FDA.reportPublic FDA data

Ergocalciferol

Product NDC
63629-7913
11-digit product format
636297913
Labeler code
63629
Product ID
63629-7913_6af02174-74f8-4298-ad23-fd3cffb93582
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ergocalciferol Capsules,
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204276
Marketing category
ANDA
Marketing start
2018-12-10
Substance
ERGOCALCIFEROL
Active strength
1.25 mg/1
Pharmacologic classes
Ergocalciferols [CS], Provitamin D2 Compound [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ergocalciferol
Listing expiration
2026-12-31

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
63629-7913-12025-03-25C16284748780-11030e365-509a-111a-e063-dadaa90a10e2Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units
63629-7913-22025-03-25C16284748780-11030e365-509a-111a-e063-dadaa90a10e2Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units
63629-7913-32025-03-25C16284748780-11030e365-509a-111a-e063-dadaa90a10e2Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units
63629-7913-12024-01-30C16284748780-11030e365-509a-111a-e063-dadaa90a10e2Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units
63629-7913-22024-01-30C16284748780-11030e365-509a-111a-e063-dadaa90a10e2Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units
63629-7913-32024-01-30C16284748780-11030e365-509a-111a-e063-dadaa90a10e2Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-7913-1Ergocalciferol90 in 1 BOTTLECAPSULE903
63629-7913-2Ergocalciferol40 in 1 BOTTLECAPSULE403
63629-7913-3Ergocalciferol20 in 1 BOTTLECAPSULE203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7913ERGOCALCIFEROL (ERGOCALCIFEROL CAPSULES,) CAPSULE [BRYANT RANCH PREPACK]3Current NDC, Legacy NDC, 3 package rows20250327_2cdd7f42-bc90-4b41-9936-acc7d9b79088.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1367410ergocalciferol 1.25 MG (50,000 UNT) Oral CapsulePSN2cdd7f42-bc90-4b41-9936-acc7d9b790883
1367410ergocalciferol 1.25 MG Oral CapsuleSCD2cdd7f42-bc90-4b41-9936-acc7d9b790883
1367410vit-D 1.25 MG Oral CapsuleSY2cdd7f42-bc90-4b41-9936-acc7d9b790883
1367410vitamin D 1.25 MG Oral CapsuleSY2cdd7f42-bc90-4b41-9936-acc7d9b790883
1367410vitamin D2 1250 MCG Oral CapsuleSY2cdd7f42-bc90-4b41-9936-acc7d9b790883
1367410vitamin D2 50,000 UNT Oral CapsuleSY2cdd7f42-bc90-4b41-9936-acc7d9b790883

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7913-16362979130190 CAPSULE in 1 BOTTLE (63629-7913-1) 90 capsule2022-02-220000-00-00NoNoCurrent
63629-7913-26362979130240 CAPSULE in 1 BOTTLE (63629-7913-2) 40 capsule2020-09-080000-00-00NoNoCurrent
63629-7913-36362979130320 CAPSULE in 1 BOTTLE (63629-7913-3) 20 capsule2022-02-220000-00-00NoNoCurrent