Application 204276

Type: ANDA
Sponsor: PURACAP PHARM 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
A204276-001	ERGOCALCIFEROL	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA		2018-12-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204276-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204276-001	ERGOCALCIFEROL	50000IU	CAPSULE / ORAL	AA	2018-12-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204276-001	ERGOCALCIFEROL	50000IU	CAPSULE / ORAL	AA	2018-12-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204276-001	ERGOCALCIFEROL	50000IU	CAPSULE / ORAL	AA	2018-12-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204276-001	ERGOCALCIFEROL	50000IU	CAPSULE / ORAL	AA	2018-12-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204276-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	2018-12-07	`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	A204276-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204276-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204276-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204276-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204276-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204276-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204276-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204276-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204276-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204276-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204276-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204276-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204276-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204276-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204276-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204276-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204276-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204276-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204276-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204276-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204276-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204276-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204276-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204276-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204276-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204276-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204276-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204276-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204276-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204276-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204276-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204276-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204276-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204276-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204276-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204276-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204276-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204276-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204276-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204276-001	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 1 of 1 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ergocalciferol Capsules,	ERGOCALCIFEROL CAPSULES,	Aphena Pharma Solutions - Tennessee, LLC	56454180-0ae8-a267-e063-6394a90a491c	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204276 application number: ANDA204276
Ergocalciferol Capsules,	ERGOCALCIFEROL CAPSULES,	Proficient Rx LP	c22a625f-f526-477a-85e5-23abe5771284	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204276 application number: ANDA204276 ndc (product): 71205-676
Ergocalciferol Capsules,	ERGOCALCIFEROL CAPSULES,	REMEDYREPACK INC.	75fa8580-3322-473d-b836-4929f8c40165	2026-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204276 application number: ANDA204276 ndc (product): 70518-3472
Ergocalciferol	ERGOCALCIFEROL CAPSULES,	A-S Medication Solutions	d9d45422-b7a2-4f8a-a00d-2754f8b26dd1	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204276 application number: ANDA204276 ndc (product): 50090-5844
Ergocalciferol Capsules,	ERGOCALCIFEROL CAPSULES,	Northwind Health Company, LLC	db98e670-02ef-208a-e053-2995a90aca92	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204276 application number: ANDA204276
Ergocalciferol Capsules,	ERGOCALCIFEROL CAPSULES,	Preferred Pharmaceuticals Inc.	eefdca6e-e5b7-4323-aa92-e0bb8275947d	2025-10-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204276 application number: ANDA204276
Ergocalciferol Capsules,	ERGOCALCIFEROL CAPSULES,	Bryant Ranch Prepack	af8a25f4-7a4d-47ed-827f-308f687d9eae	2025-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204276 application number: ANDA204276 ndc (product): 71335-2003
Ergocalciferol	ERGOCALCIFEROL CAPSULES,	Bryant Ranch Prepack	2cdd7f42-bc90-4b41-9936-acc7d9b79088	2025-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204276 application number: ANDA204276 ndc (product): 63629-7913
Ergocalciferol Capsules,	ERGOCALCIFEROL CAPSULES,	Epic Pharma LLC	e58cfb46-f8a7-4327-bbe8-da4d4be2bd1d	2025-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204276 application number: ANDA204276 ndc (product): 42806-547
Ergocalciferol (Vitamin D2)	ERGOCALCIFEROL (VITAMIN D2)	Advanced Rx Pharmacy of Tennessee, LLC	bc3ed1e0-0bb9-1cc0-e053-2995a90a48fe	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204276 application number: ANDA204276 ndc (product): 80425-0130
Ergocalciferol	ERGOCALCIFEROL CAPSULES,	Bryant Ranch Prepack	5dc330a2-a12d-4fd3-8d91-a8d9f31b2eae	2024-08-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204276 application number: ANDA204276 ndc (product): 71335-1691
Ergocalciferol	ERGOCALCIFEROL	NuCare Pharmaceuticals,Inc.	b43d7134-6c68-556b-e053-2995a90a38ef	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204276 application number: ANDA204276 ndc (product): 68071-2295

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42806-547	Ergocalciferol Capsules,	Ergocalciferol Capsules,	Epic Pharma LLC	ANDA	Current
42806-547	Ergocalciferol Capsules,	Ergocalciferol Capsules,	Epic Pharma LLC	ANDA	Current
50090-5844	Ergocalciferol	Ergocalciferol Capsules,	A-S Medication Solutions	ANDA	Current
60760-275	Ergocalciferol Capsules,	Ergocalciferol Capsules,	St. Mary's Medical Park Pharmacy	ANDA	Current
63629-7913	Ergocalciferol	Ergocalciferol Capsules,	Bryant Ranch Prepack	ANDA	Current
63629-7913	Ergocalciferol	Ergocalciferol Capsules,	Bryant Ranch Prepack	ANDA	Current
68071-2295	Ergocalciferol	Ergocalciferol	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2295	Ergocalciferol	Ergocalciferol	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2352	Vitamin D	Ergocalciferol	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2352	Vitamin D	Ergocalciferol	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-3472	Ergocalciferol Capsules,	Ergocalciferol Capsules,	REMEDYREPACK INC.	ANDA	Current
70518-3472	Ergocalciferol Capsules,	Ergocalciferol Capsules,	REMEDYREPACK INC.	ANDA	Current
70518-3472	Ergocalciferol Capsules,	Ergocalciferol Capsules,	REMEDYREPACK INC.	ANDA	Current
70934-816	Ergocalciferol Capsules,	Ergocalciferol Capsules,	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71205-676	Ergocalciferol Capsules,	Ergocalciferol Capsules,	Proficient Rx LP	ANDA	Current
71335-1691	Ergocalciferol	Ergocalciferol Capsules,	Bryant Ranch Prepack	ANDA	Current
71335-2003	Ergocalciferol Capsules,	Ergocalciferol Capsules,	Bryant Ranch Prepack	ANDA	Current
80425-0130	DRISDOL	Vitamin D2	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0130	Ergocalciferol (Vitamin D2)	Ergocalciferol (Vitamin D2)	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0130	Ergocalciferol (Vitamin D2)	Ergocalciferol (Vitamin D2)	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current