FDA.reportPublic FDA data

Ergocalciferol Capsules,

Product NDC
68788-4042
11-digit product format
687884042
Labeler code
68788
Product ID
68788-4042_eefdca6e-e5b7-4323-aa92-e0bb8275947d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ergocalciferol Capsules,
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA204276
Marketing category
ANDA
Marketing start
2025-10-17
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 Capsules,
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-4042-1Ergocalciferol Capsules,100 in 1 BOTTLECAPSULE1001
68788-4042-2Ergocalciferol Capsules,12 in 1 BOTTLECAPSULE121
68788-4042-3Ergocalciferol Capsules,30 in 1 BOTTLECAPSULE301
68788-4042-8Ergocalciferol Capsules,8 in 1 BOTTLECAPSULE81

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-4042-1EA - Each68788-4042cccebaf3-fcbe-44d3-a370-644d67a56f0512026-01-08
68788-4042-2EA - Each68788-4042b1a2306c-41d2-44f3-b2b1-9623596d563e12026-01-08
68788-4042-3EA - Each68788-4042d12bae00-24db-418f-87c6-f78e9ed1bd7412026-01-08
68788-4042-8EA - Each68788-4042df99698b-a134-4f16-a96a-1ca6e9ae884912026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1367410ergocalciferol 1.25 MG (50,000 UNT) Oral CapsulePSNeefdca6e-e5b7-4323-aa92-e0bb8275947d1
1367410ergocalciferol 1.25 MG Oral CapsuleSCDeefdca6e-e5b7-4323-aa92-e0bb8275947d1
1367410vit-D 1.25 MG Oral CapsuleSYeefdca6e-e5b7-4323-aa92-e0bb8275947d1
1367410vitamin D 1.25 MG Oral CapsuleSYeefdca6e-e5b7-4323-aa92-e0bb8275947d1
1367410vitamin D2 1250 MCG Oral CapsuleSYeefdca6e-e5b7-4323-aa92-e0bb8275947d1
1367410vitamin D2 50,000 UNT Oral CapsuleSYeefdca6e-e5b7-4323-aa92-e0bb8275947d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-4042-168788404201100 CAPSULE in 1 BOTTLE (68788-4042-1) 100 capsule2025-10-17NoNoCurrent
68788-4042-26878840420212 CAPSULE in 1 BOTTLE (68788-4042-2) 12 capsule2025-10-17NoNoCurrent
68788-4042-36878840420330 CAPSULE in 1 BOTTLE (68788-4042-3) 30 capsule2025-10-17NoNoCurrent
68788-4042-8687884042088 CAPSULE in 1 BOTTLE (68788-4042-8) 8 capsule2025-10-17NoNoCurrent