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NDC 65162-0668-50 PRENATAL PLUS 22; 120; 920; 200; 400; 2; 12; 27; 1; 20; 10; 3; 1.84; 3080; 25 mg/1; mg/1; [iU]/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1 Details

PRENATAL PLUS 22; 120; 920; 200; 400; 2; 12; 27; 1; 20; 10; 3; 1.84; 3080; 25 mg/1; mg/1; [iU]/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1

PRENATAL PLUS is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals LLC. The primary component is .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; BETA CAROTENE; CALCIUM CARBONATE; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A ACETATE; ZINC.

Product Information

NDC	65162-0668
Product ID	65162-668_0d4bdd65-75d3-49a5-b8ce-485696664dc3
Associated GPIs	78512015000324
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	PRENATAL PLUS
Proprietary Name Suffix	n/a
Non-Proprietary 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, CUPR
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	22; 120; 920; 200; 400; 2; 12; 27; 1; 20; 10; 3; 1.84; 3080; 25
Active Ingredient Units	mg/1; mg/1; [iU]/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1
Substance Name	.ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; BETA CAROTENE; CALCIUM CARBONATE; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A ACETATE; ZINC
Labeler Name	Amneal Pharmaceuticals LLC
Pharmaceutical Class	Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingr
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2023-12-31

Package

Package Images

NDC 65162-0668-50 (65162066850)

Pricing Information	N/A
NDC Package Code	65162-668-50
Billing NDC	65162066850
Package	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (65162-668-50)
Marketing Start Date	2009-12-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 12151d1c-4306-4e77-86e5-a0ee7f81d3cd Details

DESCRIPTION

Each Tablet Contains:

VITAMINS: Amount per Tablet

Vitamin A (from Acetate and Beta Carotene) ............................. 4000 IU

Vitamin C (Ascorbic Acid) ........................................................... 120 mg

Vitamin D-3 (Cholecalciferol) ....................................................... 400 IU

Vitamin E (dl- Alpha Tocopheryl Acetate) ...................................... 22 mg

Thiamine (Vitamin B-1) (from Thiamine Mononitrate) ................. 1.84 mg

Riboflavin (Vitamin B-2) .................................................................. 3 mg

Niacin (as Niacinamide) ................................................................ 20 mg

Vitamin B-6 (Pyridoxine HCl) ......................................................... 10 mg

Folic Acid ......................................................................................... 1 mg

Vitamin B-12 (Cyanocobalamin) ................................................... 12 mcg

MINERALS: Amount per Tablet

Calcium (as Calcium Carbonate) ................................................. 200 mg

Iron (from Ferrous Fumarate) ........................................................ 27 mg

Zinc (from Zinc Oxide) ................................................................... 25 mg

Copper (from Cupric Oxide) ........................................................... 2 mg

Other ingredients: croscarmellose sodium, FD&C Blue #2, FD&C Red #40, FD&C Yellow # 5, FD&C Yellow # 6, macrogol, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, silicon, starch, stearic acid, talc, titanium dioxide

INDICATIONS AND USAGE

To provide Vitamin and Mineral supplementation throughout pregnancy and during the postnatal period for both the lactating and non-lactating mother. It is also useful for improving nutritional status prior to conception.

WARNINGS

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under age 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or Poison Control Center immediately.

PRECAUTIONS

Folic acid may partially correct the hematological damage due to Vitamin B12 deficiency of pernicious anemia, while the associated neurological damage progesses.

DOSAGE AND ADMINISTRATION

As a dietary adjunct before, during and after pregnancy, take one tablet daily with a meal, or as directed by a physician.

HOW SUPPLIED

Bottles of 100: NDC 65162-668-10

Bottles of 500: NDC 65162-668-50

Storage

STORE AT CONTROLLED ROOM TEMPERATURE 15º to 30ºC (59º to 86ºF), AVOID EXCESS HEAT.

Dispense in a well closed light-resistant container, with a child resistant cap.

KEEP THIS AND ALL MEDICATION OUR OF THE REACH OF CHILDREN.

DO NOT USE IF INNER SAFETY SEAL IS BROKEN OR MISSING.

Manufactured by:

Nexgen Pharma

Colorado Springs, CO 80905

Distributed by:

Amneal Pharmaceuticals

Glasgow, KY 42141

Rev. 09-2012

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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 tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65162-668
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T)	VITAMIN A	3080 [iU]
BETA CAROTENE (UNII: 01YAE03M7J) (BETA CAROTENE - UNII:01YAE03M7J)	BETA CAROTENE	920 [iU]
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	120 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01)	.ALPHA.-TOCOPHEROL, DL-	22 mg
THIAMINE MONONITRATE (UNII: 8K0I04919X) (Thiamine ION - UNII:4ABT0J945J)	THIAMINE	1.84 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	3 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	20 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	10 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	12 ug
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	200 mg
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	27 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	25 mg
CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L)	CUPRIC CATION	2 mg

Ingredient Name	Strength
Inactive Ingredients
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM ASCORBATE (UNII: S033EH8359)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBIC ACID (UNII: X045WJ989B)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCROSE (UNII: C151H8M554)
SUNFLOWER OIL (UNII: 3W1JG795YI)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	yellow	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	G12
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65162-668-10	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/02/2009
2	NDC:65162-668-50	500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/02/2009

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		12/02/2009

Labeler - Amneal Pharmaceuticals LLC (123797875)

Name	Address	ID/FEI	Business Operations
Establishment
New Generation Wellness		806784679	analysis(65162-668) , manufacture(65162-668)

Revised: 3/2022

Document Id: 0d4bdd65-75d3-49a5-b8ce-485696664dc3

Set id: 12151d1c-4306-4e77-86e5-a0ee7f81d3cd

Version: 19

Effective Time: 20220329