FDA.reportPublic FDA data

VITAMIN D

Product NDC
71610-552
11-digit product format
716100552
Labeler code
71610
Product ID
71610-552_43fa081c-eeee-05fb-e063-6394a90a1610
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ergocalciferol
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA090455
Marketing category
ANDA
Marketing start
2014-05-16
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
VITAMIN D
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ERGOCALCIFEROL1.25 mg/1

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
71610-552-03VITAMIN D3 in 1 BOTTLE, PLASTICCAPSULE35
71610-552-04VITAMIN D4 in 1 BOTTLE, PLASTICCAPSULE45
71610-552-08VITAMIN D8 in 1 BOTTLE, PLASTICCAPSULE85
71610-552-12VITAMIN D12 in 1 BOTTLE, PLASTICCAPSULE125
71610-552-13VITAMIN D13 in 1 BOTTLE, PLASTICCAPSULE135
71610-552-47VITAMIN D24 in 1 BOTTLE, PLASTICCAPSULE245
71610-552-68VITAMIN D26 in 1 BOTTLE, PLASTICCAPSULE265

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-552-03EA - Each71610-55200321e3f-9cc1-4cc8-97b8-a5adfe8217e412024-08-12
71610-552-04EA - Each71610-5528889fb73-b8a9-4572-84be-28c9af50040112021-08-05
71610-552-08EA - Each71610-55244d61e55-6ca0-41dd-a64e-5d478ca352de12025-02-10
71610-552-13EA - Each71610-5526ae99430-0b7e-4ac6-953f-6cbd68be4f6012023-10-16
71610-552-47EA - Each71610-552ac79f57c-e123-4baf-992c-3c7903693bb912025-12-16
71610-552-68EA - Each71610-55258fbc8bb-abce-40e5-b36e-fbf20eeec5d712025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-552VITAMIN D (ERGOCALCIFEROL) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4Current NDC, Legacy NDC, 7 package rows20241115_3c0f4142-cc1f-43de-8677-ee06b6f4fc10.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1367410ergocalciferol 1.25 MG (50,000 UNT) Oral CapsulePSN3c0f4142-cc1f-43de-8677-ee06b6f4fc105
1367410ergocalciferol 1.25 MG Oral CapsuleSCD3c0f4142-cc1f-43de-8677-ee06b6f4fc105
1367410vit-D 1.25 MG Oral CapsuleSY3c0f4142-cc1f-43de-8677-ee06b6f4fc105
1367410vitamin D 1.25 MG Oral CapsuleSY3c0f4142-cc1f-43de-8677-ee06b6f4fc105
1367410vitamin D2 1250 MCG Oral CapsuleSY3c0f4142-cc1f-43de-8677-ee06b6f4fc105
1367410vitamin D2 50,000 UNT Oral CapsuleSY3c0f4142-cc1f-43de-8677-ee06b6f4fc105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-552-03716100552033 CAPSULE in 1 BOTTLE, PLASTIC (71610-552-03) 3 capsule2024-06-20NoNoCurrent
71610-552-04716100552044 CAPSULE in 1 BOTTLE, PLASTIC (71610-552-04) 4 capsule2021-05-040000-00-00NoNoCurrent
71610-552-06716100552066 CAPSULE in 1 BOTTLE, PLASTIC (71610-552-06)6 capsule2026-06-160Current
71610-552-08716100552088 CAPSULE in 1 BOTTLE, PLASTIC (71610-552-08) 8 capsule2024-11-12NoNoCurrent
71610-552-09716100552099 CAPSULE in 1 BOTTLE, PLASTIC (71610-552-09)9 capsule2026-06-160Current
71610-552-127161005521212 CAPSULE in 1 BOTTLE, PLASTIC (71610-552-12) 12 capsule2021-05-040000-00-00NoNoCurrent
71610-552-137161005521313 CAPSULE in 1 BOTTLE, PLASTIC (71610-552-13) 13 capsule2023-08-25NoNoCurrent
71610-552-257161005522525 CAPSULE in 1 BOTTLE, PLASTIC (71610-552-25)25 capsule2026-06-160Current
71610-552-477161005524724 CAPSULE in 1 BOTTLE, PLASTIC (71610-552-47) 24 capsule2025-11-19NoNoCurrent
71610-552-49716100552495 CAPSULE in 1 BOTTLE, PLASTIC (71610-552-49)5 capsule2026-06-160Current
71610-552-687161005526826 CAPSULE in 1 BOTTLE, PLASTIC (71610-552-68) 26 capsule2025-11-19NoNoCurrent