Ergocalciferol

Product NDC
71335-1691
11-digit product format
713351691
Labeler code
71335
Product ID
71335-1691_5af407a7-839c-4d9a-8ad0-59df489e9ae9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ergocalciferol Capsules,
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204276
Marketing category
ANDA
Marketing start
2018-12-10
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
A204276-001ERGOCALCIFEROLERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2018-12-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204276-001AA

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 UTC2026-02A204276-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2018-12-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204276-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2018-12-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A204276-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2018-12-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204276-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2018-12-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204276-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2018-12-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204276-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2018-12-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204276-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2018-12-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204276-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2018-12-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204276-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2018-12-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204276-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2018-12-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204276-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2018-12-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204276-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2018-12-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204276-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2018-12-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204276-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2018-12-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204276-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2018-12-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204276-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2018-12-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204276-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2018-12-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204276-001ERGOCALCIFEROL50000IUCAPSULE / ORALAA2018-12-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204276-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2018-12-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204276-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2018-12-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204276-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2018-12-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A204276-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2018-12-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204276-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2018-12-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204276-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2018-12-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204276-001ERGOCALCIFEROL50000IUCAPSULE / ORALAA2018-12-073f01610625f2…
2019-09-15 20:21 UTC2019-09A204276-001ERGOCALCIFEROL50000IUCAPSULE / ORALAA2018-12-07b00525d2431f…
2019-07-19 19:46 UTC2019-07A204276-001ERGOCALCIFEROL50000IUCAPSULE / ORALAA2018-12-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204276-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2018-12-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204276-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2018-12-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A204276-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2018-12-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204276-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2018-12-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204276-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2018-12-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204276-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2018-12-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204276-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2018-12-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A204276-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2018-12-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A204276-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2018-12-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204276-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2018-12-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A204276-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2018-12-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A204276-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2018-12-07e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A204276-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2018-12-07cb3db0bc1861…

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 UTC2026-02A204276-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204276-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204276-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204276-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204276-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204276-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204276-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204276-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204276-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204276-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204276-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204276-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204276-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204276-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204276-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204276-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204276-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204276-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204276-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204276-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204276-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A204276-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204276-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204276-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204276-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A204276-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A204276-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204276-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204276-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A204276-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204276-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204276-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204276-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204276-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A204276-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A204276-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204276-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A204276-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A204276-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A204276-001AA1cb3db0bc1861…

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
5dc330a2-a12d-4fd3-8d91-a8d9f31b2eaeAvailable 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
71335-1691-0Ergocalciferol45 in 1 BOTTLECAPSULE455
71335-1691-1Ergocalciferol12 in 1 BOTTLECAPSULE125
71335-1691-2Ergocalciferol30 in 1 BOTTLECAPSULE305
71335-1691-3Ergocalciferol100 in 1 BOTTLECAPSULE1005
71335-1691-4Ergocalciferol4 in 1 BOTTLECAPSULE45
71335-1691-5Ergocalciferol20 in 1 BOTTLECAPSULE205
71335-1691-6Ergocalciferol8 in 1 BOTTLECAPSULE85
71335-1691-7Ergocalciferol15 in 1 BOTTLECAPSULE155
71335-1691-8Ergocalciferol120 in 1 BOTTLECAPSULE1205
71335-1691-9Ergocalciferol60 in 1 BOTTLECAPSULE605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1691-6EA - Each71335-16914b945513-6400-4587-87d0-b3378e2b6c5812025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1691ERGOCALCIFEROL (ERGOCALCIFEROL CAPSULES,) CAPSULE [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 10 package rows20240830_5dc330a2-a12d-4fd3-8d91-a8d9f31b2eae.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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ergocalciferol Capsules,ERGOCALCIFEROL CAPSULES,Aphena Pharma Solutions - Tennessee, LLC56454180-0ae8-a267-e063-6394a90a491c2026-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204276
application number: ANDA204276
Ergocalciferol Capsules,ERGOCALCIFEROL CAPSULES,Proficient Rx LPc22a625f-f526-477a-85e5-23abe57712842026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204276
application number: ANDA204276
Ergocalciferol Capsules,ERGOCALCIFEROL CAPSULES,REMEDYREPACK INC.75fa8580-3322-473d-b836-4929f8c401652026-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204276
application number: ANDA204276
ErgocalciferolERGOCALCIFEROL CAPSULES,A-S Medication Solutionsd9d45422-b7a2-4f8a-a00d-2754f8b26dd12026-01-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204276
application number: ANDA204276
Ergocalciferol Capsules,ERGOCALCIFEROL CAPSULES,Northwind Health Company, LLCdb98e670-02ef-208a-e053-2995a90aca922026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204276
application number: ANDA204276
Ergocalciferol Capsules,ERGOCALCIFEROL CAPSULES,Preferred Pharmaceuticals Inc.eefdca6e-e5b7-4323-aa92-e0bb8275947d2025-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204276
application number: ANDA204276
Ergocalciferol Capsules,ERGOCALCIFEROL CAPSULES,Bryant Ranch Prepackaf8a25f4-7a4d-47ed-827f-308f687d9eae2025-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204276
application number: ANDA204276
ErgocalciferolERGOCALCIFEROL CAPSULES,Bryant Ranch Prepack2cdd7f42-bc90-4b41-9936-acc7d9b790882025-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204276
application number: ANDA204276
Ergocalciferol Capsules,ERGOCALCIFEROL CAPSULES,Epic Pharma LLCe58cfb46-f8a7-4327-bbe8-da4d4be2bd1d2025-01-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204276
application number: ANDA204276
Ergocalciferol (Vitamin D2)ERGOCALCIFEROL (VITAMIN D2)Advanced Rx Pharmacy of Tennessee, LLCbc3ed1e0-0bb9-1cc0-e053-2995a90a48fe2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204276
application number: ANDA204276
ErgocalciferolERGOCALCIFEROL CAPSULES,Bryant Ranch Prepack5dc330a2-a12d-4fd3-8d91-a8d9f31b2eae2024-08-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204276
application number: ANDA204276
ndc (product): 71335-1691
ErgocalciferolERGOCALCIFEROLNuCare Pharmaceuticals,Inc.b43d7134-6c68-556b-e053-2995a90a38ef2024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204276
application number: ANDA204276

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1367410ergocalciferol 1.25 MG (50,000 UNT) Oral CapsulePSN5dc330a2-a12d-4fd3-8d91-a8d9f31b2eae5
1367410ergocalciferol 1.25 MG Oral CapsuleSCD5dc330a2-a12d-4fd3-8d91-a8d9f31b2eae5
1367410vit-D 1.25 MG Oral CapsuleSY5dc330a2-a12d-4fd3-8d91-a8d9f31b2eae5
1367410vitamin D 1.25 MG Oral CapsuleSY5dc330a2-a12d-4fd3-8d91-a8d9f31b2eae5
1367410vitamin D2 1250 MCG Oral CapsuleSY5dc330a2-a12d-4fd3-8d91-a8d9f31b2eae5
1367410vitamin D2 50,000 UNT Oral CapsuleSY5dc330a2-a12d-4fd3-8d91-a8d9f31b2eae5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1691-07133516910045 CAPSULE in 1 BOTTLE (71335-1691-0) 45 capsule2020-08-200000-00-00NoNoCurrent
71335-1691-17133516910112 CAPSULE in 1 BOTTLE (71335-1691-1) 12 capsule2020-08-200000-00-00NoNoCurrent
71335-1691-27133516910230 CAPSULE in 1 BOTTLE (71335-1691-2) 30 capsule2020-08-200000-00-00NoNoCurrent
71335-1691-371335169103100 CAPSULE in 1 BOTTLE (71335-1691-3) 100 capsule2020-08-200000-00-00NoNoCurrent
71335-1691-4713351691044 CAPSULE in 1 BOTTLE (71335-1691-4) 4 capsule2020-08-200000-00-00NoNoCurrent
71335-1691-57133516910520 CAPSULE in 1 BOTTLE (71335-1691-5) 20 capsule2020-08-200000-00-00NoNoCurrent
71335-1691-6713351691068 CAPSULE in 1 BOTTLE (71335-1691-6) 8 capsule2020-08-200000-00-00NoNoCurrent
71335-1691-77133516910715 CAPSULE in 1 BOTTLE (71335-1691-7) 15 capsule2020-08-200000-00-00NoNoCurrent
71335-1691-871335169108120 CAPSULE in 1 BOTTLE (71335-1691-8) 120 capsule2020-08-200000-00-00NoNoCurrent
71335-1691-97133516910960 CAPSULE in 1 BOTTLE (71335-1691-9) 60 capsule2020-08-200000-00-00NoNoCurrent