Ergocalciferol

Product NDC: 60760-749
11-digit product format: 607600749
Labeler code: 60760
Product ID: 60760-749_7b306ae0-d0ea-b262-e053-2a91aa0a8b04
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ergocalciferol
Dosage form: CAPSULE
Route: ORAL
Labeler: St Marys Medical Park Pharmacy
Application: ANDA040833
Marketing category: ANDA
Marketing start: 2014-05-22
Marketing end: 0000-00-00
Substance: ERGOCALCIFEROL
Active strength: 1 mg/1
Pharmacologic classes: Ergocalciferols [CS],Provitamin D2 Compound [EPC]
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	60760-749		D	Discontinued by firm	2026-10-15
excluded package	package	60760-749	60760-749-04	D	Discontinued by firm	2026-10-15
excluded package	package	60760-749	60760-749-12	D	Discontinued by firm	2026-10-15

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	60760-749-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	60760-749-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	60760-749-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	60760-749-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	60760-749-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	60760-749-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	60760-749-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	60760-749-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	60760-749-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	60760-749-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	60760-749-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	60760-749-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	60760-749-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	60760-749-12	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	60760-749-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	60760-749-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	60760-749-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	60760-749-12	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	60760-749-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	60760-749-12	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	60760-749-04	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	60760-749-12	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	60760-749-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	60760-749-12	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040833-001	ERGOCALCIFEROL	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA		2009-05-20

Therapeutic equivalence codes#

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

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

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040833-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-05-20	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A040833-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040833-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040833-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A040833-001	AA	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60760-749-04	EA - Each	60760-749	1efd990e-8a21-4e1e-aa26-32a608b7456a	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Ergocalciferol	ACTIVE INGREDIENT	VS041H42XC	ERGOCALCIFEROL CAPSULE [ST MARYS MEDICAL PARK PHARMACY]	3
Ergocalciferol	ACTIVE MOIETY	VS041H42XC	ERGOCALCIFEROL CAPSULE [ST MARYS MEDICAL PARK PHARMACY]	3
D&C Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	ERGOCALCIFEROL CAPSULE [ST MARYS MEDICAL PARK PHARMACY]	3
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	ERGOCALCIFEROL CAPSULE [ST MARYS MEDICAL PARK PHARMACY]	3
Gelatin	INACTIVE INGREDIENT	2G86QN327L	ERGOCALCIFEROL CAPSULE [ST MARYS MEDICAL PARK PHARMACY]	3
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	ERGOCALCIFEROL CAPSULE [ST MARYS MEDICAL PARK PHARMACY]	3
Soybean Oil	INACTIVE INGREDIENT	241ATL177A	ERGOCALCIFEROL CAPSULE [ST MARYS MEDICAL PARK PHARMACY]	3
Water	INACTIVE INGREDIENT	059QF0KO0R	ERGOCALCIFEROL CAPSULE [ST MARYS MEDICAL PARK PHARMACY]	3

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ergocalciferol	ERGOCALCIFEROL	Chartwell RX, LLC	6490770b-82ef-4e7c-be93-999174d4ee59	2023-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040833 application number: ANDA040833

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
VS041H42XC	ERGOCALCIFEROL	50-14-6	ERGOCALCIFEROL

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
VITAMIN D, ERGOCALCIFEROL Capsules, USP, 1.25 mg SOFTGEL CAPSULES (Soft Gelatin Capsules) (50,000 USP Units)	St Marys Medical Park Pharmacy \| Swiss Caps AG	2018-11-21	HUMAN PRESCRIPTION DRUG LABEL	6