Ergocalciferol

Product NDC
62135-439
11-digit product format
621350439
Labeler code
62135
Product ID
62135-439_f409a4d6-5e02-18ee-e053-2a95a90a090c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ergocalciferol
Dosage form
CAPSULE
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA040833
Marketing category
ANDA
Marketing start
2018-04-30
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
A040833-001ERGOCALCIFEROLERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2009-05-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040833-001AA

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 UTC2026-02A040833-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2009-05-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040833-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2009-05-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A040833-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2009-05-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040833-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2009-05-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040833-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2009-05-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040833-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2009-05-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040833-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2009-05-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040833-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2009-05-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040833-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2009-05-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040833-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2009-05-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040833-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2009-05-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040833-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2009-05-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040833-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2009-05-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040833-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2009-05-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040833-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2009-05-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040833-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2009-05-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040833-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2009-05-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040833-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2009-05-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040833-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2009-05-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040833-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2009-05-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040833-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2009-05-2087673890dc5c…
2021-03-12 10:30 UTC2021-03A040833-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2009-05-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040833-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2009-05-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040833-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2009-05-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040833-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2009-05-203f01610625f2…
2019-09-15 20:21 UTC2019-09A040833-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2009-05-20b00525d2431f…
2019-07-19 19:46 UTC2019-07A040833-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2009-05-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040833-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2009-05-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040833-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2009-05-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040833-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2009-05-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040833-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2009-05-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040833-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2009-05-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040833-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2009-05-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040833-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2009-05-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A040833-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2009-05-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A040833-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2009-05-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040833-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2009-05-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040833-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2009-05-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040833-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2009-05-20e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040833-001ERGOCALCIFEROL50,000 IUCAPSULE / ORALAA2009-05-20cb3db0bc1861…

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 UTC2026-02A040833-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040833-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040833-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040833-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040833-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040833-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040833-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040833-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040833-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040833-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040833-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040833-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040833-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040833-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040833-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040833-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040833-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040833-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040833-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040833-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040833-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A040833-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040833-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040833-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040833-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A040833-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040833-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040833-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040833-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040833-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040833-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040833-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040833-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040833-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040833-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040833-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040833-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040833-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040833-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040833-001AA1cb3db0bc1861…

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
6490770b-82ef-4e7c-be93-999174d4ee59Available 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
62135-439-90Ergocalciferol90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-439-90EA - Each62135-4393cfcb804-8291-4837-abdc-84aac5fa9b5812023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-439ERGOCALCIFEROL CAPSULE [CHARTWELL RX, LLC]2Current NDC, Legacy NDC, 1 package rows20230207_6490770b-82ef-4e7c-be93-999174d4ee59.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ErgocalciferolERGOCALCIFEROLChartwell RX, LLC6490770b-82ef-4e7c-be93-999174d4ee592023-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040833
application number: ANDA040833
ndc (product): 62135-439

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1367410ergocalciferol 1.25 MG (50,000 UNT) Oral CapsulePSN6490770b-82ef-4e7c-be93-999174d4ee592
1367410ergocalciferol 1.25 MG Oral CapsuleSCD6490770b-82ef-4e7c-be93-999174d4ee592
1367410vit-D 1.25 MG Oral CapsuleSY6490770b-82ef-4e7c-be93-999174d4ee592
1367410vitamin D 1.25 MG Oral CapsuleSY6490770b-82ef-4e7c-be93-999174d4ee592
1367410vitamin D2 1250 MCG Oral CapsuleSY6490770b-82ef-4e7c-be93-999174d4ee592
1367410vitamin D2 50,000 UNT Oral CapsuleSY6490770b-82ef-4e7c-be93-999174d4ee592

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62135-439-906213504399090 CAPSULE in 1 BOTTLE (62135-439-90) 90 capsule2022-12-230000-00-00NoNoCurrent