FDA.reportPublic FDA data

Prenatal Plus Vitamins

Product NDC
39328-106
Requested package NDC
39328-106-10
11-digit product format
393280106
Labeler code
39328
Product ID
39328-106_3ca7c2e1-8af0-48ae-893a-8f4e06eac6a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prenatal with ferrous fumarate and folic acid
Dosage form
TABLET
Route
ORAL
Labeler
Patrin Pharma, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2013-04-01
Substance
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
Active strength
924; 276; 120; 10; 10; 1.84; 3; 20; 10; 1667; 12; 200; 27; 25; 2 ug/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
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/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Prenatal Plus Vitamins
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VITAMIN A ACETATE924 ug/1
BETA CAROTENE276 ug/1
ASCORBIC ACID120 mg/1
CHOLECALCIFEROL10 ug/1
.ALPHA.-TOCOPHEROL ACETATE, DL-10 mg/1
THIAMINE MONONITRATE1.84 mg/1
RIBOFLAVIN3 mg/1
NIACINAMIDE20 mg/1
PYRIDOXINE HYDROCHLORIDE10 mg/1
FOLIC ACID1667 ug/1
CYANOCOBALAMIN12 ug/1
CALCIUM CARBONATE200 mg/1
FERROUS FUMARATE27 mg/1
ZINC OXIDE25 mg/1
CUPRIC OXIDE2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 15 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3LE3D9D6OYInternal UNII lookup
01YAE03M7JInternal UNII lookup
PQ6CK8PD0RInternal UNII lookup
1C6V77QF41Internal UNII lookup
WR1WPI7EW8Internal UNII lookup
8K0I04919XInternal UNII lookup
TLM2976OFRInternal UNII lookup
25X51I8RD4Internal UNII lookup
68Y4CF58BVInternal UNII lookup
935E97BOY8Internal UNII lookup
P6YC3EG204Internal UNII lookup
H0G9379FGKInternal UNII lookup
R5L488RY0QInternal UNII lookup
SOI2LOH54ZInternal UNII lookup
V1XJQ704R4Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
59c5c1a4-3f42-441a-b842-903f9bab346fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
910c1bd7-67d1-44c7-ad4f-9445f827edccProduct name120230808
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
e2dae634-14ed-febf-08ee-93196433b5b7Product name920190614
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
d394f843-7479-dc48-dbd3-232266c5548cProduct name120140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
39328-106-10Prenatal Plus Vitamins100 in 1 BOTTLE, PLASTICTABLET1003
39328-106-50Prenatal Plus Vitamins500 in 1 BOTTLE, PLASTICTABLET5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
39328-106-10EA - Each39328-106f7a4b752-043d-4e8c-9e22-562606df749812013-07-02
39328-106-50EA - Each39328-106ad2ea590-9335-491b-af0b-28c3b864f77912014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
.ALPHA.-TOCOPHEROL ACETATE, DL-ACTIVE INGREDIENTWR1WPI7EW8PRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
ASCORBIC ACIDACTIVE INGREDIENTPQ6CK8PD0RPRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
BETA CAROTENEACTIVE INGREDIENT01YAE03M7JPRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
CALCIUM CARBONATEACTIVE INGREDIENTH0G9379FGKPRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
CHOLECALCIFEROLACTIVE INGREDIENT1C6V77QF41PRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
COPPERACTIVE INGREDIENT789U1901C5PRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
CYANOCOBALAMINACTIVE INGREDIENTP6YC3EG204PRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
FOLIC ACIDACTIVE INGREDIENT935E97BOY8PRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
IRONACTIVE INGREDIENTE1UOL152H7PRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
NIACINACTIVE INGREDIENT2679MF687APRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
PYRIDOXINE HYDROCHLORIDEACTIVE INGREDIENT68Y4CF58BVPRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
RIBOFLAVINACTIVE INGREDIENTTLM2976OFRPRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
THIAMINEACTIVE INGREDIENTX66NSO3N35PRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
VITAMIN A ACETATEACTIVE INGREDIENT3LE3D9D6OYPRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
ZINCACTIVE INGREDIENTJ41CSQ7QDSPRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
.ALPHA.-TOCOPHEROL, DL-ACTIVE MOIETY7QWA1RIO01PRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
ASCORBIC ACIDACTIVE MOIETYPQ6CK8PD0RPRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
BETA CAROTENEACTIVE MOIETY01YAE03M7JPRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZBPRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
CHOLECALCIFEROLACTIVE MOIETY1C6V77QF41PRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
COPPERACTIVE MOIETY789U1901C5PRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
CYANOCOBALAMINACTIVE MOIETYP6YC3EG204PRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
FOLIC ACIDACTIVE MOIETY935E97BOY8PRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
IRONACTIVE MOIETYE1UOL152H7PRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
NIACINACTIVE MOIETY2679MF687APRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
PYRIDOXINEACTIVE MOIETYKV2JZ1BI6ZPRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
RIBOFLAVINACTIVE MOIETYTLM2976OFRPRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
THIAMINE IONACTIVE MOIETY4ABT0J945JPRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
VITAMIN AACTIVE MOIETY81G40H8B0TPRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
ZINCACTIVE MOIETYJ41CSQ7QDSPRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
.ALPHA.-TOCOPHEROL, DL-INACTIVE INGREDIENT7QWA1RIO01PRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
ACACIAINACTIVE INGREDIENT5C5403N26OPRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0NPRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2PRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BPRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4PRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DPRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
METHYLCELLULOSE (100 MPA.S)INACTIVE INGREDIENT4GFU244C4JPRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPPRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BPRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
SOY PROTEININACTIVE INGREDIENTR44IWB3RN5PRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554PRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1
TRICALCIUM PHOSPHATEINACTIVE INGREDIENTK4C08XP666PRENATAL VITAMINS PLUS LOW IRON (PRENATAL WITH FERROUS FUM AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
39328-106PRENATAL PLUS VITAMINS (PRENATAL WITH FERROUS FUMARATE AND FOLIC ACID) TABLET [PATRIN PHARMA, INC.]3Current NDC, Legacy NDC, 2 package rows20220120_59c5c1a4-3f42-441a-b842-903f9bab346f.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Prenatal Plus VitaminsPRENATAL WITH FERROUS FUMARATE AND FOLIC ACIDPatrin Pharma, Inc.59c5c1a4-3f42-441a-b842-903f9bab346f2022-01-13Boxed warningExact identifier
ndc (package): 39328-106-10
ndc (product): 39328-106
ndc11 (package): 39328010610

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
39328-106-1039328010610100 TABLET in 1 BOTTLE, PLASTIC (39328-106-10) 100 tablet2013-04-010000-00-00NoNoCurrent