FDA.reportPublic FDA data

Ergocalciferol

Product NDC
50090-5844
11-digit product format
500905844
Labeler code
50090
Product ID
50090-5844_4f025ab1-b3f3-4fe1-bd25-cc218fba7c52
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ergocalciferol Capsules,
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
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
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
50090-5844-12023-02-07C16284748780-1f386c649-9bb2-0266-e053-dadaa90a7c1aVitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units
50090-5844-12023-02-07C16284748780-1f386c649-9bb2-0266-e053-dadaa90a7c1aVitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units
50090-5844-12023-02-07C16284748780-1f386c649-9bb2-0266-e053-dadaa90a7c1aVitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units
50090-5844-22023-02-07C16284748780-1f386c649-9bb2-0266-e053-dadaa90a7c1aVitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units
50090-5844-22023-02-07C16284748780-1f386c649-9bb2-0266-e053-dadaa90a7c1aVitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units
50090-5844-22023-02-07C16284748780-1f386c649-9bb2-0266-e053-dadaa90a7c1aVitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units
50090-5844-32023-02-07C16284748780-1f386c649-9bb2-0266-e053-dadaa90a7c1aVitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units
50090-5844-32023-02-07C16284748780-1f386c649-9bb2-0266-e053-dadaa90a7c1aVitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units
50090-5844-32023-02-07C16284748780-1f386c649-9bb2-0266-e053-dadaa90a7c1aVitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units
50090-5844-12023-01-30C16284748780-1f386c649-9bb2-0266-e053-dadaa90a7c1aVitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units
50090-5844-12023-01-30C16284748780-1f386c649-9bb2-0266-e053-dadaa90a7c1aVitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units
50090-5844-12023-01-30C16284748780-1f386c649-9bb2-0266-e053-dadaa90a7c1aVitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units
50090-5844-22023-01-30C16284748780-1f386c649-9bb2-0266-e053-dadaa90a7c1aVitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units
50090-5844-22023-01-30C16284748780-1f386c649-9bb2-0266-e053-dadaa90a7c1aVitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units
50090-5844-22023-01-30C16284748780-1f386c649-9bb2-0266-e053-dadaa90a7c1aVitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units
50090-5844-32023-01-30C16284748780-1f386c649-9bb2-0266-e053-dadaa90a7c1aVitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units
50090-5844-32023-01-30C16284748780-1f386c649-9bb2-0266-e053-dadaa90a7c1aVitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units
50090-5844-32023-01-30C16284748780-1f386c649-9bb2-0266-e053-dadaa90a7c1aVitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5844-1Ergocalciferol8 in 1 BOTTLECAPSULE89
50090-5844-2Ergocalciferol4 in 1 BOTTLECAPSULE49
50090-5844-3Ergocalciferol12 in 1 BOTTLECAPSULE129

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5844-1EA - Each50090-58441dd0a123-c7ef-414b-beac-98fdd428987312022-06-06
50090-5844-2EA - Each50090-58441931b1a3-fc46-469c-a902-15173ba6c34e12022-06-06
50090-5844-3EA - Each50090-5844af3291d6-4252-472e-ac2c-35caf8fdcadd12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5844ERGOCALCIFEROL (ERGOCALCIFEROL CAPSULES,) CAPSULE [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 3 package rows20231125_d9d45422-b7a2-4f8a-a00d-2754f8b26dd1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1367410ergocalciferol 1.25 MG (50,000 UNT) Oral CapsulePSNd9d45422-b7a2-4f8a-a00d-2754f8b26dd19
1367410ergocalciferol 1.25 MG Oral CapsuleSCDd9d45422-b7a2-4f8a-a00d-2754f8b26dd19
1367410vit-D 1.25 MG Oral CapsuleSYd9d45422-b7a2-4f8a-a00d-2754f8b26dd19
1367410vitamin D 1.25 MG Oral CapsuleSYd9d45422-b7a2-4f8a-a00d-2754f8b26dd19
1367410vitamin D2 1250 MCG Oral CapsuleSYd9d45422-b7a2-4f8a-a00d-2754f8b26dd19
1367410vitamin D2 50,000 UNT Oral CapsuleSYd9d45422-b7a2-4f8a-a00d-2754f8b26dd19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5844-1500905844018 CAPSULE in 1 BOTTLE (50090-5844-1) 8 capsule2021-11-030000-00-00NoNoCurrent
50090-5844-2500905844024 CAPSULE in 1 BOTTLE (50090-5844-2) 4 capsule2021-11-030000-00-00NoNoCurrent
50090-5844-35009058440312 CAPSULE in 1 BOTTLE (50090-5844-3) 12 capsule2021-11-030000-00-00NoNoCurrent