Application 040865

Type: ANDA
Sponsor: SUN PHARM INDS INC

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 43.

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
A040865-001	ERGOCALCIFEROL	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL			2009-12-29

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 · 43 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
2026-09-14 22:38:34	2026-08	A040865-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2009-12-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040865-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2009-12-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040865-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2009-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040865-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2009-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040865-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2009-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040865-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2009-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040865-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2009-12-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040865-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2009-12-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040865-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2009-12-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040865-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2009-12-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040865-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2009-12-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040865-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2009-12-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040865-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2009-12-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040865-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2009-12-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040865-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2009-12-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040865-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2009-12-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040865-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-12-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040865-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-12-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040865-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-12-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040865-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-12-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040865-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-12-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040865-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-12-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040865-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-12-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040865-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-12-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040865-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-12-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040865-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-12-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040865-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-12-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040865-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-12-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040865-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-12-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040865-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2009-12-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040865-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL		2009-12-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040865-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-12-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040865-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-12-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040865-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-12-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040865-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-12-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040865-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-12-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040865-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-12-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040865-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-12-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040865-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-12-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040865-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2009-12-29	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040865-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040865-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040865-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040865-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040865-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040865-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040865-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040865-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040865-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040865-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040865-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040865-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040865-001	AA	1	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	A040865-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040865-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040865-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040865-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040865-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040865-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040865-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040865-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040865-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040865-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040865-001	AA	1	`cb3db0bc1861…`

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 2 of 2 · 29 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VITAMIN D	ERGOCALCIFEROL	Strides Pharma Science Limited	2c4c0a36-12cf-444d-9d57-de983eef4d36	2025-03-10	Warnings, Adverse reactions	Name fallback generic name: ERGOCALCIFEROL
VITAMIN D	ERGOCALCIFEROL	Bryant Ranch Prepack	a8aa37f4-7e94-4425-beea-49c938294a23	2024-10-02	Warnings, Adverse reactions	Name fallback generic name: ERGOCALCIFEROL
Ergocalciferol	ERGOCALCIFEROL CAPSULES,	Bryant Ranch Prepack	5dc330a2-a12d-4fd3-8d91-a8d9f31b2eae	2024-08-28	Warnings, Adverse reactions	Name fallback brand name: Ergocalciferol
Ergocalciferol	ERGOCALCIFEROL	NuCare Pharmaceuticals,Inc.	b43d7134-6c68-556b-e053-2995a90a38ef	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: Ergocalciferol generic name: ERGOCALCIFEROL
Ergocalciferol	ERGOCALCIFEROL	Aphena Pharma Solutions - Tennessee, LLC	c538ac91-2507-4f42-8f7a-013510539b30	2024-05-13	Warnings, Adverse reactions	Name fallback brand name: Ergocalciferol generic name: ERGOCALCIFEROL
Ergocalciferol	ERGOCALCIFEROL	Bryant Ranch Prepack	9e63d720-cce8-4a59-b311-26cfca113957	2024-04-05	Warnings, Adverse reactions	Name fallback brand name: Ergocalciferol generic name: ERGOCALCIFEROL
Ergocalciferol	ERGOCALCIFEROL	Chartwell RX, LLC	6490770b-82ef-4e7c-be93-999174d4ee59	2023-02-06	Warnings, Adverse reactions	Name fallback brand name: Ergocalciferol generic name: ERGOCALCIFEROL
VITAMIN D	ERGOCALCIFEROL	Proficient Rx LP	548365c1-b51c-4a8b-ae3d-50b41aba12db	2022-04-01	Warnings, Adverse reactions	Name fallback generic name: ERGOCALCIFEROL
Ergocalciferol	ERGOCALCIFEROL	Aphena Pharma Solutions - Tennessee, LLC	2841b0ba-3b09-4f03-a060-9fb7f1af8344	2018-12-18	Warnings, Adverse reactions	Name fallback brand name: Ergocalciferol generic name: ERGOCALCIFEROL

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43353-828	VITAMIN D	ergocalciferol	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
63629-6321	VITAMIN D	ergocalciferol	Bryant Ranch Prepack	ANDA	Current
68788-6372	VITAMIN D	ergocalciferol	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9256	VITAMIN D	ergocalciferol	Preferred Pharmaceuticals, Inc.	ANDA	Current