Ergocalciferol

Product NDC: 50090-4382
Requested package NDC: 50090-4382-2
11-digit product format: 500904382
Labeler code: 50090
Product ID: 50090-4382_4e20091d-dda3-41c2-a206-1a3417d16647
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ergocalciferol
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA080704
Marketing category: ANDA
Marketing start: 2016-06-15
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: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-4382	50090-4382-2	D	Discontinued by firm		2026-08-03

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 · 11 matching rows.

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

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

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A080704-001	VITAMIN D	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A080704-001	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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080704-001	VITAMIN D	50,000 IU	CAPSULE / ORAL	AA	Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A080704-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080704-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080704-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080704-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080704-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080704-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080704-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080704-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080704-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080704-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080704-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080704-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080704-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080704-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080704-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080704-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080704-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080704-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080704-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080704-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080704-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080704-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080704-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080704-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080704-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080704-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080704-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080704-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080704-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080704-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080704-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080704-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080704-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080704-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080704-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080704-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080704-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080704-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A080704-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080704-001	AA	1	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50090-4382-0	2023-02-06	Vitamin D (Ergocalciferol Capsules, USP)
50090-4382-1	2023-02-06	Vitamin D (Ergocalciferol Capsules, USP)
50090-4382-2	2023-02-06	Vitamin D (Ergocalciferol Capsules, USP)
50090-4382-3	2023-02-06	Vitamin D (Ergocalciferol Capsules, USP)
50090-4382-0	2023-01-30	Vitamin D (Ergocalciferol Capsules, USP)
50090-4382-1	2023-01-30	Vitamin D (Ergocalciferol Capsules, USP)
50090-4382-2	2023-01-30	Vitamin D (Ergocalciferol Capsules, USP)
50090-4382-3	2023-01-30	Vitamin D (Ergocalciferol Capsules, USP)

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-4382-1	EA - Each	50090-4382	d1a0021c-5d56-4e4b-bcc2-5d2196e5d552	1	2022-07-06
50090-4382-2	EA - Each	50090-4382	d0a79255-9d54-4db0-a565-eda80e9b2f69	1	2022-07-06
50090-4382-3	EA - Each	50090-4382	6b14152b-1835-4c8b-b681-7c9a0aae118d	1	2022-07-06

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ergocalciferol	ERGOCALCIFEROL	REMEDYREPACK INC.	a80436e0-b507-4e7b-9a60-a9d5ddc4a045	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080704 application number: ANDA080704
Ergocalciferol	ERGOCALCIFEROL	Bryant Ranch Prepack	0d230fd8-2ea7-4dd6-a506-5f7804e539fc	2026-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080704 application number: ANDA080704
Ergocalciferol	ERGOCALCIFEROL	Bryant Ranch Prepack	c4793165-6647-4dba-b100-3986739cd01e	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080704 application number: ANDA080704
Ergocalciferol	ERGOCALCIFEROL	Bryant Ranch Prepack	39b72d09-cedc-4130-89a3-1ea03f58ba04	2026-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080704 application number: ANDA080704
Ergocalciferol	ERGOCALCIFEROL	St. Mary's Medical Park Pharmacy	5f4ef344-7880-3375-e053-2a91aa0a47b8	2026-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080704 application number: ANDA080704
Ergocalciferol	ERGOCALCIFEROL	PD-Rx Pharmaceuticals, Inc.	2475e731-0072-4787-8a40-09137883c625	2026-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080704 application number: ANDA080704
Ergocalciferol	ERGOCALCIFEROL	NuCare Pharmaceuticals, Inc.	492452d6-2b32-39c0-e054-00144ff8d46c	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080704 application number: ANDA080704
Ergocalciferol	ERGOCALCIFEROL	Preferred Pharmaceuticals Inc.	1cd4afc6-ef90-4e7b-9f11-2bfbd137524c	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080704 application number: ANDA080704
Ergocalciferol	ERGOCALCIFEROL	AvKARE	f55eafcd-dfd9-fdae-c39f-ae07aa852ce1	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080704 application number: ANDA080704
Ergocalciferol	ERGOCALCIFEROL	Bionpharma Inc.	2a8d73d6-9991-401b-ab8b-81f22e5a0695	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080704 application number: ANDA080704
Vitamin D	VITAMIN D	DirectRX	84647b52-3c4c-31bb-e053-2991aa0a8a7e	2025-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080704 application number: ANDA080704
Ergocalciferol	ERGOCALCIFEROL	Aphena Pharma Solutions - Tennessee, LLC	c538ac91-2507-4f42-8f7a-013510539b30	2024-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080704 application number: ANDA080704
Ergocalciferol	ERGOCALCIFEROL	Bryant Ranch Prepack	9e63d720-cce8-4a59-b311-26cfca113957	2024-04-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080704 application number: ANDA080704
Ergocalciferol	ERGOCALCIFEROL	Aphena Pharma Solutions - Tennessee, LLC	2841b0ba-3b09-4f03-a060-9fb7f1af8344	2018-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080704 application number: ANDA080704

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-4382-2	50090438202	4 CAPSULE, LIQUID FILLED in 1 BOTTLE (50090-4382-2)	2019-06-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Vitamin D (Ergocalciferol Capsules, USP)	A-S Medication Solutions	2023-02-06	HUMAN PRESCRIPTION DRUG LABEL	8