VITAMIN D

Product NDC
63187-519
11-digit product format
631870519
Labeler code
63187
Product ID
63187-519_a7b1d449-215a-4356-b1f9-bc04f39c9b60
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ergocalciferol
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
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

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
A090455-001ERGOCALCIFEROLERGOCALCIFEROL50,000 IUCAPSULE / ORALAARS2010-08-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090455-001AA

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 UTC2026-02A090455-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAARS2010-08-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090455-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAARS2010-08-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A090455-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAARS2010-08-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090455-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAARS2010-08-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090455-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAARS2010-08-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090455-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAARS2010-08-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090455-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAARS2010-08-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090455-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAARS2010-08-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090455-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAARS2010-08-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090455-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAARS2010-08-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090455-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAARS2010-08-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090455-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAARS2010-08-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090455-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAARS2010-08-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090455-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAARS2010-08-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090455-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2010-08-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090455-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2010-08-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090455-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2010-08-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090455-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2010-08-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090455-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2010-08-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090455-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2010-08-03782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090455-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2010-08-0387673890dc5c…
2021-03-12 10:30 UTC2021-03A090455-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2010-08-035aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090455-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2010-08-038869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090455-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2010-08-03c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090455-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2010-08-033f01610625f2…
2019-09-15 20:21 UTC2019-09A090455-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2010-08-03b00525d2431f…
2019-07-19 19:46 UTC2019-07A090455-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2010-08-03ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090455-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAARS2010-08-036a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090455-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAARS2010-08-031c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090455-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAARS2010-08-03ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090455-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAARS2010-08-03a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090455-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAARS2010-08-039b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090455-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAARS2010-08-03a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090455-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAARS2010-08-033f0d92c62455…
2023-05-13 08:27 UTC2023-05A090455-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAARS2010-08-03053a50430f4f…
2023-01-26 05:58 UTC2023-01A090455-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2010-08-033bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090455-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2010-08-033a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090455-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2010-08-03f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090455-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2010-08-03e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090455-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2010-08-03cb3db0bc1861…

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 UTC2026-02A090455-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090455-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090455-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090455-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090455-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090455-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090455-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090455-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090455-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090455-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090455-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090455-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090455-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090455-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090455-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090455-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090455-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090455-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090455-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090455-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090455-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A090455-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090455-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090455-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090455-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A090455-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090455-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090455-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090455-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090455-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090455-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090455-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090455-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090455-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090455-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090455-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090455-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090455-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090455-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090455-001AA1cb3db0bc1861…

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
548365c1-b51c-4a8b-ae3d-50b41aba12dbAvailable 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
63187-519-06VITAMIN D6 in 1 BOTTLE, PLASTICCAPSULE68
63187-519-08VITAMIN D8 in 1 BOTTLE, PLASTICCAPSULE88
63187-519-12VITAMIN D12 in 1 BOTTLE, PLASTICCAPSULE128
63187-519-16VITAMIN D16 in 1 BOTTLE, PLASTICCAPSULE168
63187-519-30VITAMIN D30 in 1 BOTTLE, PLASTICCAPSULE308
63187-519-60VITAMIN D60 in 1 BOTTLE, PLASTICCAPSULE608
63187-519-90VITAMIN D90 in 1 BOTTLE, PLASTICCAPSULE908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-519-06EA - Each63187-519d5048f17-bac7-445f-93f1-e20f29b9be5312017-12-14

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-519VITAMIN D (ERGOCALCIFEROL) CAPSULE [PROFICIENT RX LP]8Current NDC, Legacy NDC, 7 package rows20220421_548365c1-b51c-4a8b-ae3d-50b41aba12db.zip

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VITAMIN DERGOCALCIFEROLREMEDYREPACK INC.3fe92511-0b4a-43f4-9c89-c8599469c1e22026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090455
application number: ANDA090455
VITAMIN DERGOCALCIFEROLAphena Pharma Solutions - Tennessee, LLC3c0f4142-cc1f-43de-8677-ee06b6f4fc102026-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090455
application number: ANDA090455
VITAMIN DERGOCALCIFEROLAvPAKa2b82923-f0dd-641f-e053-2995a90a7c4a2026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090455
application number: ANDA090455
VITAMIN DERGOCALCIFEROLNorthwind Health Company, LLCf3402462-5d86-b4c9-e053-2a95a90aaab02026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090455
application number: ANDA090455
VITAMIN DERGOCALCIFEROLPreferred Pharmaceuticals, Inc.ba2076ef-1650-45e1-b092-a4c449dd62102025-10-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090455
application number: ANDA090455
VITAMIN DERGOCALCIFEROLGolden State Medical Supply, Inc.26aba724-8990-def9-e063-6394a90a991d2025-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090455
application number: ANDA090455
VITAMIN DERGOCALCIFEROLPD-Rx Pharmaceuticals, Inc.7e9b75e3-eb7c-4227-b953-166ac6897e542025-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090455
application number: ANDA090455
VITAMIN DERGOCALCIFEROLStrides Pharma Science Limited2c4c0a36-12cf-444d-9d57-de983eef4d362025-03-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090455
application number: ANDA090455
VITAMIN DERGOCALCIFEROLBryant Ranch Prepacka8aa37f4-7e94-4425-beea-49c938294a232024-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090455
application number: ANDA090455
VITAMIN DERGOCALCIFEROLProficient Rx LP548365c1-b51c-4a8b-ae3d-50b41aba12db2022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090455
application number: ANDA090455
ndc (product): 63187-519

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1367410ergocalciferol 1.25 MG (50,000 UNT) Oral CapsulePSN548365c1-b51c-4a8b-ae3d-50b41aba12db8
1367410ergocalciferol 1.25 MG Oral CapsuleSCD548365c1-b51c-4a8b-ae3d-50b41aba12db8
1367410vit-D 1.25 MG Oral CapsuleSY548365c1-b51c-4a8b-ae3d-50b41aba12db8
1367410vitamin D 1.25 MG Oral CapsuleSY548365c1-b51c-4a8b-ae3d-50b41aba12db8
1367410vitamin D2 1250 MCG Oral CapsuleSY548365c1-b51c-4a8b-ae3d-50b41aba12db8
1367410vitamin D2 50,000 UNT Oral CapsuleSY548365c1-b51c-4a8b-ae3d-50b41aba12db8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-519-06631870519066 CAPSULE in 1 BOTTLE, PLASTIC (63187-519-06) 6 capsule2017-10-020000-00-00NoNoCurrent
63187-519-08631870519088 CAPSULE in 1 BOTTLE, PLASTIC (63187-519-08) 8 capsule2016-01-010000-00-00NoNoCurrent
63187-519-126318705191212 CAPSULE in 1 BOTTLE, PLASTIC (63187-519-12) 12 capsule2020-10-280000-00-00NoNoCurrent
63187-519-166318705191616 CAPSULE in 1 BOTTLE, PLASTIC (63187-519-16) 16 capsule2016-02-010000-00-00NoNoCurrent
63187-519-306318705193030 CAPSULE in 1 BOTTLE, PLASTIC (63187-519-30) 30 capsule2015-08-030000-00-00NoNoCurrent
63187-519-606318705196060 CAPSULE in 1 BOTTLE, PLASTIC (63187-519-60) 60 capsule2015-08-030000-00-00NoNoCurrent
63187-519-906318705199090 CAPSULE in 1 BOTTLE, PLASTIC (63187-519-90) 90 capsule2015-08-030000-00-00NoNoCurrent