Calcitriol

Product NDC: 62756-967
11-digit product format: 627560967
Labeler code: 62756
Product ID: 62756-967_fb99b865-fb41-4c92-8db9-7953feed2394
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Calcitriol
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA204556
Marketing category: ANDA
Marketing start: 2020-05-01
Substance: CALCITRIOL
Active strength: .25 ug/1
Pharmacologic classes: Cholecalciferol [CS], Vitamin D3 Analog [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
A204556-001	CALCITRIOL	CALCITRIOL	0.25MCG	CAPSULE / ORAL			2019-02-21
A204556-002	CALCITRIOL	CALCITRIOL	0.5MCG	CAPSULE / ORAL			2019-02-21

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	A204556-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL		2019-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204556-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL		2019-02-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204556-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL		2019-02-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204556-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL		2019-02-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204556-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL		2019-02-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204556-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL		2019-02-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204556-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL		2019-02-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204556-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL		2019-02-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204556-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL		2019-02-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204556-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL		2019-02-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204556-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL		2019-02-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204556-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL		2019-02-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204556-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL		2019-02-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204556-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL		2019-02-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204556-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2019-02-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204556-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2019-02-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204556-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL		2019-02-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204556-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL		2019-02-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204556-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2019-02-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204556-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2019-02-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204556-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2019-02-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204556-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2019-02-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204556-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2019-02-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204556-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2019-02-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204556-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2019-02-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204556-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2019-02-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204556-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2019-02-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204556-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2019-02-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204556-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2019-02-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204556-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2019-02-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204556-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2019-02-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204556-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2019-02-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204556-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2019-02-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204556-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2019-02-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204556-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL		2019-02-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204556-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL		2019-02-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204556-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2019-02-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204556-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2019-02-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204556-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2019-02-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204556-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2019-02-21	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 58 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204556-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204556-002	AB	1	`5bbf6a4d5a75…`
2024-10-29 15:01 UTC	2024-10	A204556-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204556-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204556-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204556-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204556-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204556-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204556-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204556-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204556-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204556-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204556-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204556-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204556-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204556-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204556-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204556-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A204556-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204556-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204556-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204556-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204556-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204556-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204556-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A204556-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204556-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A204556-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204556-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A204556-002	AB	1	`c0c555d07b60…`
2019-07-19 19:46 UTC	2019-07	A204556-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A204556-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204556-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204556-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204556-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A204556-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204556-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A204556-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204556-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204556-002	AB	1	`a72a2bbeb626…`

Additional Listing Data#

Finished product: Yes
Brand name base: Calcitriol
Listing expiration: 2026-12-31

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
97cf7807-3b48-403b-bae2-2fe585946e0c	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
5f07db61-095c-acca-e8e9-d0916b4c1947	Product name	2	20200616
98f556da-44be-c658-496e-47884da4e67b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
62756-967-18	Calcitriol	1000 in 1 BOTTLE	CAPSULE, LIQUID FILLED	1000	4
62756-967-83	Calcitriol	30 in 1 BOTTLE	CAPSULE, LIQUID FILLED	30	4
62756-967-88	Calcitriol	100 in 1 BOTTLE	CAPSULE, LIQUID FILLED	100	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62756-967	CALCITRIOL CAPSULE, LIQUID FILLED [SUN PHARMACEUTICAL INDUSTRIES, INC.]	4	Current NDC, Legacy NDC, 3 package rows	20220118_97cf7807-3b48-403b-bae2-2fe585946e0c.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calcitriol	CALCITRIOL	Sun Pharmaceutical Industries, Inc.	97cf7807-3b48-403b-bae2-2fe585946e0c	2022-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204556 application number: ANDA204556 ndc (product): 62756-967

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	97cf7807-3b48-403b-bae2-2fe585946e0c	4
308868	calcitriol 0.5 MCG Oral Capsule	PSN	97cf7807-3b48-403b-bae2-2fe585946e0c	4
308867	calcitriol 0.00025 MG Oral Capsule	SCD	97cf7807-3b48-403b-bae2-2fe585946e0c	4
308868	calcitriol 0.0005 MG Oral Capsule	SCD	97cf7807-3b48-403b-bae2-2fe585946e0c	4
308867	calcitriol 0.25 MCG Oral Capsule	SY	97cf7807-3b48-403b-bae2-2fe585946e0c	4
308868	calcitriol 0.5 MCG Oral Capsule	SY	97cf7807-3b48-403b-bae2-2fe585946e0c	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
62756-967-18	62756096718	1000 CAPSULE, LIQUID FILLED in 1 BOTTLE (62756-967-18)	2020-05-01	0000-00-00	No	No	Current
62756-967-83	62756096783	30 CAPSULE, LIQUID FILLED in 1 BOTTLE (62756-967-83)	2020-05-01	0000-00-00	No	No	Current
62756-967-88	62756096788	100 CAPSULE, LIQUID FILLED in 1 BOTTLE (62756-967-88)	2020-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Calcitriol Capsules Rx only	Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Industries Limited	2022-01-17	Human Prescription Drug Label	4