Vitamin D

Product NDC
61919-702
11-digit product format
619190702
Labeler code
61919
Product ID
61919-702_30b47c4b-3c4d-d6fd-e063-6294a90a5664
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vitamin D
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
DirectRX
Application
ANDA080704
Marketing category
ANDA
Marketing start
2019-03-19
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-03-22 03:12 UTC · source 2025-03-21excluded productproduct61919-702IInactivated by FDAexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-70261919-702-04IInactivated by FDAexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproduct61919-702IInactivated by FDAexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-70261919-702-04IInactivated by FDAexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct61919-702UExcluded because listing certification expiredexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-70261919-702-04UExcluded because listing certification expiredexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproduct61919-702UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-70261919-702-04UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct61919-702UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-70261919-702-04UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A080704-001VITAMIN D50,000 IUCAPSULE / ORALAAApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A080704-001VITAMIN D50,000 IUCAPSULE / ORALAAApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A080704-001VITAMIN D50,000 IUCAPSULE / ORALAAApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080704-001VITAMIN D50,000 IUCAPSULE / ORALAAApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080704-001VITAMIN D50,000 IUCAPSULE / ORALAAApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080704-001VITAMIN D50,000 IUCAPSULE / ORALAAApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080704-001VITAMIN D50,000 IUCAPSULE / ORALAAApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A080704-001VITAMIN D50,000 IUCAPSULE / ORALAAApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A080704-001VITAMIN D50,000 IUCAPSULE / ORALAAApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A080704-001VITAMIN D50,000 IUCAPSULE / ORALAAApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A080704-001VITAMIN D50,000 IUCAPSULE / ORALAAApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A080704-001VITAMIN D50,000 IUCAPSULE / ORALAAApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A080704-001VITAMIN D50,000 IUCAPSULE / ORALAAApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A080704-001VITAMIN D50,000 IUCAPSULE / ORALAAApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A080704-001VITAMIN D50,000 IUCAPSULE / ORALAAApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A080704-001VITAMIN D50,000 IUCAPSULE / ORALAAApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A080704-001VITAMIN D50,000 IUCAPSULE / ORALAAApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A080704-001VITAMIN D50,000 IUCAPSULE / ORALAAApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A080704-001VITAMIN D50,000 IUCAPSULE / ORALAAApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A080704-001VITAMIN D50,000 IUCAPSULE / ORALAAApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A080704-001VITAMIN D50,000 IUCAPSULE / ORALAAApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A080704-001VITAMIN D50,000 IUCAPSULE / ORALAAApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A080704-001VITAMIN D50,000 IUCAPSULE / ORALAAApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A080704-001VITAMIN D50,000 IUCAPSULE / ORALAAApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A080704-001VITAMIN D50,000 IUCAPSULE / ORALAAApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A080704-001VITAMIN D50,000 IUCAPSULE / ORALAAApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A080704-001VITAMIN D50,000 IUCAPSULE / ORALAAApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A080704-001VITAMIN D50,000 IUCAPSULE / ORALAAApproved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A080704-001VITAMIN D50,000 IUCAPSULE / ORALAAApproved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A080704-001VITAMIN D50,000 IUCAPSULE / ORALAAApproved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A080704-001VITAMIN D50,000 IUCAPSULE / ORALAAApproved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A080704-001VITAMIN D50,000 IUCAPSULE / ORALAAApproved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A080704-001VITAMIN D50,000 IUCAPSULE / ORALAAApproved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A080704-001VITAMIN D50,000 IUCAPSULE / ORALAAApproved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05A080704-001VITAMIN D50,000 IUCAPSULE / ORALAAApproved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A080704-001VITAMIN D50,000 IUCAPSULE / ORALAAApproved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A080704-001VITAMIN D50,000 IUCAPSULE / ORALAAApproved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A080704-001VITAMIN D50,000 IUCAPSULE / ORALAAApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A080704-001VITAMIN D50,000 IUCAPSULE / ORALAAApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A080704-001VITAMIN D50,000 IUCAPSULE / ORALAAApproved before 1982cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A080704-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A080704-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A080704-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080704-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080704-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080704-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080704-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A080704-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A080704-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A080704-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A080704-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A080704-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A080704-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A080704-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A080704-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A080704-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A080704-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A080704-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A080704-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A080704-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A080704-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A080704-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A080704-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A080704-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A080704-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A080704-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A080704-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A080704-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A080704-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A080704-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A080704-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A080704-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A080704-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A080704-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A080704-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A080704-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A080704-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A080704-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A080704-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A080704-001AA1cb3db0bc1861…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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
Vitamin DVITAMIN DDirectRX84647b52-3c4c-31bb-e053-2991aa0a8a7e2025-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080704
application number: ANDA080704
ndc (product): 61919-702
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
Vitamin D
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
84647b52-3c4c-31bb-e053-2991aa0a8a7eAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-702-042025-03-19C16284748780-12cef2736-715b-d83d-e063-dadaa90ab31fVITAMIN D
61919-702-042025-01-30C16284748780-12cef2736-715b-d83d-e063-dadaa90ab31fVITAMIN D

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-702-04Vitamin D4 in 1 BOTTLECAPSULE, LIQUID FILLED42
61919-702-08Vitamin D8 in 1 BOTTLECAPSULE, LIQUID FILLED82

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-702-04EA - Each61919-70228075da2-367e-4c01-936a-270a4fd6b45a12019-08-06
61919-702-08EA - Each61919-702dfcfc13f-8956-4b86-8db8-097c5a9fc33912025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-702VITAMIN D CAPSULE, LIQUID FILLED [DIRECTRX]2Current NDC, Legacy NDC, 2 package rows20250322_84647b52-3c4c-31bb-e053-2991aa0a8a7e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-702-04619190702044 CAPSULE, LIQUID FILLED in 1 BOTTLE (61919-702-04) 2019-03-190000-00-00NoNoCurrent
61919-702-08619190702088 CAPSULE, LIQUID FILLED in 1 BOTTLE (61919-702-08) 2019-03-19NoNoCurrent