL PLUS	VITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, FERROUS FUMARATE, ZINC OXIDE, CUPRIC OXIDE
42291-686	PRENATAL PLUS	VITAMIN A ACETATE, BETA CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, FERROUS FUMARATE, ZINC OXIDE, CUPRIC OXIDE
42937-705	Prenatal Plus	Vitamin A, Ascorbic Acid, Cholecalciferol, .Alpha.-Tocopherol Acetate, Dl-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, Iron, Zinc Oxide, and Cupric Oxide
50268-677	PRENATAL PLUS	VITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, FERROUS FUMARATE, ZINC OXIDE, CUPRIC OXIDE
65162-668	PRENATAL PLUS	VITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, FERROUS FUMARATE, ZINC OXIDE, CUPRIC OXIDE
68151-2640	PRENATAL PLUS	VITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, FERROUS FUMARATE, ZINC OXIDE, CUPRIC OXIDE