Acarbose Oral Tablet
- Brand(s)
- Precose
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Bayer Healthcare Pharmaceuticals Inc. (2015-03-11)
- Oldest Current Product
- 2007-11-19
- License(s)
- NDA, NDA AUTHORIZED GENERIC, ANDA
- RxNORM
- ORAL TABLET\ACARBOSE
- FDAOB
- ORAL\TABLET\ACARBOSE
- SPL Active
- ORAL\TABLET\ACARBOSE
- SPL Moiety
- ORAL\TABLET\ACARBOSE
product(s) by strength(s)
acarbose 100 mg oral tablet
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 504190862 | Precose | NDA | Bayer Healthcare Pharmaceuticals Inc. | 2008-01-30 | ACARBOSE | ORAL | TABLET | NDA020482 | 29a6f213-bc93-4dbd-bab0-744722b6f0b8 |
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 000540142 | ANDA | Roxane Laboratories, Inc | 2008-05-07 | ACARBOSE | ORAL | TABLET | ANDA078470 | 352dd336-d3f9-4ac5-a000-91d3aef7aca3 |
| 2 | 001151152 | ANDA | Global Pharmaceuticals | 2009-05-14 | ACARBOSE | ORAL | TABLET | ANDA078441 | c41eaba7-49d5-43a4-9e4e-1ebc4da28982 |
| 3 | 003782822 | ANDA | Mylan Pharmaceuticals Inc. | 2011-01-06 | ACARBOSE | ORAL | TABLET | ANDA091053 | b56f1c19-b798-46d2-9ad1-73816ed86ef3 |
| 4 | 162520525 | ANDA | Actavis Pharma, Inc. | 2008-05-07 | ACARBOSE | ORAL | TABLET | ANDA077532 | 6c2db888-775c-4baf-a1b4-1cfa63b83357 |
| 5 | 231550149 | ANDA | Heritage Pharmaceuticals Inc. | 2012-07-30 | ACARBOSE | ORAL | TABLET | ANDA202271 | 29939129-7d09-4c22-bf3e-491a8a97f4c4 |
| 6 | 477810342 | NDA AUTHORIZED GENERIC | Alvogen, Inc. | 2008-01-30 | ACARBOSE | ORAL | TABLET | NDA020482 | e4148493-e3bd-4530-8fb6-cdb5197c010e |
| 7 | 695430122 | ANDA | Virtus Pharmaceuticals | 2015-02-01 | ACARBOSE | ORAL | TABLET | ANDA091343 | 6cd185e6-3205-484c-be49-456acfc7eb11 |
| 8 | 764390122 | ANDA | Virtus Pharmaceuticals | 2013-10-09 | ACARBOSE | ORAL | TABLET | ANDA091343 | f87e7022-0129-4a01-9bd6-1205ae9c05cb |
relabeler product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 422910132 | ANDA | Avkare, Inc. | 2013-12-24 | ACARBOSE | ORAL | TABLET | 695430122 | ANDA091343 | 858c8cdd-ccf1-79c9-c245-7a852d280f20 |
acarbose 25 mg oral tablet
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 504190863 | Precose | NDA | Bayer Healthcare Pharmaceuticals Inc. | 2008-01-30 | ACARBOSE | ORAL | TABLET | NDA020482 | 29a6f213-bc93-4dbd-bab0-744722b6f0b8 |
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 000540140 | ANDA | Roxane Laboratories, Inc | 2008-05-07 | ACARBOSE | ORAL | TABLET | ANDA078470 | 352dd336-d3f9-4ac5-a000-91d3aef7aca3 |
| 2 | 001151150 | ANDA | Global Pharmaceuticals | 2009-05-14 | ACARBOSE | ORAL | TABLET | ANDA078441 | c41eaba7-49d5-43a4-9e4e-1ebc4da28982 |
| 3 | 003782820 | ANDA | Mylan Pharmaceuticals Inc. | 2011-01-06 | ACARBOSE | ORAL | TABLET | ANDA091053 | b56f1c19-b798-46d2-9ad1-73816ed86ef3 |
| 4 | 162520523 | ANDA | Actavis Pharma, Inc. | 2008-05-07 | ACARBOSE | ORAL | TABLET | ANDA077532 | 6c2db888-775c-4baf-a1b4-1cfa63b83357 |
| 5 | 231550147 | ANDA | Heritage Pharmaceuticals Inc. | 2012-07-30 | ACARBOSE | ORAL | TABLET | ANDA202271 | 29939129-7d09-4c22-bf3e-491a8a97f4c4 |
| 6 | 477810340 | NDA AUTHORIZED GENERIC | Alvogen, Inc. | 2008-01-30 | ACARBOSE | ORAL | TABLET | NDA020482 | e4148493-e3bd-4530-8fb6-cdb5197c010e |
| 7 | 518620210 | ANDA | Libertas Pharma, Inc. | 2011-07-27 | ACARBOSE | ORAL | TABLET | ANDA090912 | dbb04848-93e2-42ca-a709-6a396913507e |
| 8 | 643800758 | ANDA | Strides Arcolab Limited | 2011-07-28 | ACARBOSE | ORAL | TABLET | ANDA090912 | 656769ee-e292-4950-83df-a38e6b1a9d6e |
| 9 | 695430120 | ANDA | Virtus Pharmaceuticals | 2015-02-01 | ACARBOSE | ORAL | TABLET | ANDA091343 | 6cd185e6-3205-484c-be49-456acfc7eb11 |
| 10 | 764390120 | ANDA | Virtus Pharmaceuticals | 2013-10-09 | ACARBOSE | ORAL | TABLET | ANDA091343 | f87e7022-0129-4a01-9bd6-1205ae9c05cb |
relabeler product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 422910130 | ANDA | Avkare, Inc. | 2013-12-24 | ACARBOSE | ORAL | TABLET | 695430120 | ANDA091343 | 858c8cdd-ccf1-79c9-c245-7a852d280f20 | |
| 2 | 548685831 | Precose | NDA | Physicians Total Care, Inc. | 2007-11-19 | ACARBOSE | ORAL | TABLET | 504190863 | NDA020482 | e2158832-ad0b-4b9c-bbf0-1608a177bf85 |
| 3 | 548685945 | ANDA | Physicians Total Care, Inc. | 2008-10-03 | ACARBOSE | ORAL | TABLET | 000540140 | ANDA078470 | 26bca6c9-074d-480d-bd57-1e8fa9b3d05e |
acarbose 50 mg oral tablet
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 504190861 | Precose | NDA | Bayer Healthcare Pharmaceuticals Inc. | 2008-01-30 | ACARBOSE | ORAL | TABLET | NDA020482 | 29a6f213-bc93-4dbd-bab0-744722b6f0b8 |
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 000540141 | ANDA | Roxane Laboratories, Inc | 2008-05-07 | ACARBOSE | ORAL | TABLET | ANDA078470 | 352dd336-d3f9-4ac5-a000-91d3aef7aca3 |
| 2 | 001151151 | ANDA | Global Pharmaceuticals | 2009-05-14 | ACARBOSE | ORAL | TABLET | ANDA078441 | c41eaba7-49d5-43a4-9e4e-1ebc4da28982 |
| 3 | 003782821 | ANDA | Mylan Pharmaceuticals Inc. | 2011-01-06 | ACARBOSE | ORAL | TABLET | ANDA091053 | b56f1c19-b798-46d2-9ad1-73816ed86ef3 |
| 4 | 162520524 | ANDA | Actavis Pharma, Inc. | 2008-05-07 | ACARBOSE | ORAL | TABLET | ANDA077532 | 6c2db888-775c-4baf-a1b4-1cfa63b83357 |
| 5 | 231550148 | ANDA | Heritage Pharmaceuticals Inc. | 2012-07-30 | ACARBOSE | ORAL | TABLET | ANDA202271 | 29939129-7d09-4c22-bf3e-491a8a97f4c4 |
| 6 | 477810341 | NDA AUTHORIZED GENERIC | Alvogen, Inc. | 2008-01-30 | ACARBOSE | ORAL | TABLET | NDA020482 | e4148493-e3bd-4530-8fb6-cdb5197c010e |
| 7 | 695430121 | ANDA | Virtus Pharmaceuticals | 2015-02-01 | ACARBOSE | ORAL | TABLET | ANDA091343 | 6cd185e6-3205-484c-be49-456acfc7eb11 |
| 8 | 764390121 | ANDA | Virtus Pharmaceuticals | 2013-10-09 | ACARBOSE | ORAL | TABLET | ANDA091343 | f87e7022-0129-4a01-9bd6-1205ae9c05cb |
relabeler product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 422910131 | ANDA | Avkare, Inc. | 2013-12-24 | ACARBOSE | ORAL | TABLET | 695430121 | ANDA091343 | 858c8cdd-ccf1-79c9-c245-7a852d280f20 | |
| 2 | 433530908 | Precose | NDA | Aphena Pharma Solutions - Tennessee, Llc | 2008-01-30 | ACARBOSE | ORAL | TABLET | 504190861 | NDA020482 | c85bc02a-bf18-4690-84b8-2c256bce5f9f |
| 3 | 552890171 | ANDA | Pd-Rx Pharmaceuticals, Inc. | 2008-05-07 | ACARBOSE | ORAL | TABLET | 000540141 | ANDA078470 | bc76f641-efca-42b9-96ea-728b86ef54ec |
application(s)
| # | id | title | applicant | approved | approved drug |
|---|---|---|---|---|---|
| 1 | ANDA077532 | ACARBOSE | WATSON LABORATORIES INC | 2008-05-07 | ANDA077532_001, ANDA077532_002, ANDA077532_003 |
| 2 | ANDA078441 | ACARBOSE | IMPAX LABORATORIES INC | 2009-05-14 | ANDA078441_001, ANDA078441_002, ANDA078441_003 |
| 3 | ANDA078470 | ACARBOSE | ROXANE LABORATORIES INC | 2008-05-07 | ANDA078470_001, ANDA078470_002, ANDA078470_003 |
| 4 | ANDA090912 | ACARBOSE | STRIDES PHARMA GLOBAL PTE LTD | 2011-07-27 | ANDA090912_001, ANDA090912_002, ANDA090912_003 |
| 5 | ANDA091053 | ACARBOSE | MYLAN PHARMACEUTICALS INC | 2011-01-06 | ANDA091053_001, ANDA091053_002, ANDA091053_003 |
| 6 | ANDA091343 | ACARBOSE | VIRTUS PHARMACEUTICAL INC | 2013-10-17 | ANDA091343_001, ANDA091343_002, ANDA091343_003 |
| 7 | ANDA202271 | ACARBOSE | EMCURE PHARMACEUTICALS LTD | 2012-02-07 | ANDA202271_001, ANDA202271_002, ANDA202271_003 |
| 8 | NDA020482 | PRECOSE | BAYER HEALTHCARE PHARMACEUTICALS INC | 1995-09-06 | NDA020482_001, NDA020482_002, NDA020482_004 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|---|
| 1 | ANDA077532_001 | RX | ACARBOSE (25MG) | ORAL | TABLET | False | AB | 2008-05-07 | ACARBOSE |
| 2 | ANDA077532_002 | RX | ACARBOSE (50MG) | ORAL | TABLET | False | AB | 2008-05-07 | ACARBOSE |
| 3 | ANDA077532_003 | RX | ACARBOSE (100MG) | ORAL | TABLET | False | AB | 2008-05-07 | ACARBOSE |
| 4 | ANDA078441_001 | RX | ACARBOSE (25MG) | ORAL | TABLET | False | AB | 2009-05-14 | ACARBOSE |
| 5 | ANDA078441_002 | RX | ACARBOSE (50MG) | ORAL | TABLET | False | AB | 2009-05-14 | ACARBOSE |
| 6 | ANDA078441_003 | RX | ACARBOSE (100MG) | ORAL | TABLET | False | AB | 2009-05-14 | ACARBOSE |
| 7 | ANDA078470_001 | RX | ACARBOSE (25MG) | ORAL | TABLET | False | AB | 2008-05-07 | ACARBOSE |
| 8 | ANDA078470_002 | RX | ACARBOSE (50MG) | ORAL | TABLET | False | AB | 2008-05-07 | ACARBOSE |
| 9 | ANDA078470_003 | RX | ACARBOSE (100MG) | ORAL | TABLET | False | AB | 2008-05-07 | ACARBOSE |
| 10 | ANDA090912_001 | RX | ACARBOSE (25MG) | ORAL | TABLET | False | AB | 2011-07-27 | ACARBOSE |
| 11 | ANDA090912_002 | RX | ACARBOSE (50MG) | ORAL | TABLET | False | AB | 2011-07-27 | ACARBOSE |
| 12 | ANDA090912_003 | RX | ACARBOSE (100MG) | ORAL | TABLET | False | AB | 2011-07-27 | ACARBOSE |
| 13 | ANDA091053_001 | RX | ACARBOSE (25MG) | ORAL | TABLET | False | AB | 2011-01-06 | ACARBOSE |
| 14 | ANDA091053_002 | RX | ACARBOSE (50MG) | ORAL | TABLET | False | AB | 2011-01-06 | ACARBOSE |
| 15 | ANDA091053_003 | RX | ACARBOSE (100MG) | ORAL | TABLET | False | AB | 2011-01-06 | ACARBOSE |
| 16 | ANDA091343_001 | RX | ACARBOSE (25MG) | ORAL | TABLET | False | AB | 2013-10-17 | ACARBOSE |
| 17 | ANDA091343_002 | RX | ACARBOSE (50MG) | ORAL | TABLET | False | AB | 2013-10-17 | ACARBOSE |
| 18 | ANDA091343_003 | RX | ACARBOSE (100MG) | ORAL | TABLET | False | AB | 2013-10-17 | ACARBOSE |
| 19 | ANDA202271_001 | RX | ACARBOSE (25MG) | ORAL | TABLET | False | AB | 2012-02-07 | ACARBOSE |
| 20 | ANDA202271_002 | RX | ACARBOSE (50MG) | ORAL | TABLET | False | AB | 2012-02-07 | ACARBOSE |
| 21 | ANDA202271_003 | RX | ACARBOSE (100MG) | ORAL | TABLET | False | AB | 2012-02-07 | ACARBOSE |
| 22 | NDA020482_001 | RX | ACARBOSE (50MG) | ORAL | TABLET | False | AB | 1995-09-06 | PRECOSE |
| 23 | NDA020482_002 | RX | ACARBOSE (100MG) | ORAL | TABLET | False | AB | 1995-09-06 | PRECOSE |
| 24 | NDA020482_004 | RX | ACARBOSE (25MG) | ORAL | TABLET | True | AB | 1997-05-29 | PRECOSE |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 26bca6c9-074d-480d-bd57-1e8fa9b3d05e (view SPL) | Acarbose Tablets | prescription | Human Prescription | Physicians Total Care, Inc. | relabel, repack | 2009-10-12 | 1 | 548685945 |
| 2 | 29939129-7d09-4c22-bf3e-491a8a97f4c4 (view SPL) | prescription | Human Prescription | Heritage Pharmaceuticals Inc. | ANALYSIS, MANUFACTURE | 2013-10-23 | 12 | 231550147, 231550148, 231550149 | |
| 3 | 29a6f213-bc93-4dbd-bab0-744722b6f0b8 (view SPL) | PRECOSE (acarbose tablets) | prescription | Human Prescription | Bayer Healthcare Pharmaceuticals Inc. | MANUFACTURE | 2015-03-11 | 4 | 504190861, 504190862, 504190863 |
| 4 | 352dd336-d3f9-4ac5-a000-91d3aef7aca3 (view SPL) | prescription | Human Prescription | Roxane Laboratories, Inc | API MANUFACTURE, MANUFACTURE | 2015-04-27 | 6 | 000540140, 000540141, 000540142 | |
| 5 | 656769ee-e292-4950-83df-a38e6b1a9d6e (view SPL) | Acarbose Tablets | prescription | Human Prescription | Strides Arcolab Limited | Analysis, Manufacture, Pack | 2013-11-07 | 2 | 643800758 |
| 6 | 6c2db888-775c-4baf-a1b4-1cfa63b83357 (view SPL) | ACARBOSE TABLETS | prescription | Human Prescription | Actavis Pharma, Inc. | ANALYSIS, MANUFACTURE, PACK | 2014-09-01 | 8 | 162520523, 162520524, 162520525 |
| 7 | 6cd185e6-3205-484c-be49-456acfc7eb11 (view SPL) | Acarbose Tablets25 mg, 50 mg and 100 mgRx Only | prescription | Human Prescription | Virtus Pharmaceuticals | 2015-07-01 | 2 | 695430120, 695430121, 695430122 | |
| 8 | 858c8cdd-ccf1-79c9-c245-7a852d280f20 (view SPL) | Acarbose Tablets25 mg, 50 mg and 100 mgRx Only | prescription | Human Prescription | Avkare, Inc. | 2015-10-15 | 3 | 422910130, 422910131, 422910132 | |
| 9 | b56f1c19-b798-46d2-9ad1-73816ed86ef3 (view SPL) | prescription | Human Prescription | Mylan Pharmaceuticals Inc. | 2015-04-29 | 5 | 003782820, 003782821, 003782822 | ||
| 10 | bc76f641-efca-42b9-96ea-728b86ef54ec (view SPL) | Acarbose Tablets | prescription | Human Prescription | Pd-Rx Pharmaceuticals, Inc. | repack | 2011-04-18 | 3 | 552890171 |
| 11 | c41eaba7-49d5-43a4-9e4e-1ebc4da28982 (view SPL) | ACARBOSE TABLETS 25 mg, 50 mg, and 100 mg | prescription | Human Prescription | Global Pharmaceuticals | 2015-01-07 | 4 | 001151150, 001151151, 001151152 | |
| 12 | c85bc02a-bf18-4690-84b8-2c256bce5f9f (view SPL) | PRECOSE ( acarbose tablets) | prescription | Human Prescription | Aphena Pharma Solutions - Tennessee, Llc | Repack | 2014-05-29 | 1 | 433530908 |
| 13 | dbb04848-93e2-42ca-a709-6a396913507e (view SPL) | Acarbose Tablets | prescription | Human Prescription | Libertas Pharma, Inc. | 2013-01-05 | 1 | 518620210 | |
| 14 | e2158832-ad0b-4b9c-bbf0-1608a177bf85 (view SPL) | PRECOSE ( acarbose tablets) | prescription | Human Prescription | Physicians Total Care, Inc. | relabel, repack | 2012-05-23 | 1 | 548685831 |
| 15 | e4148493-e3bd-4530-8fb6-cdb5197c010e (view SPL) | Acarbose | prescription | Human Prescription | Alvogen, Inc. | MANUFACTURE | 2015-03-11 | 3 | 477810340, 477810341, 477810342 |
| 16 | f87e7022-0129-4a01-9bd6-1205ae9c05cb (view SPL) | Acarbose Tablets25 mg, 50 mg and 100 mgRx Only | prescription | Human Prescription | Virtus Pharmaceuticals | 2013-09-25 | 2 | 764390120, 764390121, 764390122 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII