PNV-DHA

Product NDC
42192-321
11-digit product format
421920321
Labeler code
42192
Product ID
42192-321_973ff5d8-ba4b-4641-a3a0-3840e4630ce3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine, folic acid, cyanocobalamin, calcium, ferrous fumarate, magnesium, doconexent
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Acella Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2009-11-02
Substance
.ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CALCIUM; CHOLECALCIFEROL; CYANOCOBALAMIN; DOCONEXENT; FERROUS FUMARATE; FOLIC ACID; MAGNESIUM; PYRIDOXINE
Active strength
10; 85; 140; 200; 12; 300; 27; 1; 45; 25 [iU]/1; [iU]/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; [iU]/1
Pharmacologic classes
Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calcium [CS], Calcium [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

Additional Listing Data#

Finished product
Yes
Brand name base
PNV-DHA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASCORBIC ACID10 [iU]/1
CHOLECALCIFEROL85 [iU]/1
.ALPHA.-TOCOPHEROL ACETATE, DL-140 mg/1
PYRIDOXINE200 [iU]/1
FOLIC ACID12 ug/1
CYANOCOBALAMIN300 mg/1
CALCIUM27 mg/1
FERROUS FUMARATE1 mg/1
MAGNESIUM45 mg/1
DOCONEXENT25 [iU]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PQ6CK8PD0RInternal UNII lookup
1C6V77QF41Internal UNII lookup
WR1WPI7EW8Internal UNII lookup
KV2JZ1BI6ZInternal UNII lookup
935E97BOY8Internal UNII lookup
P6YC3EG204Internal UNII lookup
SY7Q814VUPInternal UNII lookup
R5L488RY0QInternal UNII lookup
I38ZP9992AInternal UNII lookup
ZAD9OKH9JCInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
038fe2e7-dc16-485c-b5fb-746db7231347Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42192-321-30PNV-DHA30 in 1 BOTTLECAPSULE, GELATIN COATED303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42192-321-30EA - Each42192-32111021c7b-207e-4003-badd-f203b868b1b612013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
.ALPHA.-TOCOPHEROL ACETATE, DL-ACTIVE INGREDIENTWR1WPI7EW8PNV-DHA (ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENT) CAPSULE, GELATIN COATED [ACELLA PHARMACEUTICALS, LLC]1
ASCORBIC ACIDACTIVE INGREDIENTPQ6CK8PD0RPNV-DHA (ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENT) CAPSULE, GELATIN COATED [ACELLA PHARMACEUTICALS, LLC]1
CALCIUMACTIVE INGREDIENTSY7Q814VUPPNV-DHA (ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENT) CAPSULE, GELATIN COATED [ACELLA PHARMACEUTICALS, LLC]1
CHOLECALCIFEROLACTIVE INGREDIENT1C6V77QF41PNV-DHA (ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENT) CAPSULE, GELATIN COATED [ACELLA PHARMACEUTICALS, LLC]1
CYANOCOBALAMINACTIVE INGREDIENTP6YC3EG204PNV-DHA (ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENT) CAPSULE, GELATIN COATED [ACELLA PHARMACEUTICALS, LLC]1
DOCONEXENTACTIVE INGREDIENTZAD9OKH9JCPNV-DHA (ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENT) CAPSULE, GELATIN COATED [ACELLA PHARMACEUTICALS, LLC]1
FERROUS FUMARATEACTIVE INGREDIENTR5L488RY0QPNV-DHA (ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENT) CAPSULE, GELATIN COATED [ACELLA PHARMACEUTICALS, LLC]1
FOLIC ACIDACTIVE INGREDIENT935E97BOY8PNV-DHA (ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENT) CAPSULE, GELATIN COATED [ACELLA PHARMACEUTICALS, LLC]1
MAGNESIUMACTIVE INGREDIENTI38ZP9992APNV-DHA (ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENT) CAPSULE, GELATIN COATED [ACELLA PHARMACEUTICALS, LLC]1
PYRIDOXINEACTIVE INGREDIENTKV2JZ1BI6ZPNV-DHA (ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENT) CAPSULE, GELATIN COATED [ACELLA PHARMACEUTICALS, LLC]1
.ALPHA.-TOCOPHEROL, DL-ACTIVE MOIETY7QWA1RIO01PNV-DHA (ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENT) CAPSULE, GELATIN COATED [ACELLA PHARMACEUTICALS, LLC]1
ASCORBIC ACIDACTIVE MOIETYPQ6CK8PD0RPNV-DHA (ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENT) CAPSULE, GELATIN COATED [ACELLA PHARMACEUTICALS, LLC]1
CALCIUMACTIVE MOIETYSY7Q814VUPPNV-DHA (ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENT) CAPSULE, GELATIN COATED [ACELLA PHARMACEUTICALS, LLC]1
CHOLECALCIFEROLACTIVE MOIETY1C6V77QF41PNV-DHA (ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENT) CAPSULE, GELATIN COATED [ACELLA PHARMACEUTICALS, LLC]1
CYANOCOBALAMINACTIVE MOIETYP6YC3EG204PNV-DHA (ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENT) CAPSULE, GELATIN COATED [ACELLA PHARMACEUTICALS, LLC]1
DOCONEXENTACTIVE MOIETYZAD9OKH9JCPNV-DHA (ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENT) CAPSULE, GELATIN COATED [ACELLA PHARMACEUTICALS, LLC]1
FERROUS CATIONACTIVE MOIETYGW89581OWRPNV-DHA (ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENT) CAPSULE, GELATIN COATED [ACELLA PHARMACEUTICALS, LLC]1
FOLIC ACIDACTIVE MOIETY935E97BOY8PNV-DHA (ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENT) CAPSULE, GELATIN COATED [ACELLA PHARMACEUTICALS, LLC]1
MAGNESIUMACTIVE MOIETYI38ZP9992APNV-DHA (ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENT) CAPSULE, GELATIN COATED [ACELLA PHARMACEUTICALS, LLC]1
PYRIDOXINEACTIVE MOIETYKV2JZ1BI6ZPNV-DHA (ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENT) CAPSULE, GELATIN COATED [ACELLA PHARMACEUTICALS, LLC]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZPNV-DHA (ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENT) CAPSULE, GELATIN COATED [ACELLA PHARMACEUTICALS, LLC]1
CORN OILINACTIVE INGREDIENT8470G57WFMPNV-DHA (ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENT) CAPSULE, GELATIN COATED [ACELLA PHARMACEUTICALS, LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPNV-DHA (ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENT) CAPSULE, GELATIN COATED [ACELLA PHARMACEUTICALS, LLC]1
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYPNV-DHA (ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENT) CAPSULE, GELATIN COATED [ACELLA PHARMACEUTICALS, LLC]1
GELATININACTIVE INGREDIENT2G86QN327LPNV-DHA (ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENT) CAPSULE, GELATIN COATED [ACELLA PHARMACEUTICALS, LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPNV-DHA (ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENT) CAPSULE, GELATIN COATED [ACELLA PHARMACEUTICALS, LLC]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62PNV-DHA (ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENT) CAPSULE, GELATIN COATED [ACELLA PHARMACEUTICALS, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPNV-DHA (ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENT) CAPSULE, GELATIN COATED [ACELLA PHARMACEUTICALS, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RPNV-DHA (ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENT) CAPSULE, GELATIN COATED [ACELLA PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42192-321PNV-DHA (ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENT) CAPSULE, GELATIN COATED [ACELLA PHARMACEUTICALS, LLC]3Current NDC, Legacy NDC, 1 package rows20240116_038fe2e7-dc16-485c-b5fb-746db7231347.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
PNV-DHAASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENTAcella Pharmaceuticals, LLC038fe2e7-dc16-485c-b5fb-746db72313472026-07-23Boxed warning, Adverse reactionsExact identifier
ndc (product): 42192-321

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42192-321-304219203213030 CAPSULE, GELATIN COATED in 1 BOTTLE (42192-321-30) 2009-11-020000-00-00NoNoCurrent