Application 091174

Type: ANDA
Sponsor: BIONPHARMA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CALCITRIOL	CALCITRIOL	CAPSULE;ORAL	0.25MCG	No	No
002	CALCITRIOL	CALCITRIOL	CAPSULE;ORAL	0.5MCG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091174-001	CALCITRIOL	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2013-05-24
A091174-002	CALCITRIOL	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB		2013-05-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A091174-001	AB
A091174-002	AB

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 3 · 82 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	A091174-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2013-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091174-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2013-05-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091174-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2013-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091174-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2013-05-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091174-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2013-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091174-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2013-05-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091174-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2013-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091174-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2013-05-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091174-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2013-05-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091174-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2013-05-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091174-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2013-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091174-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2013-05-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091174-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2013-05-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091174-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2013-05-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091174-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2013-05-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091174-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2013-05-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091174-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2013-05-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091174-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2013-05-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091174-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2013-05-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091174-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2013-05-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091174-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2013-05-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091174-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2013-05-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091174-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2013-05-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091174-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2013-05-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091174-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2013-05-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091174-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2013-05-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091174-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2013-05-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091174-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2013-05-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091174-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2013-05-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091174-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2013-05-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091174-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2013-05-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091174-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2013-05-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091174-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2013-05-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091174-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2013-05-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091174-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2013-05-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091174-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2013-05-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091174-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2013-05-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091174-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2013-05-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091174-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2013-05-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091174-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2013-05-24	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A091174-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091174-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091174-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091174-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091174-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091174-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091174-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091174-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091174-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091174-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091174-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091174-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091174-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091174-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091174-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091174-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091174-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091174-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091174-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091174-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091174-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091174-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091174-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091174-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091174-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091174-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091174-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091174-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091174-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091174-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091174-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091174-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091174-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091174-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091174-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091174-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091174-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091174-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091174-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091174-002	AB	1	`782e0a99824c…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calcitriol	CALCITRIOL	Bryant Ranch Prepack	bf621b22-b783-416f-aee3-e0dbfdb782ca	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091174 application number: ANDA091174 ndc (product): 71335-1782
Calcitriol	CALCITRIOL	Golden State Medical Supply, Inc.	8465337c-86ca-ea9d-e053-2991aa0ab167	2026-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091174 application number: ANDA091174 ndc (product): 51407-170 ndc (product): 51407-169
Calcitriol	CALCITRIOL	BIONPHARMA INC.	626f23d5-31e6-41ca-a696-191a4f2bc7ef	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091174 application number: ANDA091174 ndc (product): 69452-207 ndc (product): 69452-208
Calcitriol	CALCITRIOL	A-S Medication Solutions	b57feb9f-2c5c-4d1c-9330-09c6e9fed95c	2023-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091174 application number: ANDA091174
Calcitriol	CALCITRIOL	Aphena Pharma Solutions - Tennessee, LLC	3c40c40c-1627-4bcd-ba35-bee9b952d985	2023-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091174 application number: ANDA091174 ndc (product): 71610-468

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
23155-118	Calcitriol	Calcitriol	Heritage Pharmaceuticals Inc	ANDA	Current
23155-119	Calcitriol	Calcitriol	Heritage Pharmaceuticals Inc	ANDA	Current
43353-998	Calcitriol	Calcitriol	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
51407-169	Calcitriol	Calcitriol	Golden State Medical Supply Inc.	ANDA	Current
51407-169	Calcitriol	Calcitriol	Golden State Medical Supply Inc.	ANDA	Current
51407-170	Calcitriol	Calcitriol	Golden State Medical Supply Inc.	ANDA	Current
51407-170	Calcitriol	Calcitriol	Golden State Medical Supply Inc.	ANDA	Current
63629-2445	Calcitriol	Calcitriol	Bryant Ranch Prepack	ANDA	Current
63629-2445	Calcitriol	Calcitriol	Bryant Ranch Prepack	ANDA	Current
68071-4487	Calcitriol	Calcitriol	NuCare Pharmaceuticals,Inc.	ANDA	Current
69452-207	Calcitriol	Calcitriol	BIONPHARMA INC.	ANDA	Current
69452-208	Calcitriol	Calcitriol	BIONPHARMA INC.	ANDA	Current
71335-0443	Calcitriol	Calcitriol	Bryant Ranch Prepack	ANDA	Current
71335-0901	Calcitriol	Calcitriol	Bryant Ranch Prepack	ANDA	Current
71335-0901	Calcitriol	Calcitriol	Bryant Ranch Prepack	ANDA	Current
71335-1782	Calcitriol	Calcitriol	Bryant Ranch Prepack	ANDA	Current
71610-468	Calcitriol	Calcitriol	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current