cefdinir Oral Capsule
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Sandoz Inc (2012-04-10)
- Oldest Current Product
- 2007-04-06
- License(s)
- ANDA
- RxNORM
- ORAL CAPSULE\CEFDINIR
- FDAOB
- ORAL\CAPSULE\CEFDINIR
- SPL Active
- ORAL\CAPSULE\CEFDINIR
ORAL\CAPSULE\CEFDINIR MONOHYDRATE - SPL Moiety
- ORAL\CAPSULE\CEFDINIR
product(s) by strength(s)
cefdinir 300 mg oral capsule
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 000933160 | ANDA | Teva Pharmaceuticals Usa Inc | 2007-05-09 | CEFDINIR | ORAL | CAPSULE | ANDA065368 | de3441e3-7fd2-4d29-a8b7-0f9b66e35c9c |
| 2 | 007812176 | ANDA | Sandoz Inc | 2007-04-06 | CEFDINIR | ORAL | CAPSULE | ANDA065330 | 38f6adf7-e26c-4764-8ec9-360813874dd4 |
| 3 | 167140391 | ANDA | Northstar Rx Llc | 2008-01-07 | CEFDINIR | ORAL | CAPSULE | ANDA065434 | 831f04e4-4566-49f8-9552-2378307a10c8 |
| 4 | 420430250 | ANDA | Orchidpharma Inc | 2014-07-04 | CEFDINIR MONOHYDRATE | ORAL | CAPSULE | ANDA065418 | 417d5645-ea57-4a07-a21d-31a7132721cd |
| 5 | 572370099 | ANDA | Citron Pharma Llc | 2008-01-07 | CEFDINIR | ORAL | CAPSULE | ANDA065434 | a5594006-8e37-459e-8e85-7e2a83d7a57e |
| 6 | 658620177 | ANDA | Aurobindo Pharma Limited | 2008-01-07 | CEFDINIR | ORAL | CAPSULE | ANDA065434 | df26edb0-9bd6-449c-a187-0be0c9e2600c |
| 7 | 672530011 | ANDA | Dava Pharmaceuticals, Inc. | 2014-05-01 | CEFDINIR | ORAL | CAPSULE | ANDA065330 | befe82b9-e822-4917-9774-b4cbd0c66a1e |
| 8 | 680010150 | ANDA | Bluepoint Laboratories | 2014-02-07 | CEFDINIR | ORAL | CAPSULE | ANDA065264 | a056eb8b-04e8-42fb-a4ff-42f017a113cb |
| 9 | 681800711 | ANDA | Lupin Pharmaceuticals, Inc. | 2007-05-01 | CEFDINIR | ORAL | CAPSULE | ANDA065264 | cb7366ce-1778-451f-aba5-65cf73c9b87a |
relabeler product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 105440194 | ANDA | Blenheim Pharmacal, Inc. | 2013-11-15 | CEFDINIR | ORAL | CAPSULE | 658620177 | ANDA065434 | 1181a59e-a433-20d0-e054-00144ff88e88 |
| 2 | 216950620 | ANDA | Rebel Distributors Corp | 2008-01-07 | CEFDINIR | ORAL | CAPSULE | 658620177 | ANDA065434 | a84712bf-221d-4366-9cf0-b8c19428c276 |
| 3 | 422540177 | ANDA | Rebel Distributors Corp | 2011-01-14 | CEFDINIR | ORAL | CAPSULE | 000933160 | ANDA065368 | f910ec1a-3896-45b9-b8b2-df50a50064a1 |
| 4 | 430630466 | ANDA | Pd-Rx Pharmaceuticals, Inc. | 2007-05-01 | CEFDINIR | ORAL | CAPSULE | 681800711 | ANDA065264 | 6f76b0f7-2b50-4d14-8bec-010597ae2880 |
| 5 | 430630597 | ANDA | Pd-Rx Pharmaceuticals, Inc. | 2014-07-04 | CEFDINIR MONOHYDRATE | ORAL | CAPSULE | 420430250 | ANDA065418 | 77e061e8-d3e2-4955-9f65-59510b5afc70 |
| 6 | 430630603 | ANDA | Pd-Rx Pharmaceuticals, Inc. | 2014-07-04 | CEFDINIR MONOHYDRATE | ORAL | CAPSULE | 420430250 | ANDA065418 | eb3b3440-95f4-450a-af9c-a87aca480bad |
| 7 | 516550019 | ANDA | Northwind Pharmaceuticals, Llc | 2015-02-10 | CEFDINIR | ORAL | CAPSULE | 672530011 | ANDA065330 | c36c0d83-583b-4448-97a3-00169fcbdf75 |
| 8 | 516550214 | ANDA | Northwind Pharmaceuticals, Llc | 2014-09-17 | CEFDINIR | ORAL | CAPSULE | 000933160 | ANDA065368 | 145e4a41-286e-4033-97c4-92d674d7bb89 |
| 9 | 529590134 | ANDA | H.J. Harkins Company, Inc. | 2008-08-23 | CEFDINIR | ORAL | CAPSULE | 658620177 | ANDA065434 | a3262279-1f9e-401b-9b02-6da3ef374b46 |
| 10 | 545695921 | ANDA | A-S Medication Solutions Llc | 2007-05-01 | CEFDINIR | ORAL | CAPSULE | 681800711 | ANDA065264 | c2d25379-bec7-4583-a8bc-8c03cdb893ed |
| 11 | 548685767 | ANDA | Physicians Total Care, Inc. | 2007-05-08 | CEFDINIR | ORAL | CAPSULE | 658620177 | ANDA065434 | a78a68a4-5425-43c4-81cc-7733b72445b8 |
| 12 | 552890081 | ANDA | Pd-Rx Pharmaceuticals, Inc. | 2011-01-14 | CEFDINIR | ORAL | CAPSULE | 000933160 | ANDA065368 | c3ca8720-8e27-47ed-9829-a42ae9eb885d |
| 13 | 672960469 | ANDA | Redpharm Drug Inc. | 2007-05-01 | CEFDINIR | ORAL | CAPSULE | 681800711 | ANDA065264 | bcf04f49-8d0b-4563-9d0f-93939cdf6a6c |
| 14 | 687889760 | ANDA | Preferred Pharmaceuticals, Inc. | 2015-08-20 | CEFDINIR MONOHYDRATE | ORAL | CAPSULE | 420430250 | ANDA065418 | 1165564d-025e-460d-a1bd-1ca5300ae3fe |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug |
|---|---|---|---|---|---|---|
| 1 | ANDA065264 | CEFDINIR | LUPIN LTD | 2006-05-19 | ANDA065264_001 | |
| 2 | ANDA065330 | CEFDINIR | SANDOZ INC | 2007-04-06 | ANDA065330_001 | |
| 3 | ANDA065368 | CEFDINIR | TEVA PHARMACEUTICALS USA | 2007-05-09 | ANDA065368_001 | |
| 4 | ANDA065418 | CEFDINIR | ORCHID HEALTHCARE | 2007-07-18 | ANDA065418_001 | |
| 5 | ANDA065434 | CEFDINIR | AUROBINDO PHARMA LTD | 2008-01-07 | ANDA065434_001 | |
| 6 | NDA050739 | OMNICEF | True | ABBVIE INC | 1997-12-04 | NDA050739_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|---|
| 1 | ANDA065264_001 | RX | CEFDINIR (300MG) | ORAL | CAPSULE | False | AB | 2006-05-19 | CEFDINIR |
| 2 | ANDA065330_001 | RX | CEFDINIR (300MG) | ORAL | CAPSULE | True | AB | 2007-04-06 | CEFDINIR |
| 3 | ANDA065368_001 | RX | CEFDINIR (300MG) | ORAL | CAPSULE | False | AB | 2007-05-09 | CEFDINIR |
| 4 | ANDA065418_001 | RX | CEFDINIR (300MG) | ORAL | CAPSULE | False | AB | 2007-07-18 | CEFDINIR |
| 5 | ANDA065434_001 | RX | CEFDINIR (300MG) | ORAL | CAPSULE | False | AB | 2008-01-07 | CEFDINIR |
| 6 | NDA050739_001 | discontinued | CEFDINIR (300MG) | ORAL | CAPSULE | False | 1997-12-04 | OMNICEF |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 1165564d-025e-460d-a1bd-1ca5300ae3fe (view SPL) | Cefdinir Capsules, USP | prescription | Human Prescription | Preferred Pharmaceuticals, Inc. | REPACK | 2015-08-20 | 1 | 687889760 |
| 2 | 1181a59e-a433-20d0-e054-00144ff88e88 (view SPL) | Cefdinir Capsules, USP Rx Only | prescription | Human Prescription | Blenheim Pharmacal, Inc. | repack | 2015-03-17 | 1 | 105440194 |
| 3 | 145e4a41-286e-4033-97c4-92d674d7bb89 (view SPL) | Cefdinir | prescription | Human Prescription | Northwind Pharmaceuticals, Llc | repack | 2014-09-23 | 1 | 516550214 |
| 4 | 38f6adf7-e26c-4764-8ec9-360813874dd4 (view SPL) | Cefdinir Capsules | prescription | Human Prescription | Sandoz Inc | 2012-04-10 | 11 | 007812176 | |
| 5 | 417d5645-ea57-4a07-a21d-31a7132721cd (view SPL) | Cefdinir Capsules, USP | prescription | Human Prescription | Orchidpharma Inc | analysis, label, manufacture, pack | 2014-07-25 | 2 | 420430250 |
| 6 | 6f76b0f7-2b50-4d14-8bec-010597ae2880 (view SPL) | CEFDINIR CAPSULES USP | prescription | Human Prescription | Pd-Rx Pharmaceuticals, Inc. | repack | 2011-04-01 | 3 | 430630466 |
| 7 | 77e061e8-d3e2-4955-9f65-59510b5afc70 (view SPL) | Cefdinir Capsules, USP | prescription | Human Prescription | Pd-Rx Pharmaceuticals, Inc. | repack | 2014-07-25 | 3 | 430630597 |
| 8 | 831f04e4-4566-49f8-9552-2378307a10c8 (view SPL) | Cefdinir Capsules, USP | prescription | Human Prescription | Northstar Rx Llc | ANALYSIS, API MANUFACTURE, MANUFACTURE | 2013-02-08 | 1 | 167140391 |
| 9 | a056eb8b-04e8-42fb-a4ff-42f017a113cb (view SPL) | CEFDINIR CAPSULES USP | prescription | Human Prescription | Bluepoint Laboratories | MANUFACTURE | 2015-05-13 | 2 | 680010150 |
| 10 | a3262279-1f9e-401b-9b02-6da3ef374b46 (view SPL) | Cefdinir Capsules | prescription | Human Prescription | H.J. Harkins Company, Inc. | MANUFACTURE | 2011-08-23 | 1 | 529590134 |
| 11 | a5594006-8e37-459e-8e85-7e2a83d7a57e (view SPL) | Cefdinir Capsules, USPRx Only | prescription | Human Prescription | Citron Pharma Llc | ANALYSIS, API MANUFACTURE, MANUFACTURE | 2014-08-07 | 1 | 572370099 |
| 12 | a78a68a4-5425-43c4-81cc-7733b72445b8 (view SPL) | Cefdinir Capsules | prescription | Human Prescription | Physicians Total Care, Inc. | relabel, repack | 2010-12-02 | 3 | 548685767 |
| 13 | a84712bf-221d-4366-9cf0-b8c19428c276 (view SPL) | Cefdinir Capsules | prescription | Human Prescription | Rebel Distributors Corp | RELABEL, REPACK | 2011-01-17 | 1 | 216950620 |
| 14 | bcf04f49-8d0b-4563-9d0f-93939cdf6a6c (view SPL) | Cednifir Capsules | prescription | Human Prescription | Redpharm Drug Inc. | manufacture | 2011-07-06 | 2 | 672960469 |
| 15 | befe82b9-e822-4917-9774-b4cbd0c66a1e (view SPL) | CEFDINIR CAPSULES | prescription | Human Prescription | Dava Pharmaceuticals, Inc. | 2014-02-12 | 10 | 672530011 | |
| 16 | c2d25379-bec7-4583-a8bc-8c03cdb893ed (view SPL) | CEFDINIR CAPSULES USP | prescription | Human Prescription | A-S Medication Solutions Llc | repack | 2013-06-22 | 1 | 545695921 |
| 17 | c36c0d83-583b-4448-97a3-00169fcbdf75 (view SPL) | CEFDINIR | prescription | Human Prescription | Northwind Pharmaceuticals, Llc | repack | 2015-03-25 | 1 | 516550019 |
| 18 | c3ca8720-8e27-47ed-9829-a42ae9eb885d (view SPL) | CEFDINIR CAPSULES3160Rx only | prescription | Human Prescription | Pd-Rx Pharmaceuticals, Inc. | repack | 2011-01-14 | 3 | 552890081 |
| 19 | cb7366ce-1778-451f-aba5-65cf73c9b87a (view SPL) | CEFDINIR CAPSULES USP | prescription | Human Prescription | Lupin Pharmaceuticals, Inc. | 2011-04-01 | 1 | 681800711 | |
| 20 | de3441e3-7fd2-4d29-a8b7-0f9b66e35c9c (view SPL) | CEFDINIR CAPSULES USP3160Rx only | prescription | Human Prescription | Teva Pharmaceuticals Usa Inc | 2014-10-02 | 6 | 000933160 | |
| 21 | df26edb0-9bd6-449c-a187-0be0c9e2600c (view SPL) | Cefdinir Capsules, USPRx Only | prescription | Human Prescription | Aurobindo Pharma Limited | ANALYSIS, API MANUFACTURE, MANUFACTURE | 2014-09-05 | 9 | 658620177 |
| 22 | eb3b3440-95f4-450a-af9c-a87aca480bad (view SPL) | Cefdinir Capsules, USP | prescription | Human Prescription | Pd-Rx Pharmaceuticals, Inc. | repack | 2014-07-25 | 3 | 430630603 |
| 23 | f910ec1a-3896-45b9-b8b2-df50a50064a1 (view SPL) | CEFDINIR CAPSULES3160Rx only | prescription | Human Prescription | Rebel Distributors Corp | RELABEL, REPACK | 2012-03-20 | 1 | 422540177 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII