PNV-DHA

Product NDC
42192-323
11-digit product format
421920323
Labeler code
42192
Product ID
42192-323_4c39225d-b6a1-5de2-e063-6294a90aa552
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine, folic acid, calcium, ferrous fumarate, doconexent
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Acella Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2010-10-01
Marketing end
2027-03-31
Substance
.ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CALCIUM; CHOLECALCIFEROL; DOCONEXENT; FERROUS FUMARATE; FOLIC ACID; PYRIDOXINE
Active strength
30; 28; 160; 400; 300; 27; 1.25; 25 [iU]/1; mg/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calcium [CS], Calcium [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PNV-DHA

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASCORBIC ACID30 [iU]/1
CALCIUM28 mg/1
FERROUS FUMARATE160 mg/1
CHOLECALCIFEROL400 [iU]/1
.ALPHA.-TOCOPHEROL ACETATE, DL-300 mg/1
PYRIDOXINE27 mg/1
FOLIC ACID1.25 mg/1
DOCONEXENT25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PQ6CK8PD0RInternal UNII lookup
SY7Q814VUPInternal UNII lookup
R5L488RY0QInternal UNII lookup
1C6V77QF41Internal UNII lookup
WR1WPI7EW8Internal UNII lookup
KV2JZ1BI6ZInternal UNII lookup
935E97BOY8Internal 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
576e8bbb-1625-493c-85da-43caf2f02e3cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42192-323-30PNV-DHA30 in 1 BOTTLECAPSULE, GELATIN COATED304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42192-323-30EA - Each42192-323560ec12f-69ba-41a0-b494-99af945ee1ad12018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42192-323PNV-DHA (ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CALCIUM, FERROUS FUMARATE, DOCONEXENT) CAPSULE, GELATIN COATED [ACELLA PHARMACEUTICALS, LLC]3Current NDC, Legacy NDC, 1 package rows20240116_576e8bbb-1625-493c-85da-43caf2f02e3c.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, CALCIUM, FERROUS FUMARATE, DOCONEXENTAcella Pharmaceuticals, LLC576e8bbb-1625-493c-85da-43caf2f02e3c2026-03-04Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (product): 42192-323

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42192-323-304219203233030 CAPSULE, GELATIN COATED in 1 BOTTLE (42192-323-30) 2010-10-012027-03-31NoNoCurrent