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NDC 13925-0116-01 Se-Natal 19 30; 1000; 100; 200; 7; 400; 12; 25; 29; 1; 15; 20; 3; 3; 20 mg/1; [iU]/1; mg/1; mg/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Details

Se-Natal 19 30; 1000; 100; 200; 7; 400; 12; 25; 29; 1; 15; 20; 3; 3; 20 mg/1; [iU]/1; mg/1; mg/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1

Se-Natal 19 is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Seton Pharmaceuticals. The primary component is .ALPHA.-TOCOPHEROL ACETATE, DL-; .BETA.-CAROTENE; ASCORBIC ACID; CALCIUM CARBONATE; CALCIUM PANTOTHENATE; CHOLECALCIFEROL; CYANOCOBALAMIN; DOCUSATE SODIUM; FERROUS FUMARATE; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE; ZINC OXI.

Product Information

NDC	13925-0116
Product ID	13925-116_92e3f27a-65d2-4e92-a3f1-eabd70531b48
Associated GPIs	78512070000330
GCN Sequence Number	080464
GCN Sequence Number Description	PNV 119/iron fum/folic acid TABLET 29 MG-1 MG ORAL
HIC3	C6F
HIC3 Description	PRENATAL VITAMIN PREPARATIONS
GCN	47316
HICL Sequence Number	046205
HICL Sequence Number Description	PRENATAL VITAMINS NO.119/IRON FUMARATE/FOLIC ACID
Brand/Generic	Brand
Proprietary Name	Se-Natal 19
Proprietary Name Suffix	n/a
Non-Proprietary Name	.beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium pantothenate, calcium carbonate, ferrous fumarate, zinc oxide and docusate s
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	30; 1000; 100; 200; 7; 400; 12; 25; 29; 1; 15; 20; 3; 3; 20
Active Ingredient Units	mg/1; [iU]/1; mg/1; mg/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1
Substance Name	.ALPHA.-TOCOPHEROL ACETATE, DL-; .BETA.-CAROTENE; ASCORBIC ACID; CALCIUM CARBONATE; CALCIUM PANTOTHENATE; CHOLECALCIFEROL; CYANOCOBALAMIN; DOCUSATE SODIUM; FERROUS FUMARATE; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE; ZINC OXI
Labeler Name	Seton Pharmaceuticals
Pharmaceutical Class	Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Vitam
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2023-12-31

Package

Package Images

NDC 13925-0116-01 (13925011601)

Pricing Information
NDC Package Code	13925-116-01
Billing NDC	13925011601
Package	100 TABLET in 1 BOTTLE (13925-116-01)
Marketing Start Date	2009-07-01
NDC Exclude Flag	N
Price Per Unit	0.43223
Pricing Unit	EA
Effective Date	2024-01-24
NDC Description	SE-NATAL-19 TABLET
Pharmacy Type Indicator	C/I
OTC	N
Explanation Code	4
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 635104e6-6a53-4684-ac9a-7ac31b33083d Details

SPL UNCLASSIFIED SECTION

Vitamins & Minerals with Folic Acid

Rx Only

DESCRIPTION

Se-Natal 19 is a white, oblong, film coated tablet, debossed "TL 019". Each film coated tablet contains:

Supplement Facts
Servings per Bottle: 100
Serving Size: 1 tablet
Each Tablet contains:		% DV for Pregnant and Lactating Women
Vitamin A (as beta carotene)	1000 IU	23%
Vitamin C (ascorbic acid)	100 mg	83%
Vitamin D (as cholecalciferol)	10 mcg	67%
Vitamin E (as dl-alpha tocoperol acetate)	30 IU	142%
Thiamine (Vitamin B1)	3 mg	214%
Riboflavin (Vitamin B2)	3 mg	188%
Niacin (as niacinamide)	15 mg	83%
Vitamin B6 (as pyridoxine HCl)	20 mg	1000%
Folate (folic acid)	1000 mcg	167%
Vitamin B12 (as cyanocobalamin)	12 mcg	429%
Pantothenic Acid (as calcium pantothenate)	7 mg	100%
Calcium (as calcium carbonate)	200 mg	15%
Iron (as ferrous fumarate)	29 mg	107%
Zinc (as zinc oxide)	20 mg	154%

OTHER INGREDIENTS

Acacia, Croscarmellose Sodium, Fumed Silica, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Stearic Acid, Talc and Titanium Dioxide.

INDICATIONS

Se-Natal 19 tablets are indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and non-lactating mothers. Se-Natal 19 tablets are also useful in improving the nutritional status of women prior to conception.

CONTRAINDICATIONS

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

WARNINGS

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

PRECAUTIONS

General

Take 2 hours after meals. Do not exceed recommended dose. Discontinue use if symptoms of intolerance appear.

Folic Acid

Folic acid in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Dosing for elderly patients should be cautious. Due to the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy, dosing should start at the lower end of the dosing range.

ADVERSE REACTIONS

Adverse reactions with iron therapy may include GI irritation, constipation, diarrhea, nausea, vomiting, and dark stools. Adverse reactions with iron therapy are usually transient. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

DRUG INTERACTIONS

Prescriber should be aware of a number of iron/drug interactions, including antacids, tetracyclines, or fluoroquinolones.

OVERDOSAGE

Symptoms:

Abdominal pain, metabolic acidosis, anuria, CNS damage, coma, convulsions, death, dehydration, diffuse vascular congestion, hepatic cirrhosis, hypotension, hypothermia, lethargy, nausea, vomiting, diarrhea, tarry stools, melena, hematemesis, tachycardia, hyperglycemia, drowsiness, pallor, cyanosis, lassitude, seizures, and shock.

DOSAGE AND ADMINISTRATION

One tablet daily, or as directed by a physician.

NOTICE

Contact with moisture can discolor or erode the tablet. Do not chew tablet.

HOW SUPPLIED

Se-Natal 19 tablets for oral administration are supplied as white, coated, oblong tablets debossed "TL019", packaged in bottles of 100 tablets.

Product Code: 13925-116-01.

STORAGE

Store at 20° - 25°C (68° - 77°F), excursions permitted to 15° - 30°C (59° - 86°F) [See USP controlled room temperature].

PHARMACIST

Dispense in a tight, light-resistant container as defined in the USP/NF with child-resistant closure.

Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SPL UNCLASSIFIED SECTION

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician's supervision. There are no implied or explicit claims on therapeutic equivalence.

Reserved for Professional Recommendation.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Rx Only

Manufactured For:

Seton Pharmaceuticals

Manasquan, NJ 08736

1-800-510-3401

MADE IN CANADA

Code 116-01

Rev. 03/18

SETON PHARMACEUTICALS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 13925-116-01

Se-Natal 19

Tablets

Vitamins and Minerals with Folic Acid

100 Tablets

Rx Only

SETON

PHARMACEUTICALS

INGREDIENTS AND APPEARANCE

SE-NATAL 19

.beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium pantothenate, calcium carbonate, ferrous fumarate, zinc oxide and docusate sodium tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:13925-116
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
.BETA.-CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J)	.BETA.-CAROTENE	1000 [iU]
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	100 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01)	.ALPHA.-TOCOPHEROL, DL-	30 mg
THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE	3 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	3 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	15 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	20 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	12 ug
CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737)	PANTOTHENIC ACID	7 mg
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	200 mg
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	29 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	20 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	25 mg

Ingredient Name	Strength
Inactive Ingredients
ACACIA (UNII: 5C5403N26O)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL (UNII: 532B59J990)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code	TL019
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13925-116-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2009

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		07/01/2009

Labeler - Seton Pharmaceuticals (828898002)

Registrant - Seton Pharmaceuticals (828898002)

Revised: 5/2022

Document Id: 92e3f27a-65d2-4e92-a3f1-eabd70531b48

Set id: 635104e6-6a53-4684-ac9a-7ac31b33083d

Version: 6

Effective Time: 20220522

Search by Drug Name or NDC

NDC 13925-0116-01 Se-Natal 19 30; 1000; 100; 200; 7; 400; 12; 25; 29; 1; 15; 20; 3; 3; 20 mg/1; [iU]/1; mg/1; mg/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Details

Se-Natal 19 30; 1000; 100; 200; 7; 400; 12; 25; 29; 1; 15; 20; 3; 3; 20 mg/1; [iU]/1; mg/1; mg/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1

Product Information

Package

Package Images

NDC 13925-0116-01 (13925011601)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 635104e6-6a53-4684-ac9a-7ac31b33083d Details

SPL UNCLASSIFIED SECTION

DESCRIPTION

OTHER INGREDIENTS

INDICATIONS

CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

General

Folic Acid

Pediatric Use

Geriatric Use

ADVERSE REACTIONS

DRUG INTERACTIONS

OVERDOSAGE

Symptoms:

DOSAGE AND ADMINISTRATION

NOTICE

HOW SUPPLIED

STORAGE

PHARMACIST

SPL UNCLASSIFIED SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

Plavix (Clopidogrel) With Olive Oil Dosing Question

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NDC 13925-0116-01 Se-Natal 19 30; 1000; 100; 200; 7; 400; 12; 25; 29; 1; 15; 20; 3; 3; 20 mg/1; [iU]/1; mg/1; mg/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Details

Se-Natal 19 30; 1000; 100; 200; 7; 400; 12; 25; 29; 1; 15; 20; 3; 3; 20 mg/1; [iU]/1; mg/1; mg/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1

Product Information

Package

Package Images

NDC 13925-0116-01 (13925011601)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 635104e6-6a53-4684-ac9a-7ac31b33083d Details

SPL UNCLASSIFIED SECTION

DESCRIPTION

OTHER INGREDIENTS

INDICATIONS

CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

General

Folic Acid

​Pediatric Use

​Geriatric Use

​ADVERSE REACTIONS

DRUG INTERACTIONS

OVERDOSAGE

​Symptoms:

DOSAGE AND ADMINISTRATION

​NOTICE

​HOW SUPPLIED

STORAGE

PHARMACIST

SPL UNCLASSIFIED SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

Pediatric Use

Geriatric Use

ADVERSE REACTIONS

Symptoms:

NOTICE

HOW SUPPLIED