Ergocalciferol

Product NDC
69452-151
11-digit product format
694520151
Labeler code
69452
Product ID
69452-151_44ea5b7f-37c7-ed1d-e063-6294a90ab33f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ergocalciferol
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Bionpharma Inc.
Application
ANDA080704
Marketing category
ANDA
Marketing start
2016-06-15
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A080704-001VITAMIN DERGOCALCIFEROL50,000 IUCAPSULE / ORALAAApproved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A080704-001AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A080704-001VITAMIN D50,000 IUCAPSULE / ORALAAApproved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A080704-001AA1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ErgocalciferolERGOCALCIFEROLREMEDYREPACK INC.a80436e0-b507-4e7b-9a60-a9d5ddc4a0452026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080704
application number: ANDA080704
ErgocalciferolERGOCALCIFEROLBryant Ranch Prepack0d230fd8-2ea7-4dd6-a506-5f7804e539fc2026-05-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080704
application number: ANDA080704
ErgocalciferolERGOCALCIFEROLBryant Ranch Prepackc4793165-6647-4dba-b100-3986739cd01e2026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080704
application number: ANDA080704
ErgocalciferolERGOCALCIFEROLBryant Ranch Prepack39b72d09-cedc-4130-89a3-1ea03f58ba042026-05-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080704
application number: ANDA080704
ErgocalciferolERGOCALCIFEROLSt. Mary's Medical Park Pharmacy5f4ef344-7880-3375-e053-2a91aa0a47b82026-05-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080704
application number: ANDA080704
ErgocalciferolERGOCALCIFEROLPD-Rx Pharmaceuticals, Inc.2475e731-0072-4787-8a40-09137883c6252026-05-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080704
application number: ANDA080704
ErgocalciferolERGOCALCIFEROLNuCare Pharmaceuticals, Inc.492452d6-2b32-39c0-e054-00144ff8d46c2026-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080704
application number: ANDA080704
ErgocalciferolERGOCALCIFEROLPreferred Pharmaceuticals Inc.1cd4afc6-ef90-4e7b-9f11-2bfbd137524c2026-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080704
application number: ANDA080704
ErgocalciferolERGOCALCIFEROLAvKAREf55eafcd-dfd9-fdae-c39f-ae07aa852ce12025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080704
application number: ANDA080704
ErgocalciferolERGOCALCIFEROLBionpharma Inc.2a8d73d6-9991-401b-ab8b-81f22e5a06952025-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080704
application number: ANDA080704
ndc (product): 69452-151
Vitamin DVITAMIN DDirectRX84647b52-3c4c-31bb-e053-2991aa0a8a7e2025-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080704
application number: ANDA080704
ErgocalciferolERGOCALCIFEROLAphena Pharma Solutions - Tennessee, LLCc538ac91-2507-4f42-8f7a-013510539b302024-05-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080704
application number: ANDA080704
ErgocalciferolERGOCALCIFEROLBryant Ranch Prepack9e63d720-cce8-4a59-b311-26cfca1139572024-04-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080704
application number: ANDA080704
ErgocalciferolERGOCALCIFEROLAphena Pharma Solutions - Tennessee, LLC2841b0ba-3b09-4f03-a060-9fb7f1af83442018-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080704
application number: ANDA080704

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
VS041H42XCInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1367410Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2a8d73d6-9991-401b-ab8b-81f22e5a0695Available on FDA.report

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
69452-151-20Ergocalciferol100 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69452-151-20EA - Each69452-1510126c1f8-038e-4f90-a635-5bed4ed4696b12016-07-19

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-151ERGOCALCIFEROL CAPSULE, LIQUID FILLED [BIONPHARMA INC.]6Current NDC, Legacy NDC, 1 package rows20241222_2a8d73d6-9991-401b-ab8b-81f22e5a0695.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1367410ergocalciferol 1.25 MG (50,000 UNT) Oral CapsulePSN0d230fd8-2ea7-4dd6-a506-5f7804e539fc103
1367410ergocalciferol 1.25 MG Oral CapsuleSCD0d230fd8-2ea7-4dd6-a506-5f7804e539fc103
1367410vit-D 1.25 MG Oral CapsuleSY0d230fd8-2ea7-4dd6-a506-5f7804e539fc103
1367410vitamin D 1.25 MG Oral CapsuleSY0d230fd8-2ea7-4dd6-a506-5f7804e539fc103
1367410vitamin D2 1250 MCG Oral CapsuleSY0d230fd8-2ea7-4dd6-a506-5f7804e539fc103
1367410vitamin D2 50,000 UNT Oral CapsuleSY0d230fd8-2ea7-4dd6-a506-5f7804e539fc103
1367410ergocalciferol 1.25 MG (50,000 UNT) Oral CapsulePSNa80436e0-b507-4e7b-9a60-a9d5ddc4a04523
1367410ergocalciferol 1.25 MG Oral CapsuleSCDa80436e0-b507-4e7b-9a60-a9d5ddc4a04523
1367410vit-D 1.25 MG Oral CapsuleSYa80436e0-b507-4e7b-9a60-a9d5ddc4a04523
1367410vitamin D 1.25 MG Oral CapsuleSYa80436e0-b507-4e7b-9a60-a9d5ddc4a04523
1367410vitamin D2 1250 MCG Oral CapsuleSYa80436e0-b507-4e7b-9a60-a9d5ddc4a04523
1367410vitamin D2 50,000 UNT Oral CapsuleSYa80436e0-b507-4e7b-9a60-a9d5ddc4a04523
1367410ergocalciferol 1.25 MG (50,000 UNT) Oral CapsulePSN2475e731-0072-4787-8a40-09137883c62519
1367410ergocalciferol 1.25 MG Oral CapsuleSCD2475e731-0072-4787-8a40-09137883c62519
1367410vit-D 1.25 MG Oral CapsuleSY2475e731-0072-4787-8a40-09137883c62519
1367410vitamin D 1.25 MG Oral CapsuleSY2475e731-0072-4787-8a40-09137883c62519
1367410vitamin D2 1250 MCG Oral CapsuleSY2475e731-0072-4787-8a40-09137883c62519
1367410vitamin D2 50,000 UNT Oral CapsuleSY2475e731-0072-4787-8a40-09137883c62519
1367410ergocalciferol 1.25 MG (50,000 UNT) Oral CapsulePSN39b72d09-cedc-4130-89a3-1ea03f58ba0412
1367410ergocalciferol 1.25 MG Oral CapsuleSCD39b72d09-cedc-4130-89a3-1ea03f58ba0412
1367410vit-D 1.25 MG Oral CapsuleSY39b72d09-cedc-4130-89a3-1ea03f58ba0412
1367410vitamin D 1.25 MG Oral CapsuleSY39b72d09-cedc-4130-89a3-1ea03f58ba0412
1367410vitamin D2 1250 MCG Oral CapsuleSY39b72d09-cedc-4130-89a3-1ea03f58ba0412
1367410vitamin D2 50,000 UNT Oral CapsuleSY39b72d09-cedc-4130-89a3-1ea03f58ba0412
1367410ergocalciferol 1.25 MG (50,000 UNT) Oral CapsulePSN492452d6-2b32-39c0-e054-00144ff8d46c10
1367410ergocalciferol 1.25 MG Oral CapsuleSCD492452d6-2b32-39c0-e054-00144ff8d46c10
1367410vit-D 1.25 MG Oral CapsuleSY492452d6-2b32-39c0-e054-00144ff8d46c10
1367410vitamin D 1.25 MG Oral CapsuleSY492452d6-2b32-39c0-e054-00144ff8d46c10
1367410vitamin D2 1250 MCG Oral CapsuleSY492452d6-2b32-39c0-e054-00144ff8d46c10
1367410vitamin D2 50,000 UNT Oral CapsuleSY492452d6-2b32-39c0-e054-00144ff8d46c10
1367410ergocalciferol 1.25 MG (50,000 UNT) Oral CapsulePSNf55eafcd-dfd9-fdae-c39f-ae07aa852ce18
1367410ergocalciferol 1.25 MG Oral CapsuleSCDf55eafcd-dfd9-fdae-c39f-ae07aa852ce18
1367410vit-D 1.25 MG Oral CapsuleSYf55eafcd-dfd9-fdae-c39f-ae07aa852ce18
1367410vitamin D 1.25 MG Oral CapsuleSYf55eafcd-dfd9-fdae-c39f-ae07aa852ce18
1367410vitamin D2 1250 MCG Oral CapsuleSYf55eafcd-dfd9-fdae-c39f-ae07aa852ce18
1367410vitamin D2 50,000 UNT Oral CapsuleSYf55eafcd-dfd9-fdae-c39f-ae07aa852ce18
1367410ergocalciferol 1.25 MG (50,000 UNT) Oral CapsulePSN2a8d73d6-9991-401b-ab8b-81f22e5a06957
1367410ergocalciferol 1.25 MG Oral CapsuleSCD2a8d73d6-9991-401b-ab8b-81f22e5a06957
1367410vit-D 1.25 MG Oral CapsuleSY2a8d73d6-9991-401b-ab8b-81f22e5a06957
1367410vitamin D 1.25 MG Oral CapsuleSY2a8d73d6-9991-401b-ab8b-81f22e5a06957
1367410vitamin D2 1250 MCG Oral CapsuleSY2a8d73d6-9991-401b-ab8b-81f22e5a06957
1367410vitamin D2 50,000 UNT Oral CapsuleSY2a8d73d6-9991-401b-ab8b-81f22e5a06957
1367410ergocalciferol 1.25 MG (50,000 UNT) Oral CapsulePSNc538ac91-2507-4f42-8f7a-013510539b306
1367410ergocalciferol 1.25 MG Oral CapsuleSCDc538ac91-2507-4f42-8f7a-013510539b306
1367410vit-D 1.25 MG Oral CapsuleSYc538ac91-2507-4f42-8f7a-013510539b306
1367410vitamin D 1.25 MG Oral CapsuleSYc538ac91-2507-4f42-8f7a-013510539b306
1367410vitamin D2 1250 MCG Oral CapsuleSYc538ac91-2507-4f42-8f7a-013510539b306
1367410vitamin D2 50,000 UNT Oral CapsuleSYc538ac91-2507-4f42-8f7a-013510539b306
1367410ergocalciferol 1.25 MG (50,000 UNT) Oral CapsulePSNc4793165-6647-4dba-b100-3986739cd01e5
1367410ergocalciferol 1.25 MG (50,000 UNT) Oral CapsulePSN5f4ef344-7880-3375-e053-2a91aa0a47b85
1367410ergocalciferol 1.25 MG Oral CapsuleSCD5f4ef344-7880-3375-e053-2a91aa0a47b85
1367410ergocalciferol 1.25 MG Oral CapsuleSCDc4793165-6647-4dba-b100-3986739cd01e5
1367410vit-D 1.25 MG Oral CapsuleSY5f4ef344-7880-3375-e053-2a91aa0a47b85
1367410vit-D 1.25 MG Oral CapsuleSYc4793165-6647-4dba-b100-3986739cd01e5
1367410vitamin D 1.25 MG Oral CapsuleSYc4793165-6647-4dba-b100-3986739cd01e5
1367410vitamin D 1.25 MG Oral CapsuleSY5f4ef344-7880-3375-e053-2a91aa0a47b85
1367410vitamin D2 1250 MCG Oral CapsuleSY5f4ef344-7880-3375-e053-2a91aa0a47b85
1367410vitamin D2 1250 MCG Oral CapsuleSYc4793165-6647-4dba-b100-3986739cd01e5
1367410vitamin D2 50,000 UNT Oral CapsuleSY5f4ef344-7880-3375-e053-2a91aa0a47b85
1367410vitamin D2 50,000 UNT Oral CapsuleSYc4793165-6647-4dba-b100-3986739cd01e5
1367410ergocalciferol 1.25 MG (50,000 UNT) Oral CapsulePSN84647b52-3c4c-31bb-e053-2991aa0a8a7e2
1367410ergocalciferol 1.25 MG Oral CapsuleSCD84647b52-3c4c-31bb-e053-2991aa0a8a7e2
1367410vit-D 1.25 MG Oral CapsuleSY84647b52-3c4c-31bb-e053-2991aa0a8a7e2
1367410vitamin D 1.25 MG Oral CapsuleSY84647b52-3c4c-31bb-e053-2991aa0a8a7e2
1367410vitamin D2 1250 MCG Oral CapsuleSY84647b52-3c4c-31bb-e053-2991aa0a8a7e2
1367410vitamin D2 50,000 UNT Oral CapsuleSY84647b52-3c4c-31bb-e053-2991aa0a8a7e2
1367410ergocalciferol 1.25 MG (50,000 UNT) Oral CapsulePSN1cd4afc6-ef90-4e7b-9f11-2bfbd137524c1
1367410ergocalciferol 1.25 MG Oral CapsuleSCD1cd4afc6-ef90-4e7b-9f11-2bfbd137524c1
1367410vit-D 1.25 MG Oral CapsuleSY1cd4afc6-ef90-4e7b-9f11-2bfbd137524c1
1367410vitamin D 1.25 MG Oral CapsuleSY1cd4afc6-ef90-4e7b-9f11-2bfbd137524c1
1367410vitamin D2 1250 MCG Oral CapsuleSY1cd4afc6-ef90-4e7b-9f11-2bfbd137524c1
1367410vitamin D2 50,000 UNT Oral CapsuleSY1cd4afc6-ef90-4e7b-9f11-2bfbd137524c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69452-151-2069452015120100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (69452-151-20) 2016-06-150000-00-00NoNoCurrent