Prenaissance

Product NDC
42192-341
11-digit product format
421920341
Labeler code
42192
Product ID
42192-341_221c7f55-aba5-4377-9d6e-499cc29e54c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM and DOCONEXENT
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Acella Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-06-13
Marketing end
0000-00-00
Substance
ASCORBIC ACID; TRICALCIUM PHOSPHATE; FERROUS FUMARATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL, D-; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; DOCONEXENT; DOCUSATE SODIUM
Active strength
28 mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Vitamin C [EPC],Ascorbic Acid [CS],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS],Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42192-341DDiscontinued by firm2026-10-12
excluded packagepackage42192-34142192-341-30DDiscontinued by firm2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42192-341-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42192-341-30f5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42192-341-30EA - Each42192-341da318935-466b-4d04-9548-2358b7e4b65412013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
.ALPHA.-TOCOPHEROL, D-ACTIVE INGREDIENTN9PR3490H9PRENAISSANCE (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM AND DOCONEXENT) CAPSULE, LIQUID FILLED [ACELLA PHARMACEUTICALS, LLC]1
ASCORBIC ACIDACTIVE INGREDIENTPQ6CK8PD0RPRENAISSANCE (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM AND DOCONEXENT) CAPSULE, LIQUID FILLED [ACELLA PHARMACEUTICALS, LLC]1
CHOLECALCIFEROLACTIVE INGREDIENT1C6V77QF41PRENAISSANCE (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM AND DOCONEXENT) CAPSULE, LIQUID FILLED [ACELLA PHARMACEUTICALS, LLC]1
DOCONEXENTACTIVE INGREDIENTZAD9OKH9JCPRENAISSANCE (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM AND DOCONEXENT) CAPSULE, LIQUID FILLED [ACELLA PHARMACEUTICALS, LLC]1
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0PRENAISSANCE (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM AND DOCONEXENT) CAPSULE, LIQUID FILLED [ACELLA PHARMACEUTICALS, LLC]1
FERROUS FUMARATEACTIVE INGREDIENTR5L488RY0QPRENAISSANCE (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM AND DOCONEXENT) CAPSULE, LIQUID FILLED [ACELLA PHARMACEUTICALS, LLC]1
FOLIC ACIDACTIVE INGREDIENT935E97BOY8PRENAISSANCE (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM AND DOCONEXENT) CAPSULE, LIQUID FILLED [ACELLA PHARMACEUTICALS, LLC]1
PYRIDOXINE HYDROCHLORIDEACTIVE INGREDIENT68Y4CF58BVPRENAISSANCE (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM AND DOCONEXENT) CAPSULE, LIQUID FILLED [ACELLA PHARMACEUTICALS, LLC]1
TRICALCIUM PHOSPHATEACTIVE INGREDIENTK4C08XP666PRENAISSANCE (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM AND DOCONEXENT) CAPSULE, LIQUID FILLED [ACELLA PHARMACEUTICALS, LLC]1
.ALPHA.-TOCOPHEROL, D-ACTIVE MOIETYN9PR3490H9PRENAISSANCE (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM AND DOCONEXENT) CAPSULE, LIQUID FILLED [ACELLA PHARMACEUTICALS, LLC]1
ASCORBIC ACIDACTIVE MOIETYPQ6CK8PD0RPRENAISSANCE (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM AND DOCONEXENT) CAPSULE, LIQUID FILLED [ACELLA PHARMACEUTICALS, LLC]1
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZBPRENAISSANCE (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM AND DOCONEXENT) CAPSULE, LIQUID FILLED [ACELLA PHARMACEUTICALS, LLC]1
CHOLECALCIFEROLACTIVE MOIETY1C6V77QF41PRENAISSANCE (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM AND DOCONEXENT) CAPSULE, LIQUID FILLED [ACELLA PHARMACEUTICALS, LLC]1
DOCONEXENTACTIVE MOIETYZAD9OKH9JCPRENAISSANCE (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM AND DOCONEXENT) CAPSULE, LIQUID FILLED [ACELLA PHARMACEUTICALS, LLC]1
DOCUSATEACTIVE MOIETYM7P27195AGPRENAISSANCE (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM AND DOCONEXENT) CAPSULE, LIQUID FILLED [ACELLA PHARMACEUTICALS, LLC]1
FERROUS CATIONACTIVE MOIETYGW89581OWRPRENAISSANCE (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM AND DOCONEXENT) CAPSULE, LIQUID FILLED [ACELLA PHARMACEUTICALS, LLC]1
FOLIC ACIDACTIVE MOIETY935E97BOY8PRENAISSANCE (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM AND DOCONEXENT) CAPSULE, LIQUID FILLED [ACELLA PHARMACEUTICALS, LLC]1
PYRIDOXINEACTIVE MOIETYKV2JZ1BI6ZPRENAISSANCE (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM AND DOCONEXENT) CAPSULE, LIQUID FILLED [ACELLA PHARMACEUTICALS, LLC]1
ETHYL VANILLININACTIVE INGREDIENTYC9ST449YJPRENAISSANCE (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM AND DOCONEXENT) CAPSULE, LIQUID FILLED [ACELLA PHARMACEUTICALS, LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPRENAISSANCE (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM AND DOCONEXENT) CAPSULE, LIQUID FILLED [ACELLA PHARMACEUTICALS, LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPRENAISSANCE (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM AND DOCONEXENT) CAPSULE, LIQUID FILLED [ACELLA PHARMACEUTICALS, LLC]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MPRENAISSANCE (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM AND DOCONEXENT) CAPSULE, LIQUID FILLED [ACELLA PHARMACEUTICALS, LLC]1
GELATININACTIVE INGREDIENT2G86QN327LPRENAISSANCE (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM AND DOCONEXENT) CAPSULE, LIQUID FILLED [ACELLA PHARMACEUTICALS, LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPRENAISSANCE (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM AND DOCONEXENT) CAPSULE, LIQUID FILLED [ACELLA PHARMACEUTICALS, LLC]1
SOYBEAN OILINACTIVE INGREDIENT241ATL177APRENAISSANCE (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM AND DOCONEXENT) CAPSULE, LIQUID FILLED [ACELLA PHARMACEUTICALS, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPRENAISSANCE (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM AND DOCONEXENT) CAPSULE, LIQUID FILLED [ACELLA PHARMACEUTICALS, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RPRENAISSANCE (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM AND DOCONEXENT) CAPSULE, LIQUID FILLED [ACELLA PHARMACEUTICALS, LLC]1
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VPRENAISSANCE (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM AND DOCONEXENT) CAPSULE, LIQUID FILLED [ACELLA PHARMACEUTICALS, LLC]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42192-341-304219203413030 CAPSULE, LIQUID FILLED in 1 CAPSULE (42192-341-30) 2011-06-130000-00-00NoNoCurrent