PNV-DHA

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Acella Pharmaceuticals, LLC

Labeler

Acella Pharmaceuticals, LLC

DUNS Number

825380939

Products1

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

Product Details

NDC Product Code

42192-323

Route of Administration

ORAL

Effective Date

September 11, 2018

Ingredients

GELATIN TYPE B BOVINE (230 BLOOM)Inactive

Code: WIL1404U79Class: IACT

GLYCERINInactive

Code: PDC6A3C0OXClass: IACT

SOYBEAN OILInactive

Code: 241ATL177AClass: IACT

LECITHIN, SOYBEANInactive

Code: 1DI56QDM62Class: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

YELLOW WAXInactive

Code: 2ZA36H0S2VClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

ORANGEInactive

Code: 5EVU04N5QUClass: IACT

ETHYL VANILLINInactive

Code: YC9ST449YJClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

Vitamin CActive

Code: PQ6CK8PD0RClass: ACTIBQuantity: 28 mg in 1 1

CalciumActive

Code: SY7Q814VUPClass: ACTIBQuantity: 160 mg in 1 1

Ferrous fumarateActive

Code: R5L488RY0QClass: ACTIMQuantity: 27 mg in 1 1

Vitamin D3Active

Code: 1C6V77QF41Class: ACTIBQuantity: 400 [iU] in 1 1

PyridoxineActive

Code: KV2JZ1BI6ZClass: ACTIBQuantity: 25 mg in 1 1

Folic acidActive

Code: 935E97BOY8Class: ACTIBQuantity: 1.25 mg in 1 1

DoconexentActive

Code: ZAD9OKH9JCClass: ACTIBQuantity: 300 mg in 1 1

DL-alpha tocopheryl acetateActive

Code: WR1WPI7EW8Class: ACTIMQuantity: 30 [iU] in 1 1

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PNV-DHA

FDA Approval Summary

Manufacturing Establishments1

Products1

PNV-DHA

Product Details