Application 091004

Type: ANDA
Sponsor: SIGMAPHARM LABS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ERGOCALCIFEROL	ERGOCALCIFEROL	CAPSULE;ORAL	50,000 IU	No	No

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
A091004-001	ERGOCALCIFEROL	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL			2010-07-14

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091004-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2010-07-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091004-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2010-07-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091004-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2010-07-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091004-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2010-07-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091004-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2010-07-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091004-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2010-07-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091004-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2010-07-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091004-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2010-07-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091004-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2010-07-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091004-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2010-07-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091004-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2010-07-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091004-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2010-07-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091004-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2010-07-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091004-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2010-07-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091004-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2010-07-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091004-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2010-07-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091004-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2010-07-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091004-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2010-07-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091004-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2010-07-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091004-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2010-07-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091004-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2010-07-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091004-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2010-07-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091004-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2010-07-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091004-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2010-07-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091004-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2010-07-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091004-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2010-07-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091004-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2010-07-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091004-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2010-07-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091004-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2010-07-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091004-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2010-07-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091004-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2010-07-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091004-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2010-07-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091004-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2010-07-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091004-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2010-07-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091004-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2010-07-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091004-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2010-07-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091004-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2010-07-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091004-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2010-07-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091004-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2010-07-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091004-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2010-07-14	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A091004-001	AA	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091004-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091004-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091004-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091004-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091004-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091004-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091004-001	AA	1	`ea99ee380514…`

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 2 · 29 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VITAMIN D	ERGOCALCIFEROL	REMEDYREPACK INC.	3fe92511-0b4a-43f4-9c89-c8599469c1e2	2026-07-14	Warnings, Adverse reactions	Name fallback generic name: ERGOCALCIFEROL
ERGOCALCIFEROL	ERGOCALCIFEROL	Torrent Pharmaceuticals Limited	4ae38744-020d-4c37-a6f1-88f55c2f1047	2026-06-25	Warnings, Adverse reactions	Name fallback brand name: ERGOCALCIFEROL generic name: ERGOCALCIFEROL
Ergocalciferol	ERGOCALCIFEROL	REMEDYREPACK INC.	a80436e0-b507-4e7b-9a60-a9d5ddc4a045	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: Ergocalciferol generic name: ERGOCALCIFEROL
VITAMIN D	ERGOCALCIFEROL	Aphena Pharma Solutions - Tennessee, LLC	3c0f4142-cc1f-43de-8677-ee06b6f4fc10	2026-06-17	Warnings, Adverse reactions	Name fallback generic name: ERGOCALCIFEROL
Ergocalciferol	ERGOCALCIFEROL	Bryant Ranch Prepack	0d230fd8-2ea7-4dd6-a506-5f7804e539fc	2026-05-20	Warnings, Adverse reactions	Name fallback brand name: Ergocalciferol generic name: ERGOCALCIFEROL
Ergocalciferol	ERGOCALCIFEROL	Bryant Ranch Prepack	c4793165-6647-4dba-b100-3986739cd01e	2026-05-19	Warnings, Adverse reactions	Name fallback brand name: Ergocalciferol generic name: ERGOCALCIFEROL
Ergocalciferol	ERGOCALCIFEROL	Bryant Ranch Prepack	39b72d09-cedc-4130-89a3-1ea03f58ba04	2026-05-14	Warnings, Adverse reactions	Name fallback brand name: Ergocalciferol generic name: ERGOCALCIFEROL
Ergocalciferol	ERGOCALCIFEROL	St. Mary's Medical Park Pharmacy	5f4ef344-7880-3375-e053-2a91aa0a47b8	2026-05-05	Warnings, Adverse reactions	Name fallback brand name: Ergocalciferol generic name: ERGOCALCIFEROL
Ergocalciferol	ERGOCALCIFEROL	PD-Rx Pharmaceuticals, Inc.	2475e731-0072-4787-8a40-09137883c625	2026-05-05	Warnings, Adverse reactions	Name fallback brand name: Ergocalciferol generic name: ERGOCALCIFEROL
Ergocalciferol	ERGOCALCIFEROL	NuCare Pharmaceuticals, Inc.	492452d6-2b32-39c0-e054-00144ff8d46c	2026-04-30	Warnings, Adverse reactions	Name fallback brand name: Ergocalciferol generic name: ERGOCALCIFEROL
Ergocalciferol	ERGOCALCIFEROL	Preferred Pharmaceuticals Inc.	1cd4afc6-ef90-4e7b-9f11-2bfbd137524c	2026-03-17	Warnings, Adverse reactions	Name fallback brand name: Ergocalciferol generic name: ERGOCALCIFEROL
Ergocalciferol	ERGOCALCIFEROL CAPSULES,	A-S Medication Solutions	d9d45422-b7a2-4f8a-a00d-2754f8b26dd1	2026-01-13	Warnings, Adverse reactions	Name fallback brand name: Ergocalciferol
VITAMIN D	ERGOCALCIFEROL	AvPAK	a2b82923-f0dd-641f-e053-2995a90a7c4a	2026-01-08	Warnings, Adverse reactions	Name fallback generic name: ERGOCALCIFEROL
VITAMIN D	ERGOCALCIFEROL	Northwind Health Company, LLC	f3402462-5d86-b4c9-e053-2a95a90aaab0	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: ERGOCALCIFEROL
Ergocalciferol	ERGOCALCIFEROL	AvKARE	f55eafcd-dfd9-fdae-c39f-ae07aa852ce1	2025-12-03	Warnings, Adverse reactions	Name fallback brand name: Ergocalciferol generic name: ERGOCALCIFEROL
Ergocalciferol	ERGOCALCIFEROL	Bionpharma Inc.	2a8d73d6-9991-401b-ab8b-81f22e5a0695	2025-12-01	Warnings, Adverse reactions	Name fallback brand name: Ergocalciferol generic name: ERGOCALCIFEROL
VITAMIN D	ERGOCALCIFEROL	Preferred Pharmaceuticals, Inc.	ba2076ef-1650-45e1-b092-a4c449dd6210	2025-10-07	Warnings, Adverse reactions	Name fallback generic name: ERGOCALCIFEROL
VITAMIN D	ERGOCALCIFEROL	Golden State Medical Supply, Inc.	26aba724-8990-def9-e063-6394a90a991d	2025-04-15	Warnings, Adverse reactions	Name fallback generic name: ERGOCALCIFEROL
VITAMIN D	ERGOCALCIFEROL	PD-Rx Pharmaceuticals, Inc.	7e9b75e3-eb7c-4227-b953-166ac6897e54	2025-04-01	Warnings, Adverse reactions	Name fallback generic name: ERGOCALCIFEROL
Ergocalciferol	ERGOCALCIFEROL CAPSULES,	Bryant Ranch Prepack	2cdd7f42-bc90-4b41-9936-acc7d9b79088	2025-03-25	Warnings, Adverse reactions	Name fallback brand name: Ergocalciferol

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42794-006	Ergocalciferol	Ergocalciferol	SigmaPharm Laboratories, LLC	ANDA	Current
63187-064	Ergocalciferol	Ergocalciferol	Proficient Rx LP	ANDA	Current
63187-064	Ergocalciferol	Ergocalciferol	Proficient Rx LP	ANDA	Current
64205-157	Ergocalciferol	Ergocalciferol	ReadyMeds	ANDA	Current
64980-157	Ergocalciferol	Ergocalciferol	Rising Pharamceuticals, Inc	ANDA	Current
68151-0490	Ergocalciferol	Ergocalciferol	Carilion Materials Management	ANDA	Current