Calcitriol Oral Capsule
- Brand(s)
- Rocaltrol
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Validus Pharmaceuticals Llc (2010-08-01)
- Oldest Current Product
- 2001-10-15
- License(s)
- NDA, NDA AUTHORIZED GENERIC, ANDA
- RxNORM
- ORAL CAPSULE\CALCITRIOL
- FDAOB
- ORAL\CAPSULE\CALCITRIOL
- SPL Active
- ORAL\CAPSULE, GELATIN COATED\CALCITRIOL
ORAL\CAPSULE, LIQUID FILLED\CALCITRIOL
ORAL\CAPSULE\CALCITRIOL - SPL Moiety
- ORAL\CAPSULE, GELATIN COATED\CALCITRIOL
ORAL\CAPSULE, LIQUID FILLED\CALCITRIOL
ORAL\CAPSULE\CALCITRIOL
product(s) by strength(s)
calcitriol 0.00025 mg oral capsule
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 306980143 | Rocaltrol | NDA | Validus Pharmaceuticals Llc | 2009-08-10 | CALCITRIOL | ORAL | CAPSULE, GELATIN COATED | NDA018044 | d1013494-bf62-4e68-9f0c-e6571137f20f |
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 000540007 | ANDA | Roxane Laboratories, Inc | 2006-03-27 | CALCITRIOL | ORAL | CAPSULE | ANDA076917 | cdcaffc6-e14e-4607-b77b-fc78a8382f60 |
| 2 | 000930657 | ANDA | Teva Pharmaceuticals Usa Inc | 2001-10-15 | CALCITRIOL | ORAL | CAPSULE, LIQUID FILLED | ANDA075765 | ae2d0165-1b19-4406-9f28-f4b1579c3dbf |
| 3 | 231550118 | ANDA | Heritage Pharmaceuticals Inc. | 2013-05-29 | CALCITRIOL | ORAL | CAPSULE, LIQUID FILLED | ANDA091174 | aaf62f0f-bd93-43f1-96f2-e4f001ea7328 |
| 4 | 633040239 | NDA AUTHORIZED GENERIC | Rnabaxy Pharmaceuticals Inc. | 2009-08-26 | CALCITRIOL | ORAL | CAPSULE | NDA018044 | 66a69351-5b09-4368-a9fa-acf81b5ad882 |
| 5 | 643800723 | ANDA | Strides Arcolab Limited | 2015-01-06 | CALCITRIOL | ORAL | CAPSULE | ANDA091356 | bebefb2a-7365-48e2-9681-83ed4b41e26e |
relabeler product(s)(s)
| # | id | brand | category | labeler | first marketed | last marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 001790069 | Rocaltrol | NDA | Kaiser Foundations Hospitals | 2010-08-09 | CALCITRIOL | ORAL | CAPSULE, GELATIN COATED | 306980143 | NDA018044 | e26e13c4-7e45-4e66-8c0d-7fc68e24cdd5 | |
| 2 | 433530034 | ANDA | Aphena Pharma Solutions - Tennessee, Llc | 2006-03-27 | CALCITRIOL | ORAL | CAPSULE | 000540007 | ANDA076917 | 167a669f-7b7e-46ea-9331-567bf19d8787 | ||
| 3 | 433530633 | Rocaltrol | NDA | Aphena Pharma Solutions - Tennessee, Llc | 2009-08-10 | CALCITRIOL | ORAL | CAPSULE, GELATIN COATED | 306980143 | NDA018044 | 1b2aa7df-0f38-460e-b1f1-d7473be4ab3c | |
| 4 | 548684584 | ANDA | Physicians Total Care, Inc. | 2005-12-02 | CALCITRIOL | ORAL | CAPSULE, LIQUID FILLED | 000930657 | ANDA075765 | 84262b69-df29-41d0-9e97-6e1188096aeb | ||
| 5 | 551548251 | ANDA | Cardinal Health | 2009-10-29 | CALCITRIOL | ORAL | CAPSULE, LIQUID FILLED | 000930657 | ANDA075765 | d3d69786-ac48-4a71-bbd8-83172e86d577 | ||
| 6 | 604290133 | ANDA | Golden State Medical Supply, Inc. | 2014-12-26 | CALCITRIOL | ORAL | CAPSULE, LIQUID FILLED | 231550118 | ANDA091174 | 362ec5a9-a269-4300-ae8f-f454252cf169 | ||
| 7 | 663360851 | NDA AUTHORIZED GENERIC | Dispensing Solutions, Inc. | 2009-08-26 | CALCITRIOL | ORAL | CAPSULE | 633040239 | NDA018044 | c64778c6-3be6-44f5-8387-ebcd82e3eae5 | ||
| 8 | 680840475 | ANDA | American Health Packaging | 2012-03-01 | 2016-11-30 | CALCITRIOL | ORAL | CAPSULE | 000540007 | ANDA076917 | 517f23e8-4ad5-46e7-8dc4-473d5dcb09c8 | |
| 9 | 681510088 | NDA AUTHORIZED GENERIC | Carilion Materials Management | 2009-08-26 | CALCITRIOL | ORAL | CAPSULE | 633040239 | NDA018044 | 2d755a21-9f42-4d36-aaec-962495ab2f2b |
calcitriol 0.0005 mg oral capsule
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 000930658 | ANDA | Teva Pharmaceuticals Usa Inc | 2001-10-15 | CALCITRIOL | ORAL | CAPSULE, LIQUID FILLED | ANDA075765 | ae2d0165-1b19-4406-9f28-f4b1579c3dbf |
| 2 | 231550119 | ANDA | Heritage Pharmaceuticals Inc. | 2013-05-29 | CALCITRIOL | ORAL | CAPSULE, LIQUID FILLED | ANDA091174 | aaf62f0f-bd93-43f1-96f2-e4f001ea7328 |
| 3 | 633040240 | NDA AUTHORIZED GENERIC | Rnabaxy Pharmaceuticals Inc. | 2009-08-26 | CALCITRIOL | ORAL | CAPSULE | NDA018044 | 66a69351-5b09-4368-a9fa-acf81b5ad882 |
relabeler product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 548684582 | ANDA | Physicians Total Care, Inc. | 2010-03-01 | CALCITRIOL | ORAL | CAPSULE, LIQUID FILLED | 000930658 | ANDA075765 | 84262b69-df29-41d0-9e97-6e1188096aeb |
| 2 | 551548281 | ANDA | Cardinal Health | 2009-10-29 | CALCITRIOL | ORAL | CAPSULE, LIQUID FILLED | 000930658 | ANDA075765 | d3d69786-ac48-4a71-bbd8-83172e86d577 |
| 3 | 604290134 | ANDA | Golden State Medical Supply, Inc. | 2014-12-26 | CALCITRIOL | ORAL | CAPSULE, LIQUID FILLED | 231550119 | ANDA091174 | 362ec5a9-a269-4300-ae8f-f454252cf169 |
application(s)
| # | id | title | applicant | approved | approved drug |
|---|---|---|---|---|---|
| 1 | ANDA075765 | CALCITRIOL | TEVA PHARMACEUTICALS USA INC | 2001-10-12 | ANDA075765_001, ANDA075765_002 |
| 2 | ANDA076917 | CALCITRIOL | ROXANE LABORATORIES INC | 2006-03-27 | ANDA076917_001 |
| 3 | ANDA091174 | CALCITRIOL | BANNER LIFE SCIENCES LLC | 2013-05-24 | ANDA091174_001, ANDA091174_002 |
| 4 | ANDA091356 | CALCITRIOL | STRIDES PHARMA GLOBAL PTE LTD | 2014-12-12 | ANDA091356_001, ANDA091356_002 |
| 5 | NDA018044 | ROCALTROL | VALIDUS PHARMACEUTICALS LLC | NDA018044_001, NDA018044_002 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|---|
| 1 | ANDA075765_001 | RX | CALCITRIOL (0.25MCG) | ORAL | CAPSULE | False | AB | 2001-10-12 | CALCITRIOL |
| 2 | ANDA075765_002 | RX | CALCITRIOL (0.5MCG) | ORAL | CAPSULE | False | AB | 2001-10-12 | CALCITRIOL |
| 3 | ANDA076917_001 | RX | CALCITRIOL (0.25MCG) | ORAL | CAPSULE | False | AB | 2006-03-27 | CALCITRIOL |
| 4 | ANDA091174_001 | RX | CALCITRIOL (0.25MCG) | ORAL | CAPSULE | False | AB | 2013-05-24 | CALCITRIOL |
| 5 | ANDA091174_002 | RX | CALCITRIOL (0.5MCG) | ORAL | CAPSULE | False | AB | 2013-05-24 | CALCITRIOL |
| 6 | ANDA091356_001 | RX | CALCITRIOL (0.25MCG) | ORAL | CAPSULE | False | AB | 2014-12-12 | CALCITRIOL |
| 7 | ANDA091356_002 | RX | CALCITRIOL (0.5MCG) | ORAL | CAPSULE | False | AB | 2014-12-12 | CALCITRIOL |
| 8 | NDA018044_001 | RX | CALCITRIOL (0.25MCG) | ORAL | CAPSULE | False | AB | ROCALTROL | |
| 9 | NDA018044_002 | RX | CALCITRIOL (0.5MCG) | ORAL | CAPSULE | True | AB | ROCALTROL |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) | in other drug docs |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 167a669f-7b7e-46ea-9331-567bf19d8787 (view SPL) | CALCITRIOL Capsules | prescription | Human Prescription | Aphena Pharma Solutions - Tennessee, Llc | Repack | 2014-03-27 | 2 | 433530034 | |
| 2 | 1b2aa7df-0f38-460e-b1f1-d7473be4ab3c (view SPL) | ROCALTROL brand of (calcitrol) CAPSULES and ORAL SOLUTION Rx only | prescription | Human Prescription | Aphena Pharma Solutions - Tennessee, Llc | Repack | 2012-08-15 | 1 | 433530633 | |
| 3 | 2d755a21-9f42-4d36-aaec-962495ab2f2b (view SPL) | CALCITRIOL CAPSULES and ORAL SOLUTION Rx only | prescription | Human Prescription | Carilion Materials Management | REPACK | 2011-08-31 | 2 | 681510088 | |
| 4 | 362ec5a9-a269-4300-ae8f-f454252cf169 (view SPL) | Calcitriol capsule, Liquid Filled Rx only | prescription | Human Prescription | Golden State Medical Supply, Inc. | RELABEL, REPACK | 2015-05-08 | 3 | 604290133, 604290134 | |
| 5 | 517f23e8-4ad5-46e7-8dc4-473d5dcb09c8 (view SPL) | CALCITRIOL Capsules | prescription | Human Prescription | American Health Packaging | repack | 2015-10-01 | 4 | 680840475 | |
| 6 | 66a69351-5b09-4368-a9fa-acf81b5ad882 (view SPL) | CALCITRIOL CAPSULES and ORAL SOLUTIONRx only | prescription | Human Prescription | Rnabaxy Pharmaceuticals Inc. | manufacture | 2011-08-31 | 2 | 633040239, 633040240, 633040241 | Calcitriol Oral Solution |
| 7 | 84262b69-df29-41d0-9e97-6e1188096aeb (view SPL) | prescription | Human Prescription | Physicians Total Care, Inc. | relabel, repack | 2010-03-09 | 1 | 548684582, 548684584 | ||
| 8 | aaf62f0f-bd93-43f1-96f2-e4f001ea7328 (view SPL) | Calcitriol capsule, Liquid Filled Rx only | prescription | Human Prescription | Heritage Pharmaceuticals Inc. | MANUFACTURE | 2014-02-28 | 6 | 231550118, 231550119 | |
| 9 | ae2d0165-1b19-4406-9f28-f4b1579c3dbf (view SPL) | CALCITRIOL CAPSULES, 0.25 mcg and 0.5 mcg06570658Rx only | prescription | Human Prescription | Teva Pharmaceuticals Usa Inc | 2014-01-30 | 5 | 000930657, 000930658 | ||
| 10 | bebefb2a-7365-48e2-9681-83ed4b41e26e (view SPL) | Calcitriol Capsules (0.25 mcg & 0.5 mcg) | prescription | Human Prescription | Strides Arcolab Limited | manufacture | 2015-01-06 | 3 | 643800723 | |
| 11 | c64778c6-3be6-44f5-8387-ebcd82e3eae5 (view SPL) | CALCITRIOL CAPSULES and ORAL SOLUTIONRx only | prescription | Human Prescription | Dispensing Solutions, Inc. | relabel, repack | 2013-06-07 | 1 | 663360851 | |
| 12 | cdcaffc6-e14e-4607-b77b-fc78a8382f60 (view SPL) | CALCITRIOL Capsules | prescription | Human Prescription | Roxane Laboratories, Inc | API MANUFACTURE, MANUFACTURE | 2012-01-26 | 8 | 000540007 | |
| 13 | d1013494-bf62-4e68-9f0c-e6571137f20f (view SPL) | ROCALTROL brand of (calcitrol) CAPSULES and ORAL SOLUTION Rx only | prescription | Human Prescription | Validus Pharmaceuticals Llc | manufacture | 2010-08-01 | 2 | 306980143 | |
| 14 | d3d69786-ac48-4a71-bbd8-83172e86d577 (view SPL) | CALCITRIOL CAPSULES, 0.25 mcg and 0.5 mcg06570658Rx only | prescription | Human Prescription | Cardinal Health | REPACK | 2014-07-22 | 4 | 551548251, 551548281 | |
| 15 | e26e13c4-7e45-4e66-8c0d-7fc68e24cdd5 (view SPL) | ROCALTROLbrand of(calcitriol)CAPSULES Rx Only | prescription | Human Prescription | Kaiser Foundations Hospitals | repack | 2010-08-16 | 2 | 001790069 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII