Cefuroxime Injection
- Brand(s)
- Zinacef
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Covis Pharmaceuticals, Inc. (2014-10-09)
- Oldest Current Product
- 2004-01-09
- License(s)
- NDA, ANDA
- RxNORM
- INJECTION\CEFUROXIME
- FDAOB
- INJECTION\INJECTION\CEFUROXIME SODIUM\rdfq
INTRAMUSCULAR, INTRAVENOUS\INJECTION\CEFUROXIME SODIUM\rdfq
INTRAVENOUS\INJECTION\CEFUROXIME SODIUM - SPL Active
- INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\CEFUROXIME
INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\CEFUROXIME SODIUM
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\CEFUROXIME
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\CEFUROXIME SODIUM - SPL Moiety
- INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\CEFUROXIME
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\CEFUROXIME
product(s) by strength(s)
cefuroxime 1500 mg injection
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 249870354 | Zinacef | NDA | Covis Pharmaceuticals, Inc. | 2013-01-15 | CEFUROXIME SODIUM | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | NDA050558 | 5aa67341-d2fd-493d-ba58-0a0a573fb64a |
| 2 | 249870437 | Zinacef | NDA | Covis Pharmaceuticals, Inc. | 2013-01-15 | CEFUROXIME SODIUM | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | NDA050558 | 5aa67341-d2fd-493d-ba58-0a0a573fb64a |
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 001439567 | ANDA | West-Ward Pharmaceutical Corp | 2004-01-09 | CEFUROXIME SODIUM | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA065048 | 19902965-d2d6-433f-982d-0095014df4e8 |
| 2 | 001439977 | ANDA | West-Ward Pharmaceutical Corp | 2004-01-09 | CEFUROXIME SODIUM | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA065048 | 703cc338-c0b6-4a02-b8db-c27aeff181df |
| 3 | 004090802 | ANDA | Hospira, Inc. | 2009-04-27 | CEFUROXIME SODIUM | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA065503 | 1fd2babd-4737-45ad-9464-a7479a3816d9 |
| 4 | 250210119 | ANDA | Sagent Pharmaceuticals | 2008-05-01 | CEFUROXIME SODIUM | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA065048 | 0a145288-733a-4966-b7ae-dc96eb103d8c |
| 5 | 445670711 | ANDA | Wg Critical Care, Llc | 2012-10-04 | CEFUROXIME SODIUM | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA064125 | f4797359-d4a0-4967-86d3-d348518b3fe4 |
| 6 | 445670722 | ANDA | Wg Critical Care, Llc | 2012-10-04 | CEFUROXIME SODIUM | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA064125 | f4797359-d4a0-4967-86d3-d348518b3fe4 |
| 7 | 633230353 | ANDA | App Pharmaceuticals, Llc | 2011-05-24 | CEFUROXIME | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA064125 | 68e22782-f3a6-4e2c-8612-3f1608547919 |
cefuroxime 750 mg injection
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 249870352 | Zinacef | NDA | Covis Pharmaceuticals, Inc. | 2013-01-15 | CEFUROXIME SODIUM | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | NDA050558 | 5aa67341-d2fd-493d-ba58-0a0a573fb64a |
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 001439568 | ANDA | West-Ward Pharmaceutical Corp | 2004-01-09 | CEFUROXIME SODIUM | INTRAMUSCULAR | INJECTION, POWDER, FOR SOLUTION | ANDA065048 | 19902965-d2d6-433f-982d-0095014df4e8 |
| 2 | 001439979 | ANDA | West-Ward Pharmaceutical Corp | 2004-01-09 | CEFUROXIME SODIUM | INTRAMUSCULAR | INJECTION, POWDER, FOR SOLUTION | ANDA065048 | 703cc338-c0b6-4a02-b8db-c27aeff181df |
| 3 | 250210118 | ANDA | Sagent Pharmaceuticals | 2008-05-01 | CEFUROXIME SODIUM | INTRAMUSCULAR | INJECTION, POWDER, FOR SOLUTION | ANDA065048 | 0a145288-733a-4966-b7ae-dc96eb103d8c |
| 4 | 445670710 | ANDA | Wg Critical Care, Llc | 2012-10-04 | CEFUROXIME SODIUM | INTRAMUSCULAR | INJECTION, POWDER, FOR SOLUTION | ANDA064125 | f4797359-d4a0-4967-86d3-d348518b3fe4 |
| 5 | 445670720 | ANDA | Wg Critical Care, Llc | 2012-10-04 | CEFUROXIME SODIUM | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA064125 | f4797359-d4a0-4967-86d3-d348518b3fe4 |
| 6 | 633230352 | ANDA | App Pharmaceuticals, Llc | 2011-05-24 | CEFUROXIME | INTRAMUSCULAR | INJECTION, POWDER, FOR SOLUTION | ANDA064125 | 68e22782-f3a6-4e2c-8612-3f1608547919 |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug | in other drug docs |
|---|---|---|---|---|---|---|---|
| 1 | ANDA062590 | KEFUROX IN PLASTIC CONTAINER | True | ELI LILLY AND CO | 1986-01-10 | ANDA062590_001, ANDA062590_002 | Cefuroxime Injectable Solution |
| 2 | ANDA062591 | KEFUROX | True | ACS DOBFAR SPA | 1986-01-10 | ANDA062591_001, ANDA062591_002, ANDA062591_003 | Cefuroxime Injectable Solution |
| 3 | ANDA062592 | KEFUROX | True | ELI LILLY AND CO | 1986-01-10 | ANDA062592_001, ANDA062592_002 | Cefuroxime Injectable Solution |
| 4 | ANDA064035 | CEFUROXIME SODIUM | True | WATSON LABORATORIES INC | 1993-02-26 | ANDA064035_001, ANDA064035_002 | Cefuroxime Injectable Solution |
| 5 | ANDA064036 | CEFUROXIME SODIUM | True | WATSON LABORATORIES INC | 1993-02-26 | ANDA064036_001 | Cefuroxime Injectable Solution |
| 6 | ANDA064124 | CEFUROXIME SODIUM | FACTA FARMACEUTICI SPA | 1997-05-30 | ANDA064124_001 | Cefuroxime Injectable Solution | |
| 7 | ANDA064125 | CEFUROXIME SODIUM | FACTA FARMACEUTICI SPA | 1997-05-30 | ANDA064125_001, ANDA064125_002 | Cefuroxime Injectable Solution | |
| 8 | ANDA064191 | CEFUROXIME SODIUM | True | TEVA PHARMACEUTICALS USA | 1998-04-16 | ANDA064191_001 | Cefuroxime Injectable Solution |
| 9 | ANDA064192 | CEFUROXIME SODIUM | True | TEVA PHARMACEUTICALS USA | 1998-04-16 | ANDA064192_001, ANDA064192_002 | Cefuroxime Injectable Solution |
| 10 | ANDA065001 | CEFUROXIME SODIUM | True | FRESENIUS KABI USA LLC | 2001-05-30 | ANDA065001_001, ANDA065001_002 | Cefuroxime Injectable Solution |
| 11 | ANDA065002 | CEFUROXIME SODIUM | True | FRESENIUS KABI USA LLC | 1998-09-28 | ANDA065002_001 | Cefuroxime Injectable Solution |
| 12 | ANDA065046 | CEFUROXIME SODIUM | HIKMA FARMACEUTICA PORTUGAL LDA | 2004-01-09 | ANDA065046_001 | Cefuroxime Injectable Solution | |
| 13 | ANDA065048 | CEFUROXIME SODIUM | HIKMA FARMACEUTICA PORTUGAL LDA | 2004-01-09 | ANDA065048_001, ANDA065048_002 | Cefuroxime Injectable Solution | |
| 14 | ANDA065251 | CEFUROXIME SODIUM IN PLASTIC CONTAINER | True | SAMSON MEDICAL TECHNOLOGIES LLC | 2009-12-30 | ANDA065251_001, ANDA065251_002 | Cefuroxime Injectable Solution |
| 15 | ANDA065483 | CEFUROXIME SODIUM | HOSPIRA INC | 2008-10-15 | ANDA065483_001, ANDA065483_002 | Cefuroxime Injectable Solution | |
| 16 | ANDA065484 | CEFUROXIME SODIUM | HOSPIRA INC | 2008-10-15 | ANDA065484_001 | Cefuroxime Injectable Solution | |
| 17 | ANDA065503 | CEFUROXIME SODIUM | HOSPIRA INC | 2008-10-15 | ANDA065503_001 | Cefuroxime Injectable Solution | |
| 18 | NDA050558 | ZINACEF | CONCORDIA PHARMACEUTICALS INC | 1983-10-19 | NDA050558_002, NDA050558_003, NDA050558_004 | Cefuroxime Injectable Solution | |
| 19 | NDA050643 | ZINACEF IN PLASTIC CONTAINER | CONCORDIA PHARMACEUTICALS INC | 1989-04-28 | NDA050643_001, NDA050643_002 | Cefuroxime Injectable Solution | |
| 20 | NDA050780 | CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER | B BRAUN MEDICAL INC | 2001-02-21 | NDA050780_001, NDA050780_002 | Cefuroxime Injectable Solution |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|---|
| 1 | ANDA062590_001 | discontinued | CEFUROXIME SODIUM (EQ 750MG BASE/VIAL) | INTRAVENOUS | INJECTION | False | 1986-01-10 | KEFUROX IN PLASTIC CONTAINER | |
| 2 | ANDA062590_002 | discontinued | CEFUROXIME SODIUM (EQ 1.5GM BASE/VIAL) | INJECTION | False | 1986-01-10 | KEFUROX IN PLASTIC CONTAINER | ||
| 3 | ANDA062591_001 | discontinued | CEFUROXIME SODIUM (EQ 750MG BASE/VIAL) | INJECTION | False | 1986-01-10 | KEFUROX | ||
| 4 | ANDA062591_002 | discontinued | CEFUROXIME SODIUM (EQ 1.5GM BASE/VIAL) | INJECTION | False | 1986-01-10 | KEFUROX | ||
| 5 | ANDA062591_003 | discontinued | CEFUROXIME SODIUM (EQ 7.5GM BASE/VIAL) | INJECTION | False | 1987-12-17 | KEFUROX | ||
| 6 | ANDA062592_001 | discontinued | CEFUROXIME SODIUM (EQ 750MG BASE/VIAL) | INTRAVENOUS | INJECTION | False | 1986-01-10 | KEFUROX | |
| 7 | ANDA062592_002 | discontinued | CEFUROXIME SODIUM (EQ 1.5GM BASE/VIAL) | INJECTION | False | 1986-01-10 | KEFUROX | ||
| 8 | ANDA064035_001 | discontinued | CEFUROXIME SODIUM (EQ 750MG BASE/VIAL) | INJECTION | False | 1993-02-26 | CEFUROXIME SODIUM | ||
| 9 | ANDA064035_002 | discontinued | CEFUROXIME SODIUM (EQ 1.5GM BASE/VIAL) | INJECTION | False | 1993-02-26 | CEFUROXIME SODIUM | ||
| 10 | ANDA064036_001 | discontinued | CEFUROXIME SODIUM (EQ 7.5GM BASE/VIAL) | INJECTION | False | 1993-02-26 | CEFUROXIME SODIUM | ||
| 11 | ANDA064124_001 | RX | CEFUROXIME SODIUM (EQ 7.5GM BASE/VIAL) | INJECTION | False | AP | 1997-05-30 | CEFUROXIME SODIUM | |
| 12 | ANDA064125_001 | RX | CEFUROXIME SODIUM (EQ 750MG BASE/VIAL) | INJECTION | False | AB | 1997-05-30 | CEFUROXIME SODIUM | |
| 13 | ANDA064125_002 | RX | CEFUROXIME SODIUM (EQ 1.5GM BASE/VIAL) | INJECTION | False | AP | 1997-05-30 | CEFUROXIME SODIUM | |
| 14 | ANDA064191_001 | discontinued | CEFUROXIME SODIUM (EQ 7.5GM BASE/VIAL) | INJECTION | False | 1998-04-16 | CEFUROXIME SODIUM | ||
| 15 | ANDA064192_001 | discontinued | CEFUROXIME SODIUM (EQ 1.5GM BASE/VIAL) | INJECTION | False | 1998-04-16 | CEFUROXIME SODIUM | ||
| 16 | ANDA064192_002 | discontinued | CEFUROXIME SODIUM (EQ 750MG BASE/VIAL) | INJECTION | False | 1998-04-16 | CEFUROXIME SODIUM | ||
| 17 | ANDA065001_001 | discontinued | CEFUROXIME SODIUM (EQ 750MG BASE/VIAL) | INJECTION | False | 2001-05-30 | CEFUROXIME SODIUM | ||
| 18 | ANDA065001_002 | discontinued | CEFUROXIME SODIUM (EQ 1.5GM BASE/VIAL) | INJECTION | False | 2001-05-30 | CEFUROXIME SODIUM | ||
| 19 | ANDA065002_001 | discontinued | CEFUROXIME SODIUM (EQ 7.5GM BASE/VIAL) | INJECTION | False | 1998-09-28 | CEFUROXIME SODIUM | ||
| 20 | ANDA065046_001 | RX | CEFUROXIME SODIUM (EQ 7.5GM BASE/VIAL) | INJECTION | False | AP | 2004-01-09 | CEFUROXIME SODIUM | |
| 21 | ANDA065048_001 | RX | CEFUROXIME SODIUM (EQ 750MG BASE/VIAL) | INJECTION | False | AB | 2004-01-09 | CEFUROXIME SODIUM | |
| 22 | ANDA065048_002 | RX | CEFUROXIME SODIUM (EQ 1.5GM BASE/VIAL) | INJECTION | False | AP | 2004-01-09 | CEFUROXIME SODIUM | |
| 23 | ANDA065251_001 | discontinued | CEFUROXIME SODIUM (EQ 75GM BASE/VIAL) | INJECTION | False | 2009-12-30 | CEFUROXIME SODIUM IN PLASTIC CONTAINER | ||
| 24 | ANDA065251_002 | discontinued | CEFUROXIME SODIUM (EQ 225GM BASE/VIAL) | INJECTION | False | 2009-12-30 | CEFUROXIME SODIUM IN PLASTIC CONTAINER | ||
| 25 | ANDA065483_001 | RX | CEFUROXIME SODIUM (EQ 750MG BASE/VIAL) | INJECTION | False | AP | 2008-10-15 | CEFUROXIME SODIUM | |
| 26 | ANDA065483_002 | RX | CEFUROXIME SODIUM (EQ 1.5GM BASE/VIAL) | INJECTION | False | AP | 2008-10-15 | CEFUROXIME SODIUM | |
| 27 | ANDA065484_001 | RX | CEFUROXIME SODIUM (EQ 7.5GM BASE/VIAL) | INJECTION | False | AP | 2008-10-15 | CEFUROXIME SODIUM | |
| 28 | ANDA065503_001 | RX | CEFUROXIME SODIUM (EQ 1.5GM BASE/VIAL) | INJECTION | False | AP | 2008-10-15 | CEFUROXIME SODIUM | |
| 29 | NDA050558_002 | RX | CEFUROXIME SODIUM (EQ 750MG BASE/VIAL) | INJECTION | True | AB | 1983-10-19 | ZINACEF | |
| 30 | NDA050558_003 | RX | CEFUROXIME SODIUM (EQ 1.5GM BASE/VIAL) | INJECTION | True | AP | 1983-10-19 | ZINACEF | |
| 31 | NDA050558_004 | RX | CEFUROXIME SODIUM (EQ 7.5GM BASE/VIAL) | INJECTION | True | AP | 1986-10-23 | ZINACEF | |
| 32 | NDA050643_001 | discontinued | CEFUROXIME SODIUM (EQ 15MG BASE/ML) | INJECTION | False | 1989-04-28 | ZINACEF IN PLASTIC CONTAINER | ||
| 33 | NDA050643_002 | RX | CEFUROXIME SODIUM (EQ 30MG BASE/ML) | INJECTION | True | 1989-04-28 | ZINACEF IN PLASTIC CONTAINER | ||
| 34 | NDA050780_001 | RX | CEFUROXIME SODIUM (EQ 750MG BASE/VIAL) | INJECTION | True | AP | 2001-02-21 | CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER | |
| 35 | NDA050780_002 | RX | CEFUROXIME SODIUM (EQ 1.5GM BASE/VIAL) | INJECTION | True | AP | 2001-02-21 | CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) | in other drug docs |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 0a145288-733a-4966-b7ae-dc96eb103d8c (view SPL) | CEFUROXIME FOR INJECTION, USP | prescription | Human Prescription | Sagent Pharmaceuticals | 2011-10-21 | 3 | 250210118, 250210119 | ||
| 2 | 19902965-d2d6-433f-982d-0095014df4e8 (view SPL) | CEFUROXIME FOR INJECTION, USP | prescription | Human Prescription | West-Ward Pharmaceutical Corp | ANALYSIS, LABEL, MANUFACTURE, PACK | 2015-03-18 | 1 | 001439567, 001439568 | |
| 3 | 1fd2babd-4737-45ad-9464-a7479a3816d9 (view SPL) | CEFUROXIME FOR INJECTION, USP | prescription | Human Prescription | Hospira, Inc. | 2015-08-31 | 5 | 004090802 | ||
| 4 | 5aa67341-d2fd-493d-ba58-0a0a573fb64a (view SPL) | ZINACEF (cefuroxime for injection) ZINACEF (cefuroxime injection) | prescription | Human Prescription | Covis Pharmaceuticals, Inc. | 2014-10-09 | 7 | 249870352, 249870354, 249870437, 249870400, 249870425, 249870436 | Cefuroxime Injectable Solution | |
| 5 | 68e22782-f3a6-4e2c-8612-3f1608547919 (view SPL) | Cefuroxime for Injection, USP | prescription | Human Prescription | App Pharmaceuticals, Llc | MANUFACTURE | 2011-05-24 | 2 | 633230352, 633230353 | |
| 6 | 703cc338-c0b6-4a02-b8db-c27aeff181df (view SPL) | CEFUROXIME FOR INJECTION, USP | prescription | Human Prescription | West-Ward Pharmaceutical Corp | ANALYSIS, LABEL, MANUFACTURE, PACK | 2015-03-18 | 2 | 001439977, 001439979 | |
| 7 | f4797359-d4a0-4967-86d3-d348518b3fe4 (view SPL) | Cefuroxime for Injection, USP | prescription | Human Prescription | Wg Critical Care, Llc | MANUFACTURE | 2012-10-04 | 9 | 445670710, 445670711, 445670720, 445670722 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII