FDA.reportPublic FDA data

Citranatal Harmony 2.1

Product NDC
0178-0797
11-digit product format
001780797
Labeler code
0178
Product ID
0178-0797_88dc0784-2854-b47f-e053-2a95a90ac51a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcium citrate, Iron pentacarbonyl, Cholecalciferol, .Alpha.-Tocopherol, Dl-, Pyridoxine hydrochloride, Folic Acid, Docusate Sodium, and Doconexent
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Mission Pharmacal Company
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2013-01-21
Marketing end
0000-00-00
Substance
CALCIUM CITRATE; IRON
Active strength
104 mg/1; mg/1
Pharmacologic classes
Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
910c1bd7-67d1-44c7-ad4f-9445f827edccProduct name120230808
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0178-0797-052021-01-29C16284748780-1ba0f9c33-44b2-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use CitraNatal Harmony ® safely and effectively. See full prescribing information for CitraNatal Harmony ® . CitraNatal Harmony ® (Calcium citrate, Iron pentacarbonyl, Cholecalciferol, .Alpha.-Tocopherol, Dl-, Pyridoxine hydrochloride, Folic Acid, Docusate Sodium, and Doconexent) capsules for oral use. Initial U.S. Approval: 2012
0178-0797-302021-01-29C16284748780-1ba0f9c33-44b2-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use CitraNatal Harmony ® safely and effectively. See full prescribing information for CitraNatal Harmony ® . CitraNatal Harmony ® (Calcium citrate, Iron pentacarbonyl, Cholecalciferol, .Alpha.-Tocopherol, Dl-, Pyridoxine hydrochloride, Folic Acid, Docusate Sodium, and Doconexent) capsules for oral use. Initial U.S. Approval: 2012

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0178-0797-05Citranatal Harmony 2.15 in 1 BOTTLECAPSULE, GELATIN COATED53
0178-0797-05Citranatal Harmony 2.11 in 1 CARTONCAPSULE, GELATIN COATED13
0178-0797-30Citranatal Harmony 2.130 in 1 BOTTLECAPSULE, GELATIN COATED303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0178-0797-30EA - Each0178-0797e6832705-013a-4d53-bd99-1565601c56d612013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCIUM CITRATEACTIVE INGREDIENTMLM29U2X85CITRANATAL HARMONY 2.1 (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM, AND DOCONEXENT) CAPSULE, GELATIN COATED [MISSION PHARMACAL COMPANY]1
IRONACTIVE INGREDIENTE1UOL152H7CITRANATAL HARMONY 2.1 (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM, AND DOCONEXENT) CAPSULE, GELATIN COATED [MISSION PHARMACAL COMPANY]1
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZBCITRANATAL HARMONY 2.1 (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM, AND DOCONEXENT) CAPSULE, GELATIN COATED [MISSION PHARMACAL COMPANY]1
IRONACTIVE MOIETYE1UOL152H7CITRANATAL HARMONY 2.1 (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM, AND DOCONEXENT) CAPSULE, GELATIN COATED [MISSION PHARMACAL COMPANY]1
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1CITRANATAL HARMONY 2.1 (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM, AND DOCONEXENT) CAPSULE, GELATIN COATED [MISSION PHARMACAL COMPANY]1
CHOLECALCIFEROLINACTIVE INGREDIENT1C6V77QF41CITRANATAL HARMONY 2.1 (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM, AND DOCONEXENT) CAPSULE, GELATIN COATED [MISSION PHARMACAL COMPANY]1
DOCONEXENTINACTIVE INGREDIENTZAD9OKH9JCCITRANATAL HARMONY 2.1 (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM, AND DOCONEXENT) CAPSULE, GELATIN COATED [MISSION PHARMACAL COMPANY]1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0CITRANATAL HARMONY 2.1 (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM, AND DOCONEXENT) CAPSULE, GELATIN COATED [MISSION PHARMACAL COMPANY]1
FOLIC ACIDINACTIVE INGREDIENT935E97BOY8CITRANATAL HARMONY 2.1 (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM, AND DOCONEXENT) CAPSULE, GELATIN COATED [MISSION PHARMACAL COMPANY]1
PYRIDOXINEINACTIVE INGREDIENTKV2JZ1BI6ZCITRANATAL HARMONY 2.1 (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM, AND DOCONEXENT) CAPSULE, GELATIN COATED [MISSION PHARMACAL COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0178-0797CITRANATAL HARMONY 2.1 (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM, AND DOCONEXENT) CAPSULE, GELATIN COATED [MISSION PHARMACAL COMPANY]3Legacy NDC, 3 package rows20190515_00ecf076-d840-bee7-38d1-48bae1066bff.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0178-0797-05001780797055 in 1 BOTTLEHistorical
0178-0797-300017807973030 in 1 BOTTLEHistorical