Phenylephrine Injection
- Brand(s)
- Neo-Synephrine
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- West-Ward Pharmaceuticals Corp. (2014-06-03)
- Oldest Current Product
- 1990-09-30
- License(s)
- NDA, UNAPPROVED DRUG OTHER MARKETING CATEGORY
- RxNORM
- INJECTION\PHENYLEPHRINE
- FDAOB
- IV (INFUSION)\SOLUTION\PHENYLEPHRINE HYDROCHLORIDE\rdfq
- SPL Active
- INTRAMUSCULAR\INJECTION, SOLUTION\PHENYLEPHRINE HYDROCHLORIDE
INTRAMUSCULAR\INJECTION\PHENYLEPHRINE HYDROCHLORIDE
INTRAVENOUS\INJECTION\PHENYLEPHRINE HYDROCHLORIDE - SPL Moiety
- INTRAMUSCULAR\INJECTION, SOLUTION\PHENYLEPHRINE
INTRAMUSCULAR\INJECTION\PHENYLEPHRINE
INTRAVENOUS\INJECTION\PHENYLEPHRINE
product(s) by strength(s)
1 ml phenylephrine hydrochloride 10 mg/ml injection
original product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 006416142 | NDA | West-Ward Pharmaceuticals Corp. | 2012-12-18 | PHENYLEPHRINE HYDROCHLORIDE | INTRAVENOUS | INJECTION | NDA203826 | e1a7ab4b-0afe-4463-a039-5be0323cf2f7 |
relabeler product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 525840016 | UNAPPROVED DRUG OTHER MARKETING CATEGORY | General Injecatables & Vaccines, Inc | 2010-08-01 | PHENYLEPHRINE HYDROCHLORIDE | INTRAMUSCULAR | INJECTION, SOLUTION | 100190163 | b6d3c9af-53f7-4c14-8608-f41a3ef9894d | ||
| 2 | 525840142 | NDA | General Injecatables & Vaccines, Inc | 2013-04-02 | PHENYLEPHRINE HYDROCHLORIDE | INTRAVENOUS | INJECTION | 006416142 | NDA203826 | 46c75ffd-d03a-420e-ae71-10ffffd94321 | |
| 3 | 525840299 | UNAPPROVED DRUG OTHER MARKETING CATEGORY | General Injecatables & Vaccines, Inc | 2012-01-25 | PHENYLEPHRINE HYDROCHLORIDE | INTRAMUSCULAR | INJECTION, SOLUTION | 005170299 | 4256b3c7-23c5-4743-a311-916cee1de1c1 | ||
| 4 | 525840800 | Neo-Synephrine | UNAPPROVED DRUG OTHER MARKETING CATEGORY | General Injecatables & Vaccines, Inc | 2010-08-01 | PHENYLEPHRINE HYDROCHLORIDE | INTRAMUSCULAR | INJECTION, SOLUTION | 004091800 | 09f988b2-e313-4568-964e-fe1f23ab2b59 | |
| 5 | 551542852 | UNAPPROVED DRUG OTHER MARKETING CATEGORY | Cardinal Health | 2010-04-09 | PHENYLEPHRINE HYDROCHLORIDE | INTRAMUSCULAR | INJECTION | 100190163 | bc7981a2-b950-4e27-9aef-a3f6d2d39039 | ||
| 6 | 551545128 | NDA | Cardinal Health | 2012-12-20 | PHENYLEPHRINE HYDROCHLORIDE | INTRAMUSCULAR | INJECTION | 006416088 | NDA203826 | 7dfaac8d-ceab-4af0-9c44-bed73414789d | |
| 7 | 551545735 | UNAPPROVED DRUG OTHER MARKETING CATEGORY | Cardinal Health | 1990-09-30 | PHENYLEPHRINE HYDROCHLORIDE | INTRAMUSCULAR | INJECTION, SOLUTION | 005170299 | 7ded7d58-56c3-41e3-94b1-a6bba34a91f0 |
application(s)
| # | id | title | applicant | approved | approved drug |
|---|---|---|---|---|---|
| 1 | NDA203826 | PHENYLEPHRINE HYDROCHLORIDE | WEST WARD PHARMACEUTICAL CORP | 2012-12-20 | NDA203826_001 |
| 2 | NDA204300 | VAZCULEP | ECLAT PHARMACEUTICALS LLC | 2014-06-27 | NDA204300_001, NDA204300_002, NDA204300_003 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|
| 1 | NDA203826_001 | RX | PHENYLEPHRINE HYDROCHLORIDE (10MG/ML) | SOLUTION | True | 2012-12-20 | PHENYLEPHRINE HYDROCHLORIDE |
| 2 | NDA204300_001 | RX | PHENYLEPHRINE HYDROCHLORIDE (10MG/ML) | SOLUTION | False | 2014-06-27 | VAZCULEP |
| 3 | NDA204300_002 | RX | PHENYLEPHRINE HYDROCHLORIDE (50MG/5ML) | SOLUTION | False | 2014-06-27 | VAZCULEP |
| 4 | NDA204300_003 | RX | PHENYLEPHRINE HYDROCHLORIDE (100MG/10ML) | SOLUTION | True | 2014-06-27 | VAZCULEP |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 09f988b2-e313-4568-964e-fe1f23ab2b59 (view SPL) | Neo-Synephrine HCL (Phenylephrine Hydrochloride) 10 mg/mL Injection, USP 1 mL Single Dose Ampule | prescription | Human Prescription | General Injecatables & Vaccines, Inc | 2010-08-31 | 1 | 525840800 | |
| 2 | 4256b3c7-23c5-4743-a311-916cee1de1c1 (view SPL) | Phenylephrine Hydrochloride 1% 10mg/mL SDV | prescription | Human Prescription | General Injecatables & Vaccines, Inc | 2012-01-25 | 1 | 525840299 | |
| 3 | 46c75ffd-d03a-420e-ae71-10ffffd94321 (view SPL) | Phenylephrine HCL Injection, USPRx onlyThese highlights do not include all the information needed to use PHENYLEPHRINE HYDROCHLORIDE safely and effectively. See full prescribing information for PHENYLEPHRINE HYDROCHLORIDE.PHENYLEPHRINE HYDROCHLORIDE injection, for intravenous useInitial U.S. Approval: 2012 | prescription | Human Prescription | General Injecatables & Vaccines, Inc | 2013-04-02 | 1 | 525840142 | |
| 4 | 7ded7d58-56c3-41e3-94b1-a6bba34a91f0 (view SPL) | PHENYLEPHRINE HYDROCHLORIDE INJECTION, USP 1% | prescription | Human Prescription | Cardinal Health | REPACK | 2012-07-03 | 2 | 551545735 |
| 5 | 7dfaac8d-ceab-4af0-9c44-bed73414789d (view SPL) | PhenylephrineHydrochloride Injection, USPRx only CONTAINS NO ANTIMICROBIAL PRESERVATIVE | prescription | Human Prescription | Cardinal Health | REPACK | 2013-03-18 | 1 | 551545128 |
| 6 | 84134033-79e4-4660-a3bf-7adfd90fd01d (view SPL) | PhenylephrineHydrochloride Injection, USPRx only CONTAINS NO ANTIMICROBIAL PRESERVATIVE | prescription | Human Prescription | West-Ward Pharmaceuticals Corp. | ANALYSIS, LABEL, MANUFACTURE | 2011-08-24 | 4 | 006416088 |
| 7 | b6d3c9af-53f7-4c14-8608-f41a3ef9894d (view SPL) | Phenylephrine HCL 1 mL fill in 2 mL 10 mg/mL Injection, USP Single Dose Vial | prescription | Human Prescription | General Injecatables & Vaccines, Inc | 2011-04-26 | 3 | 525840016 | |
| 8 | bc7981a2-b950-4e27-9aef-a3f6d2d39039 (view SPL) | Phenylephrine Hydrochloride Injection, USP | prescription | Human Prescription | Cardinal Health | REPACK | 2013-04-04 | 4 | 551542852 |
| 9 | e1a7ab4b-0afe-4463-a039-5be0323cf2f7 (view SPL) | These highlights do not include all the information needed to usePHENYLEPHRINE HYDROCHLORIDE safely and effectively. See full prescribing information for PHENYLEPHRINE HYDROCHLORIDE. PHENYLEPHRINE HYDROCHLORIDE injection, for intravenous useInitial U.S. Approval: 2012 | prescription | Human Prescription | West-Ward Pharmaceuticals Corp. | ANALYSIS, LABEL, MANUFACTURE | 2014-06-03 | 6 | 006416142 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII