Potassium Chloride / Sodium Chloride Injectable Solution
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Baxter Healthcare Corporation (2014-07-24)
- Oldest Current Product
- 1979-02-02
- License(s)
- NDA, ANDA
- RxNORM
- INJECTABLE SOLUTION\POTASSIUM CHLORIDE:SODIUM CHLORIDE
- FDAOB
- INJECTION\INJECTION\POTASSIUM CHLORIDE: SODIUM CHLORIDE\rdfq
- SPL Active
- INTRAVENOUS\INJECTION, SOLUTION\POTASSIUM CHLORIDE: SODIUM CHLORIDE
INTRAVENOUS\SOLUTION\POTASSIUM CHLORIDE: SODIUM CHLORIDE - SPL Moiety
- INTRAVENOUS\INJECTION, SOLUTION\CHLORIDE ION
INTRAVENOUS\INJECTION, SOLUTION\POTASSIUM CATION: SODIUM CATION
INTRAVENOUS\SOLUTION\POTASSIUM CATION: SODIUM CATION
product(s) by strength(s)
potassium chloride 0.02 meq/ml / sodium chloride 0.0769 meq/ml injectable solution
original product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 003380704 | NDA | Baxter Healthcare Corporation | 1979-02-02 | POTASSIUM CHLORIDE, SODIUM CHLORIDE | INTRAVENOUS | INJECTION, SOLUTION | NDA017648 | becc7410-0a25-49f5-b0c3-240078479dc8 |
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 004099257 | ANDA | Hospira, Inc. | 2008-09-10 | POTASSIUM CHLORIDE, SODIUM CHLORIDE | INTRAVENOUS | INJECTION, SOLUTION | ANDA078446 | 3a3343e4-b480-4454-e28b-9f3cba932948 |
potassium chloride 0.02 meq/ml / sodium chloride 0.154 meq/ml injectable solution
original product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 002647865 | NDA | B. Braun Medical Inc. | 1989-09-29 | POTASSIUM CHLORIDE, SODIUM CHLORIDE | INTRAVENOUS | SOLUTION | NDA019708 | ecc38772-246a-46c4-b42a-b9b81124f27f |
| 2 | 004097115 | NDA | Hospira, Inc. | 1988-10-17 | POTASSIUM CHLORIDE, SODIUM CHLORIDE | INTRAVENOUS | INJECTION, SOLUTION | NDA019686 | 78e70270-3864-423e-f89b-656822fa35df |
potassium chloride 0.04 meq/ml / sodium chloride 0.154 meq/ml injectable solution
original product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 003380695 | NDA | Baxter Healthcare Corporation | 1979-02-02 | POTASSIUM CHLORIDE, SODIUM CHLORIDE | INTRAVENOUS | INJECTION, SOLUTION | NDA017648 | becc7410-0a25-49f5-b0c3-240078479dc8 |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug |
|---|---|---|---|---|---|---|
| 1 | ANDA078446 | POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | HOSPIRA INC | 2008-09-10 | ANDA078446_001 | |
| 2 | NDA017648 | POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | BAXTER HEALTHCARE CORP | NDA017648_001, NDA017648_002, NDA017648_003, NDA017648_004, NDA017648_005 | ||
| 3 | NDA018722 | SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER | True | B BRAUN MEDICAL INC | 1982-11-09 | NDA018722_001, NDA018722_002, NDA018722_003, NDA018722_004 |
| 4 | NDA019686 | POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | HOSPIRA INC | 1988-10-17 | NDA019686_001, NDA019686_002 | |
| 5 | NDA019708 | POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | B BRAUN MEDICAL INC | 1989-09-29 | NDA019708_001, NDA019708_002, NDA019708_003, NDA019708_004, NDA019708_005, NDA019708_006 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | ANDA078446_001 | RX | SODIUM CHLORIDE (450MG/100ML), POTASSIUM CHLORIDE (149MG/100ML) | INJECTION | False | AP | 2008-09-10 | POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER |
| 2 | NDA017648_001 | RX | POTASSIUM CHLORIDE (150MG/100ML), SODIUM CHLORIDE (900MG/100ML) | INJECTION | False | AP | POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | |
| 3 | NDA017648_002 | RX | POTASSIUM CHLORIDE (300MG/100ML), SODIUM CHLORIDE (900MG/100ML) | INJECTION | False | AP | POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | |
| 4 | NDA017648_003 | RX | POTASSIUM CHLORIDE (224MG/100ML), SODIUM CHLORIDE (900MG/100ML) | INJECTION | False | POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | ||
| 5 | NDA017648_004 | discontinued | SODIUM CHLORIDE (900MG/100ML), POTASSIUM CHLORIDE (75MG/100ML) | INJECTION | False | POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | ||
| 6 | NDA017648_005 | RX | SODIUM CHLORIDE (450MG/100ML), POTASSIUM CHLORIDE (150MG/100ML) | INJECTION | True | AP | 2002-11-26 | POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER |
| 7 | NDA018722_001 | discontinued | SODIUM CHLORIDE (900MG/100ML), POTASSIUM CHLORIDE (75MG/100ML) | INJECTION | False | 1982-11-09 | SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER | |
| 8 | NDA018722_002 | discontinued | POTASSIUM CHLORIDE (150MG/100ML), SODIUM CHLORIDE (900MG/100ML) | INJECTION | False | 1982-11-09 | SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER | |
| 9 | NDA018722_003 | discontinued | SODIUM CHLORIDE (900MG/100ML), POTASSIUM CHLORIDE (220MG/100ML) | INJECTION | False | 1982-11-09 | SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER | |
| 10 | NDA018722_004 | discontinued | SODIUM CHLORIDE (900MG/100ML), POTASSIUM CHLORIDE (300MG/100ML) | INJECTION | False | 1982-11-09 | SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER | |
| 11 | NDA019686_001 | RX | POTASSIUM CHLORIDE (149MG/100ML), SODIUM CHLORIDE (900MG/100ML) | INJECTION | False | AP | 1988-10-17 | POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
| 12 | NDA019686_002 | RX | SODIUM CHLORIDE (900MG/100ML), POTASSIUM CHLORIDE (298MG/100ML) | INJECTION | False | AP | 1988-10-17 | POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
| 13 | NDA019708_001 | discontinued | SODIUM CHLORIDE (900MG/100ML), POTASSIUM CHLORIDE (37MG/100ML) | INJECTION | False | 1989-09-29 | POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | |
| 14 | NDA019708_002 | discontinued | POTASSIUM CHLORIDE (75MG/100ML), SODIUM CHLORIDE (900MG/100ML) | INJECTION | False | 1989-09-29 | POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | |
| 15 | NDA019708_003 | discontinued | SODIUM CHLORIDE (900MG/100ML), POTASSIUM CHLORIDE (110MG/100ML) | INJECTION | False | 1989-09-29 | POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | |
| 16 | NDA019708_004 | RX | SODIUM CHLORIDE (900MG/100ML), POTASSIUM CHLORIDE (150MG/100ML) | INJECTION | False | AP | 1989-09-29 | POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
| 17 | NDA019708_005 | discontinued | SODIUM CHLORIDE (900MG/100ML), POTASSIUM CHLORIDE (220MG/100ML) | INJECTION | False | 1989-09-29 | POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | |
| 18 | NDA019708_006 | discontinued | POTASSIUM CHLORIDE (300MG/100ML), SODIUM CHLORIDE (900MG/100ML) | INJECTION | False | 1989-09-29 | POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 3a3343e4-b480-4454-e28b-9f3cba932948 (view SPL) | Potassium Chloride in Sodium Chloride Injection, USP | prescription | Human Prescription | Hospira, Inc. | 2013-12-02 | 12 | 004099257 | |
| 2 | 78e70270-3864-423e-f89b-656822fa35df (view SPL) | INTRAVENOUS SOLUTIONS with POTASSIUM CHLORIDE | prescription | Human Prescription | Hospira, Inc. | 2012-08-13 | 12 | 004097115, 004097116 | |
| 3 | becc7410-0a25-49f5-b0c3-240078479dc8 (view SPL) | Potassium Chloride in Sodium Chloride Injection, USP in Plastic Container VIAFLEX Plus Container | prescription | Human Prescription | Baxter Healthcare Corporation | ANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE | 2014-07-24 | 5 | 003380695, 003380704, 003380691 |
| 4 | ecc38772-246a-46c4-b42a-b9b81124f27f (view SPL) | Potassium Chloride in 0.9% Sodium Chloride Injections | prescription | Human Prescription | B. Braun Medical Inc. | 2011-08-17 | 7 | 002647865, 002647885 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII