MedPath

Select OB

SELECT-OB Chewable Caplets Prenatal Supplement

Approved
Approval ID

adc77b02-a00f-430b-ae61-f89387b6fe3b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 21, 2014

Manufacturers
FDA

Everett Laboratories, Inc.

DUNS: 071170534

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

.BETA.-CAROTENE, VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, COBALAMIN, IRON, MAGNESIUM OXIDE, and ZINC OXIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0642-0120
Product Classification
G
Generic Name
.BETA.-CAROTENE, VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, COBALAMIN, IRON, MAGNESIUM OXIDE, and ZINC OXIDE
Product Specifications
Route of AdministrationORAL
Effective DateJuly 21, 2014
FDA Product Classification

INGREDIENTS (38)

VITAMIN A ACETATEActive
Quantity: 1100 [iU] in 1 1
Code: 3LE3D9D6OY
Classification: ACTIM
.BETA.-CAROTENEActive
Quantity: 600 [iU] in 1 1
Code: 01YAE03M7J
Classification: ACTIB
CHOLECALCIFEROLActive
Quantity: 400 [iU] in 1 1
Code: 1C6V77QF41
Classification: ACTIB
ASCORBIC ACIDActive
Quantity: 60 mg in 1 1
Code: PQ6CK8PD0R
Classification: ACTIB
RIBOFLAVINActive
Quantity: 1.8 mg in 1 1
Code: TLM2976OFR
Classification: ACTIB
THIAMINE MONONITRATEActive
Quantity: 1.6 mg in 1 1
Code: 8K0I04919X
Classification: ACTIR
NIACINAMIDEActive
Quantity: 15 mg in 1 1
Code: 25X51I8RD4
Classification: ACTIB
FOLIC ACIDActive
Quantity: 0.4 mg in 1 1
Code: 935E97BOY8
Classification: ACTIB
IRONActive
Quantity: 29 mg in 1 1
Code: E1UOL152H7
Classification: ACTIB
PYRIDOXINE HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 1
Code: 68Y4CF58BV
Classification: ACTIB
LEVOMEFOLATE CALCIUMActive
Quantity: 0.6 mg in 1 1
Code: A9R10K3F2F
Classification: ACTIB
COBALAMINActive
Quantity: 5 ug in 1 1
Code: 8406EY2OQA
Classification: ACTIB
MAGNESIUM OXIDEActive
Quantity: 25 mg in 1 1
Code: 3A3U0GI71G
Classification: ACTIB
ZINC OXIDEActive
Quantity: 15 mg in 1 1
Code: SOI2LOH54Z
Classification: ACTIB
FRUCTOSEInactive
Code: 6YSS42VSEV
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MALIC ACIDInactive
Code: 817L1N4CKP
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROXYPROPYL CELLULOSE (TYPE H)Inactive
Code: RFW2ET671P
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SODIUM ASCORBATEInactive
Code: S033EH8359
Classification: IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
.ALPHA.-TOCOPHEROL, DL-Inactive
Code: 7QWA1RIO01
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATE, DL-Active
Quantity: 30 [iU] in 1 1
Code: WR1WPI7EW8
Classification: ACTIM

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Select OB - FDA Drug Approval Details