Calcitriol

Product NDC: 0093-7352
11-digit product format: 000937352
Labeler code: 0093
Product ID: 0093-7352_9e6df585-e3d1-4a89-bc02-8e4b223578c4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Calcitriol
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA075765
Marketing category: ANDA
Marketing start: 2016-08-25
Marketing end: 2027-02-28
Substance: CALCITRIOL
Active strength: .25 ug/1
Pharmacologic classes: Cholecalciferol [CS], Vitamin D3 Analog [EPC]
NDC exclude flag: No
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A075765-001	CALCITRIOL	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2001-10-12
A075765-002	CALCITRIOL	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB		2001-10-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075765-001	AB
A075765-002	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 · 86 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	A075765-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2001-10-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075765-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2001-10-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075765-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2001-10-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075765-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2001-10-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075765-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2001-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075765-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2001-10-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075765-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2001-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075765-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2001-10-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075765-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2001-10-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075765-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2001-10-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075765-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2001-10-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075765-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2001-10-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075765-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2001-10-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075765-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2001-10-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075765-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2001-10-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075765-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2001-10-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075765-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2001-10-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075765-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2001-10-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075765-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2001-10-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075765-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2001-10-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075765-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2001-10-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075765-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2001-10-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075765-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2001-10-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075765-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2001-10-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075765-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2001-10-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075765-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2001-10-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075765-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2001-10-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075765-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2001-10-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075765-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2001-10-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075765-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2001-10-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075765-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2001-10-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075765-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2001-10-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075765-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2001-10-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075765-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2001-10-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075765-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2001-10-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075765-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2001-10-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075765-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2001-10-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075765-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2001-10-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075765-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2001-10-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075765-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2001-10-12	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A075765-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075765-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075765-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075765-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075765-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075765-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075765-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075765-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075765-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075765-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075765-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075765-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075765-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075765-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075765-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075765-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075765-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075765-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075765-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075765-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075765-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A075765-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075765-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A075765-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075765-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075765-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075765-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075765-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075765-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075765-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075765-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075765-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075765-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A075765-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075765-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A075765-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075765-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075765-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075765-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A075765-002	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Calcitriol

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CALCITRIOL	.25 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
FXC9231JVH	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
308867	Internal RxNorm lookup
308868	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ec93b667-aad2-4e3a-adc6-952f070a0c0a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
09b728d3-9521-67a6-95fe-30969d1d5187	Product name	5	20240828
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
5f07db61-095c-acca-e8e9-d0916b4c1947	Product name	2	20200616
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
98f556da-44be-c658-496e-47884da4e67b	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0093-7352-01	Calcitriol	100 in 1 BOTTLE	CAPSULE, LIQUID FILLED	100		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-7352-01	EA - Each	0093-7352	bd51ecea-6c89-429d-9b95-7e46a06acebc	1	2016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0093-7352	CALCITRIOL CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA, INC.]	7	Current NDC, Legacy NDC, 1 package rows	20220721_ec93b667-aad2-4e3a-adc6-952f070a0c0a.zip

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	34f53d71-78b0-5237-e063-6294a90a2bbd	2025-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075765 application number: ANDA075765
Calcitriol	CALCITRIOL	Bryant Ranch Prepack	38a676c3-c6c6-4008-87df-f32e1cbaba9b	2024-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075765 application number: ANDA075765
Calcitriol	CALCITRIOL	Bryant Ranch Prepack	6c68beb7-1fed-4652-b4e1-672fde0b621d	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075765 application number: ANDA075765
Calcitriol	CALCITRIOL	Bryant Ranch Prepack	7e0574e0-3a41-486a-be37-92ab56b7f81f	2023-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075765 application number: ANDA075765
Calcitriol	CALCITRIOL	Teva Pharmaceuticals USA, Inc.	ec93b667-aad2-4e3a-adc6-952f070a0c0a	2019-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075765 application number: ANDA075765 ndc (product): 0093-7352

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
FXC9231JVH	CALCITRIOL	32222-06-3	CALCITRIOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
308867	calcitriol 0.25 MCG Oral Capsule	PSN	38a676c3-c6c6-4008-87df-f32e1cbaba9b	105
308867	calcitriol 0.00025 MG Oral Capsule	SCD	38a676c3-c6c6-4008-87df-f32e1cbaba9b	105
308867	calcitriol 0.25 MCG Oral Capsule	SY	38a676c3-c6c6-4008-87df-f32e1cbaba9b	105
308867	calcitriol 0.25 MCG Oral Capsule	PSN	34f53d71-78b0-5237-e063-6294a90a2bbd	100
308867	calcitriol 0.00025 MG Oral Capsule	SCD	34f53d71-78b0-5237-e063-6294a90a2bbd	100
308867	calcitriol 0.25 MCG Oral Capsule	SY	34f53d71-78b0-5237-e063-6294a90a2bbd	100
308867	calcitriol 0.25 MCG Oral Capsule	PSN	ec93b667-aad2-4e3a-adc6-952f070a0c0a	8
308868	calcitriol 0.5 MCG Oral Capsule	PSN	ec93b667-aad2-4e3a-adc6-952f070a0c0a	8
308867	calcitriol 0.00025 MG Oral Capsule	SCD	ec93b667-aad2-4e3a-adc6-952f070a0c0a	8
308868	calcitriol 0.0005 MG Oral Capsule	SCD	ec93b667-aad2-4e3a-adc6-952f070a0c0a	8
308867	calcitriol 0.25 MCG Oral Capsule	SY	ec93b667-aad2-4e3a-adc6-952f070a0c0a	8
308868	calcitriol 0.5 MCG Oral Capsule	SY	ec93b667-aad2-4e3a-adc6-952f070a0c0a	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0093-7352-01	00093735201	100 CAPSULE, LIQUID FILLED in 1 BOTTLE (0093-7352-01)	2016-08-25	2027-02-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CALCITRIOL CAPSULES, 0.25 mcg and 0.5 mcg Rx only	Bryant Ranch Prepack	2025-05-12	HUMAN PRESCRIPTION DRUG LABEL	100
CALCITRIOL CAPSULES, 0.25 mcg and 0.5 mcg Rx only	Bryant Ranch Prepack	2024-08-20	HUMAN PRESCRIPTION DRUG LABEL	105
CALCITRIOL CAPSULES, 0.25 mcg and 0.5 mcg Rx only	Bryant Ranch Prepack	2022-05-23	HUMAN PRESCRIPTION DRUG LABEL	100
CALCITRIOL CAPSULES, 0.25 mcg and 0.5 mcg Rx only	Teva Pharmaceuticals USA, Inc.	2019-08-01	HUMAN PRESCRIPTION DRUG LABEL	8