FDA.reportPublic FDA data

Ergocalciferol

Product NDC
68071-1951
11-digit product format
680711951
Labeler code
68071
Product ID
68071-1951_50b2cfc7-dfe3-4406-e063-6294a90a2527
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ergocalciferol
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA080704
Marketing category
ANDA
Marketing start
2016-06-15
Substance
ERGOCALCIFEROL
Active strength
1.25 mg/1
Pharmacologic classes
Ergocalciferols [CS], Provitamin D2 Compound [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ERGOCALCIFEROL1.25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVS041H42XC
Rxcui1367410

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
a1367f07-14a3-4895-a6e7-61ee9285308bProduct name120190415
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-1951-42023-07-14C16284748780-1ba0f9c33-25c0-a910-e053-dadaa90a0b85Ergocalciferol Capsules, USP
68071-1951-82023-07-14C16284748780-1ba0f9c33-25c0-a910-e053-dadaa90a0b85Ergocalciferol Capsules, USP
68071-1951-92023-07-14C16284748780-1ba0f9c33-25c0-a910-e053-dadaa90a0b85Ergocalciferol Capsules, USP
68071-1951-42023-01-30C16284748780-1ba0f9c33-25c0-a910-e053-dadaa90a0b85Ergocalciferol Capsules, USP
68071-1951-82023-01-30C16284748780-1ba0f9c33-25c0-a910-e053-dadaa90a0b85Ergocalciferol Capsules, USP
68071-1951-92023-01-30C16284748780-1ba0f9c33-25c0-a910-e053-dadaa90a0b85Ergocalciferol Capsules, USP
68071-1951-42021-02-23C16284748780-1ba0f9c33-25c0-a910-e053-dadaa90a0b85Ergocalciferol Capsules, USP
68071-1951-82021-02-23C16284748780-1ba0f9c33-25c0-a910-e053-dadaa90a0b85Ergocalciferol Capsules, USP
68071-1951-92021-02-23C16284748780-1ba0f9c33-25c0-a910-e053-dadaa90a0b85Ergocalciferol Capsules, USP
68071-1951-42021-01-29C16284748780-1ba0f9c33-25c0-a910-e053-dadaa90a0b85Ergocalciferol Capsules, USP
68071-1951-82021-01-29C16284748780-1ba0f9c33-25c0-a910-e053-dadaa90a0b85Ergocalciferol Capsules, USP
68071-1951-92021-01-29C16284748780-1ba0f9c33-25c0-a910-e053-dadaa90a0b85Ergocalciferol Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-1951-2Ergocalciferol12 in 1 BOTTLECAPSULE, LIQUID FILLED1210
68071-1951-4Ergocalciferol4 in 1 BOTTLECAPSULE, LIQUID FILLED410
68071-1951-8Ergocalciferol8 in 1 BOTTLECAPSULE, LIQUID FILLED810
68071-1951-9Ergocalciferol94 in 1 BOTTLECAPSULE, LIQUID FILLED9410

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-1951ERGOCALCIFEROL CAPSULE, LIQUID FILLED [NUCARE PHARMACEUTICALS, INC.]9Current NDC, Legacy NDC, 4 package rows20241120_492452d6-2b32-39c0-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1367410ergocalciferol 1.25 MG (50,000 UNT) Oral CapsulePSN492452d6-2b32-39c0-e054-00144ff8d46c10
1367410ergocalciferol 1.25 MG Oral CapsuleSCD492452d6-2b32-39c0-e054-00144ff8d46c10
1367410vit-D 1.25 MG Oral CapsuleSY492452d6-2b32-39c0-e054-00144ff8d46c10
1367410vitamin D 1.25 MG Oral CapsuleSY492452d6-2b32-39c0-e054-00144ff8d46c10
1367410vitamin D2 1250 MCG Oral CapsuleSY492452d6-2b32-39c0-e054-00144ff8d46c10
1367410vitamin D2 50,000 UNT Oral CapsuleSY492452d6-2b32-39c0-e054-00144ff8d46c10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-1951-26807119510212 CAPSULE, LIQUID FILLED in 1 BOTTLE (68071-1951-2) 2017-10-11NoNoCurrent
68071-1951-4680711951044 CAPSULE, LIQUID FILLED in 1 BOTTLE (68071-1951-4) 2017-02-220000-00-00NoNoCurrent
68071-1951-8680711951088 CAPSULE, LIQUID FILLED in 1 BOTTLE (68071-1951-8) 2017-02-220000-00-00NoNoCurrent
68071-1951-96807119510994 CAPSULE, LIQUID FILLED in 1 BOTTLE (68071-1951-9) 2017-10-110000-00-00NoNoCurrent