FDA.reportPublic FDA data

VITAMIN D

Product NDC
70518-1878
11-digit product format
705181878
Labeler code
70518
Product ID
70518-1878_4978ba98-7454-79ea-e063-6394a90ac7f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ergocalciferol
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090455
Marketing category
ANDA
Marketing start
2019-02-18
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-1878-02023-03-07C16284748780-1f386c64a-0dd6-0266-e053-dadaa90a7c1aVITAMIN D (Ergocalciferol Capsules, USP) 1.25mg (50,000 USP Units) Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units.
70518-1878-02023-03-07C16284748780-1f386c64a-0dd6-0266-e053-dadaa90a7c1aVITAMIN D (Ergocalciferol Capsules, USP) 1.25mg (50,000 USP Units) Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units.
70518-1878-12023-03-07C16284748780-1f386c64a-0dd6-0266-e053-dadaa90a7c1aVITAMIN D (Ergocalciferol Capsules, USP) 1.25mg (50,000 USP Units) Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units.
70518-1878-12023-03-07C16284748780-1f386c64a-0dd6-0266-e053-dadaa90a7c1aVITAMIN D (Ergocalciferol Capsules, USP) 1.25mg (50,000 USP Units) Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units.
70518-1878-22023-03-07C16284748780-1f386c64a-0dd6-0266-e053-dadaa90a7c1aVITAMIN D (Ergocalciferol Capsules, USP) 1.25mg (50,000 USP Units) Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units.
70518-1878-22023-03-07C16284748780-1f386c64a-0dd6-0266-e053-dadaa90a7c1aVITAMIN D (Ergocalciferol Capsules, USP) 1.25mg (50,000 USP Units) Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units.
70518-1878-32023-03-07C16284748780-1f386c64a-0dd6-0266-e053-dadaa90a7c1aVITAMIN D (Ergocalciferol Capsules, USP) 1.25mg (50,000 USP Units) Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units.
70518-1878-32023-03-07C16284748780-1f386c64a-0dd6-0266-e053-dadaa90a7c1aVITAMIN D (Ergocalciferol Capsules, USP) 1.25mg (50,000 USP Units) Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units.
70518-1878-42023-03-07C16284748780-1f386c64a-0dd6-0266-e053-dadaa90a7c1aVITAMIN D (Ergocalciferol Capsules, USP) 1.25mg (50,000 USP Units) Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units.
70518-1878-42023-03-07C16284748780-1f386c64a-0dd6-0266-e053-dadaa90a7c1aVITAMIN D (Ergocalciferol Capsules, USP) 1.25mg (50,000 USP Units) Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units.
70518-1878-02023-01-30C16284748780-1f386c64a-0dd6-0266-e053-dadaa90a7c1aVITAMIN D (Ergocalciferol Capsules, USP) 1.25mg (50,000 USP Units) Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units.
70518-1878-02023-01-30C16284748780-1f386c64a-0dd6-0266-e053-dadaa90a7c1aVITAMIN D (Ergocalciferol Capsules, USP) 1.25mg (50,000 USP Units) Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units.
70518-1878-12023-01-30C16284748780-1f386c64a-0dd6-0266-e053-dadaa90a7c1aVITAMIN D (Ergocalciferol Capsules, USP) 1.25mg (50,000 USP Units) Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units.
70518-1878-12023-01-30C16284748780-1f386c64a-0dd6-0266-e053-dadaa90a7c1aVITAMIN D (Ergocalciferol Capsules, USP) 1.25mg (50,000 USP Units) Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units.
70518-1878-22023-01-30C16284748780-1f386c64a-0dd6-0266-e053-dadaa90a7c1aVITAMIN D (Ergocalciferol Capsules, USP) 1.25mg (50,000 USP Units) Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units.
70518-1878-22023-01-30C16284748780-1f386c64a-0dd6-0266-e053-dadaa90a7c1aVITAMIN D (Ergocalciferol Capsules, USP) 1.25mg (50,000 USP Units) Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units.
70518-1878-32023-01-30C16284748780-1f386c64a-0dd6-0266-e053-dadaa90a7c1aVITAMIN D (Ergocalciferol Capsules, USP) 1.25mg (50,000 USP Units) Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units.
70518-1878-32023-01-30C16284748780-1f386c64a-0dd6-0266-e053-dadaa90a7c1aVITAMIN D (Ergocalciferol Capsules, USP) 1.25mg (50,000 USP Units) Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units.
70518-1878-42023-01-30C16284748780-1f386c64a-0dd6-0266-e053-dadaa90a7c1aVITAMIN D (Ergocalciferol Capsules, USP) 1.25mg (50,000 USP Units) Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units.
70518-1878-42023-01-30C16284748780-1f386c64a-0dd6-0266-e053-dadaa90a7c1aVITAMIN D (Ergocalciferol Capsules, USP) 1.25mg (50,000 USP Units) Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-1878-0VITAMIN D4 in 1 BOTTLE, PLASTICCAPSULE415
70518-1878-1VITAMIN D12 in 1 BOTTLE, PLASTICCAPSULE1215
70518-1878-2VITAMIN D12 in 1 BLISTER PACKCAPSULE1215
70518-1878-3VITAMIN D4 in 1 BLISTER PACKCAPSULE415
70518-1878-4VITAMIN D30 in 1 BOTTLE, PLASTICCAPSULE3015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1878VITAMIN D (ERGOCALCIFEROL) CAPSULE [REMEDYREPACK INC.]12Current NDC, Legacy NDC, 5 package rows20250328_3fe92511-0b4a-43f4-9c89-c8599469c1e2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1367410ergocalciferol 1.25 MG (50,000 UNT) Oral CapsulePSN3fe92511-0b4a-43f4-9c89-c8599469c1e215
1367410ergocalciferol 1.25 MG Oral CapsuleSCD3fe92511-0b4a-43f4-9c89-c8599469c1e215
1367410vit-D 1.25 MG Oral CapsuleSY3fe92511-0b4a-43f4-9c89-c8599469c1e215
1367410vitamin D 1.25 MG Oral CapsuleSY3fe92511-0b4a-43f4-9c89-c8599469c1e215
1367410vitamin D2 1250 MCG Oral CapsuleSY3fe92511-0b4a-43f4-9c89-c8599469c1e215
1367410vitamin D2 50,000 UNT Oral CapsuleSY3fe92511-0b4a-43f4-9c89-c8599469c1e215

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1878-0705181878004 CAPSULE in 1 BOTTLE, PLASTIC (70518-1878-0) 4 capsule2019-02-180000-00-00NoNoCurrent
70518-1878-17051818780112 CAPSULE in 1 BOTTLE, PLASTIC (70518-1878-1) 12 capsule2019-08-280000-00-00NoNoCurrent
70518-1878-27051818780212 CAPSULE in 1 BLISTER PACK (70518-1878-2) 12 capsule2021-03-170000-00-00NoNoCurrent
70518-1878-3705181878034 CAPSULE in 1 BLISTER PACK (70518-1878-3) 4 capsule2021-03-170000-00-00NoNoCurrent
70518-1878-47051818780430 CAPSULE in 1 BOTTLE, PLASTIC (70518-1878-4) 30 capsule2021-12-060000-00-00NoNoCurrent