Application 090455

Type: ANDA
Sponsor: STRIDES PHARMA

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
A090455-001	ERGOCALCIFEROL	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	RS	2010-08-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090455-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	RS	2010-08-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	RS	2010-08-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	RS	2010-08-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	RS	2010-08-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	RS	2010-08-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	RS	2010-08-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	RS	2010-08-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	RS	2010-08-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	RS	2010-08-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	RS	2010-08-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	RS	2010-08-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	RS	2010-08-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	RS	2010-08-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	RS	2010-08-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA		2010-08-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA		2010-08-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA		2010-08-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA		2010-08-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA		2010-08-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA		2010-08-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA		2010-08-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA		2010-08-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA		2010-08-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA		2010-08-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA		2010-08-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA		2010-08-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA		2010-08-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	RS	2010-08-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	RS	2010-08-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	RS	2010-08-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	RS	2010-08-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	RS	2010-08-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	RS	2010-08-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	RS	2010-08-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA	RS	2010-08-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA		2010-08-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA		2010-08-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA		2010-08-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA		2010-08-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090455-001	ERGOCALCIFEROL	50,000 IU	CAPSULE / ORAL	AA		2010-08-03	`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	A090455-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090455-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090455-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090455-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090455-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090455-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090455-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090455-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090455-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090455-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090455-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090455-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090455-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090455-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090455-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090455-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090455-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090455-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090455-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090455-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090455-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090455-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090455-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090455-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090455-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090455-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090455-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090455-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090455-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090455-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090455-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090455-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090455-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090455-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090455-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090455-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090455-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090455-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090455-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090455-001	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 · 10 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	Exact identifier application applno (ANDA): 090455 application number: ANDA090455 ndc (product): 70518-1878
VITAMIN D	ERGOCALCIFEROL	Aphena Pharma Solutions - Tennessee, LLC	3c0f4142-cc1f-43de-8677-ee06b6f4fc10	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090455 application number: ANDA090455 ndc (product): 71610-552
VITAMIN D	ERGOCALCIFEROL	AvPAK	a2b82923-f0dd-641f-e053-2995a90a7c4a	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090455 application number: ANDA090455 ndc (product): 50268-297
VITAMIN D	ERGOCALCIFEROL	Northwind Health Company, LLC	f3402462-5d86-b4c9-e053-2a95a90aaab0	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090455 application number: ANDA090455
VITAMIN D	ERGOCALCIFEROL	Preferred Pharmaceuticals, Inc.	ba2076ef-1650-45e1-b092-a4c449dd6210	2025-10-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090455 application number: ANDA090455 ndc (product): 68788-7627
VITAMIN D	ERGOCALCIFEROL	Golden State Medical Supply, Inc.	26aba724-8990-def9-e063-6394a90a991d	2025-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090455 application number: ANDA090455
VITAMIN D	ERGOCALCIFEROL	PD-Rx Pharmaceuticals, Inc.	7e9b75e3-eb7c-4227-b953-166ac6897e54	2025-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090455 application number: ANDA090455 ndc (product): 72789-249
VITAMIN D	ERGOCALCIFEROL	Strides Pharma Science Limited	2c4c0a36-12cf-444d-9d57-de983eef4d36	2025-03-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090455 application number: ANDA090455 ndc (product): 64380-737
VITAMIN D	ERGOCALCIFEROL	Bryant Ranch Prepack	a8aa37f4-7e94-4425-beea-49c938294a23	2024-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090455 application number: ANDA090455 ndc (product): 71335-0278
VITAMIN D	ERGOCALCIFEROL	Proficient Rx LP	548365c1-b51c-4a8b-ae3d-50b41aba12db	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090455 application number: ANDA090455 ndc (product): 63187-519

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
23155-809	VITAMIN D	ergocalciferol	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
50090-3201	VITAMIN D	ergocalciferol	A-S Medication Solutions	ANDA	Current
50268-297	VITAMIN D	ergocalciferol	AvPAK	ANDA	Current
50268-297	VITAMIN D	ergocalciferol	AvPAK	ANDA	Current
53217-287	VITAMIN D	ergocalciferol	Aidarex Pharmaceuticals LLC	ANDA	Current
63187-519	VITAMIN D	ergocalciferol	Proficient Rx LP	ANDA	Current
63187-519	VITAMIN D	ergocalciferol	Proficient Rx LP	ANDA	Current
63187-519	VITAMIN D	ergocalciferol	Proficient Rx LP	ANDA	Current
63187-519	VITAMIN D	ergocalciferol	Proficient Rx LP	ANDA	Current
64380-737	VITAMIN D	ergocalciferol	Strides Pharma Science Limited	ANDA	Current
68788-6409	VITAMIN D	ergocalciferol	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7627	VITAMIN D	ergocalciferol	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7627	VITAMIN D	ergocalciferol	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7627	VITAMIN D	ergocalciferol	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-1878	VITAMIN D	ergocalciferol	REMEDYREPACK INC.	ANDA	Current
70518-1878	VITAMIN D	ergocalciferol	REMEDYREPACK INC.	ANDA	Current
70518-1878	VITAMIN D	ergocalciferol	REMEDYREPACK INC.	ANDA	Current
70518-1878	VITAMIN D	ergocalciferol	REMEDYREPACK INC.	ANDA	Current
70518-1878	VITAMIN D	ergocalciferol	REMEDYREPACK INC.	ANDA	Current
70518-1878	VITAMIN D	ergocalciferol	REMEDYREPACK INC.	ANDA	Current
71335-0278	VITAMIN D	ergocalciferol	Bryant Ranch Prepack	ANDA	Current
71335-0278	VITAMIN D	ergocalciferol	Bryant Ranch Prepack	ANDA	Current
71610-552	VITAMIN D	ergocalciferol	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
72789-249	VITAMIN D	ergocalciferol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current