Rocaltrol

Product NDC: 43353-633
11-digit product format: 433530633
Labeler code: 43353
Product ID: 43353-633_e3436ec4-da38-4e59-a2cf-e573bb00925a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: calcitriol
Dosage form: CAPSULE, GELATIN COATED
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, Inc.
Application: NDA018044
Marketing category: NDA
Marketing start: 2009-08-10
Marketing end: 0000-00-00
Substance: CALCITRIOL
Active strength: 0 ug/1
Pharmacologic classes: Cholecalciferol [CS],Vitamin D3 Analog [EPC]
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	43353-633		I	Inactivated by FDA		2026-08-10
excluded package	package	43353-633	43353-633-81	I	Inactivated by FDA		2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 42 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-633-81	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-633-81	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-633-81	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-633-81	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-633-81	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-633-81	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-633-81	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-633-81	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43353-633-81	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43353-633-81	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43353-633-81	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43353-633-81	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	43353-633-81	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	43353-633-81	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	43353-633-81	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	43353-633-81	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	43353-633-81	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	43353-633-81	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	43353-633-81	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	43353-633-81	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	43353-633-81	`9bebd1f3094a…`	`5416666fcb17…`

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
N018044-001	ROCALTROL	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982
N018044-002	ROCALTROL	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N018044-001	AB
N018044-002	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	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018044-001	ROCALTROL	0.25MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018044-002	ROCALTROL	0.5MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018044-001	ROCALTROL	0.25MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018044-002	ROCALTROL	0.5MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018044-001	ROCALTROL	0.25MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018044-002	ROCALTROL	0.5MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018044-001	ROCALTROL	0.25MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018044-002	ROCALTROL	0.5MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018044-001	ROCALTROL	0.25MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018044-002	ROCALTROL	0.5MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018044-001	ROCALTROL	0.25MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018044-002	ROCALTROL	0.5MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018044-001	ROCALTROL	0.25MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018044-002	ROCALTROL	0.5MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018044-001	ROCALTROL	0.25MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018044-002	ROCALTROL	0.5MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018044-001	ROCALTROL	0.25MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018044-002	ROCALTROL	0.5MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018044-001	ROCALTROL	0.25MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018044-002	ROCALTROL	0.5MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018044-001	ROCALTROL	0.25MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018044-002	ROCALTROL	0.5MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018044-001	ROCALTROL	0.25MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018044-002	ROCALTROL	0.5MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018044-001	ROCALTROL	0.25MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018044-002	ROCALTROL	0.5MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018044-001	ROCALTROL	0.25MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018044-002	ROCALTROL	0.5MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018044-001	ROCALTROL	0.25MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018044-002	ROCALTROL	0.5MCG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018044-001	ROCALTROL	0.25MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018044-002	ROCALTROL	0.5MCG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018044-001	ROCALTROL	0.25MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018044-002	ROCALTROL	0.5MCG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018044-001	ROCALTROL	0.25MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018044-002	ROCALTROL	0.5MCG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018044-001	ROCALTROL	0.25MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018044-002	ROCALTROL	0.5MCG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018044-001	ROCALTROL	0.25MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018044-002	ROCALTROL	0.5MCG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`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	N018044-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018044-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018044-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018044-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018044-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018044-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018044-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018044-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018044-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018044-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018044-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018044-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018044-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018044-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018044-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018044-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018044-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018044-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018044-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018044-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018044-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018044-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018044-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018044-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018044-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018044-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018044-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018044-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018044-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018044-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018044-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018044-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018044-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018044-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018044-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018044-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018044-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018044-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018044-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018044-002	AB	1	`782e0a99824c…`

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
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
98f556da-44be-c658-496e-47884da4e67b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
43353-633-81	2020-01-31	C162847	48780-1	9d75b9d0-6736-f424-e053-dadaa90a57ce	ROCALTROL ® brand of (calcitrol) CAPSULES and ORAL SOLUTION R x only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43353-633-81	Rocaltrol	800 in 1 BOTTLE, PLASTIC	CAPSULE, GELATIN COATED	800		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-633-81	EA - Each	43353-633	413158fb-04af-4485-9e92-e9ae1d2f2ac9	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CALCITRIOL	ACTIVE INGREDIENT	FXC9231JVH	ROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
CALCITRIOL	ACTIVE MOIETY	FXC9231JVH	ROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	ROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	ROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
COCONUT OIL	INACTIVE INGREDIENT	Q9L0O73W7L	ROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	ROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-633	ROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1	Legacy NDC, 1 package rows	20121130_1b2aa7df-0f38-460e-b1f1-d7473be4ab3c.zip

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	1b2aa7df-0f38-460e-b1f1-d7473be4ab3c	1
209006	Rocaltrol 0.25 MCG Oral Capsule	PSN	1b2aa7df-0f38-460e-b1f1-d7473be4ab3c	1
209006	calcitriol 0.00025 MG Oral Capsule [Rocaltrol]	SBD	1b2aa7df-0f38-460e-b1f1-d7473be4ab3c	1
308867	calcitriol 0.00025 MG Oral Capsule	SCD	1b2aa7df-0f38-460e-b1f1-d7473be4ab3c	1
308867	calcitriol 0.25 MCG Oral Capsule	SY	1b2aa7df-0f38-460e-b1f1-d7473be4ab3c	1
209006	Rocaltrol 0.00025 MG Oral Capsule	SY	1b2aa7df-0f38-460e-b1f1-d7473be4ab3c	1
209006	Rocaltrol 0.25 MCG Oral Capsule	SY	1b2aa7df-0f38-460e-b1f1-d7473be4ab3c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
43353-633-81	43353063381	800 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ROCALTROL ® brand of (calcitrol) CAPSULES and ORAL SOLUTION R x only	Aphena Pharma Solutions - Tennessee, Inc.	2012-08-15	HUMAN PRESCRIPTION DRUG LABEL	1