FDA.reportPublic FDA data

Zingiber

Product NDC
42546-300
11-digit product format
425460300
Labeler code
42546
Product ID
42546-300_3a11164d-6eb1-4a01-8722-0086f94a85b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pyridoxine, folic acid, calcium, and ginger tablet
Dosage form
TABLET
Route
ORAL
Labeler
PruGen, Inc. Pharmaceuticals
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2013-02-01
Marketing end
0000-00-00
Substance
PYRIDOXINE; FOLIC ACID; CALCIUM; GINGER
Active strength
40 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Calcium [CS],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Food Additives [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42546-300-602019-11-27C16284748780-19855d018-d511-cd31-e053-dbdaa90ab51aZingiber

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42546-300-60Zingiber60 in 1 BOTTLETABLET602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42546-300-60EA - Each42546-300cf92e390-4639-4c80-b6e7-b16efd4eb45f12013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCIUMACTIVE INGREDIENTSY7Q814VUPZINGIBER (PYRIDOXINE, FOLIC ACID, CALCIUM, AND GINGER TABLET) TABLET [PRUGEN, INC. PHARMACEUTICALS]2
FOLIC ACIDACTIVE INGREDIENT935E97BOY8ZINGIBER (PYRIDOXINE, FOLIC ACID, CALCIUM, AND GINGER TABLET) TABLET [PRUGEN, INC. PHARMACEUTICALS]2
GINGERACTIVE INGREDIENTC5529G5JPQZINGIBER (PYRIDOXINE, FOLIC ACID, CALCIUM, AND GINGER TABLET) TABLET [PRUGEN, INC. PHARMACEUTICALS]2
PYRIDOXINEACTIVE INGREDIENTKV2JZ1BI6ZZINGIBER (PYRIDOXINE, FOLIC ACID, CALCIUM, AND GINGER TABLET) TABLET [PRUGEN, INC. PHARMACEUTICALS]2
CALCIUMACTIVE MOIETYSY7Q814VUPZINGIBER (PYRIDOXINE, FOLIC ACID, CALCIUM, AND GINGER TABLET) TABLET [PRUGEN, INC. PHARMACEUTICALS]2
FOLIC ACIDACTIVE MOIETY935E97BOY8ZINGIBER (PYRIDOXINE, FOLIC ACID, CALCIUM, AND GINGER TABLET) TABLET [PRUGEN, INC. PHARMACEUTICALS]2
GINGERACTIVE MOIETYC5529G5JPQZINGIBER (PYRIDOXINE, FOLIC ACID, CALCIUM, AND GINGER TABLET) TABLET [PRUGEN, INC. PHARMACEUTICALS]2
PYRIDOXINEACTIVE MOIETYKV2JZ1BI6ZZINGIBER (PYRIDOXINE, FOLIC ACID, CALCIUM, AND GINGER TABLET) TABLET [PRUGEN, INC. PHARMACEUTICALS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZINGIBER (PYRIDOXINE, FOLIC ACID, CALCIUM, AND GINGER TABLET) TABLET [PRUGEN, INC. PHARMACEUTICALS]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ZINGIBER (PYRIDOXINE, FOLIC ACID, CALCIUM, AND GINGER TABLET) TABLET [PRUGEN, INC. PHARMACEUTICALS]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAZINGIBER (PYRIDOXINE, FOLIC ACID, CALCIUM, AND GINGER TABLET) TABLET [PRUGEN, INC. PHARMACEUTICALS]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PZINGIBER (PYRIDOXINE, FOLIC ACID, CALCIUM, AND GINGER TABLET) TABLET [PRUGEN, INC. PHARMACEUTICALS]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOZINGIBER (PYRIDOXINE, FOLIC ACID, CALCIUM, AND GINGER TABLET) TABLET [PRUGEN, INC. PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZINGIBER (PYRIDOXINE, FOLIC ACID, CALCIUM, AND GINGER TABLET) TABLET [PRUGEN, INC. PHARMACEUTICALS]2
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DZINGIBER (PYRIDOXINE, FOLIC ACID, CALCIUM, AND GINGER TABLET) TABLET [PRUGEN, INC. PHARMACEUTICALS]2
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UZINGIBER (PYRIDOXINE, FOLIC ACID, CALCIUM, AND GINGER TABLET) TABLET [PRUGEN, INC. PHARMACEUTICALS]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEZINGIBER (PYRIDOXINE, FOLIC ACID, CALCIUM, AND GINGER TABLET) TABLET [PRUGEN, INC. PHARMACEUTICALS]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ZINGIBER (PYRIDOXINE, FOLIC ACID, CALCIUM, AND GINGER TABLET) TABLET [PRUGEN, INC. PHARMACEUTICALS]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJZINGIBER (PYRIDOXINE, FOLIC ACID, CALCIUM, AND GINGER TABLET) TABLET [PRUGEN, INC. PHARMACEUTICALS]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APZINGIBER (PYRIDOXINE, FOLIC ACID, CALCIUM, AND GINGER TABLET) TABLET [PRUGEN, INC. PHARMACEUTICALS]2
TALCINACTIVE INGREDIENT7SEV7J4R1UZINGIBER (PYRIDOXINE, FOLIC ACID, CALCIUM, AND GINGER TABLET) TABLET [PRUGEN, INC. PHARMACEUTICALS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZINGIBER (PYRIDOXINE, FOLIC ACID, CALCIUM, AND GINGER TABLET) TABLET [PRUGEN, INC. PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42546-300ZINGIBER (PYRIDOXINE, FOLIC ACID, CALCIUM, AND GINGER TABLET) TABLET [PRUGEN, INC. PHARMACEUTICALS]2Legacy NDC, 1 package rows20130225_209da0f4-93d4-4690-9f07-7829334ce012.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42546-300-604254603006060 in 1 BOTTLEHistorical