FDA.reportPublic FDA data

VITAMIN D

Product NDC
51655-774
11-digit product format
516550774
Labeler code
51655
Product ID
51655-774_49739ebf-fa64-df44-e063-6294a90a2ea2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ergocalciferol
Dosage form
CAPSULE
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA090455
Marketing category
ANDA
Marketing start
2022-08-29
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
VITAMIN D
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-774-27VITAMIN D12 in 1 BOTTLE, PLASTICCAPSULE124
51655-774-52VITAMIN D30 in 1 BOTTLE, PLASTICCAPSULE304
51655-774-80VITAMIN D8 in 1 BOTTLE, PLASTICCAPSULE84

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-774VITAMIN D (ERGOCALCIFEROL) CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, 3 package rows20250101_f3402462-5d86-b4c9-e053-2a95a90aaab0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1367410ergocalciferol 1.25 MG (50,000 UNT) Oral CapsulePSNf3402462-5d86-b4c9-e053-2a95a90aaab04
1367410ergocalciferol 1.25 MG Oral CapsuleSCDf3402462-5d86-b4c9-e053-2a95a90aaab04
1367410vit-D 1.25 MG Oral CapsuleSYf3402462-5d86-b4c9-e053-2a95a90aaab04
1367410vitamin D 1.25 MG Oral CapsuleSYf3402462-5d86-b4c9-e053-2a95a90aaab04
1367410vitamin D2 1250 MCG Oral CapsuleSYf3402462-5d86-b4c9-e053-2a95a90aaab04
1367410vitamin D2 50,000 UNT Oral CapsuleSYf3402462-5d86-b4c9-e053-2a95a90aaab04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-774-275165507742712 CAPSULE in 1 BOTTLE, PLASTIC (51655-774-27) 12 capsule2022-09-21NoNoCurrent
51655-774-525165507745230 CAPSULE in 1 BOTTLE, PLASTIC (51655-774-52) 30 capsule2023-01-27NoNoCurrent
51655-774-80516550774808 CAPSULE in 1 BOTTLE, PLASTIC (51655-774-80) 8 capsule2022-08-29NoNoCurrent