NDC 0049-0520
Pfizerpen
Penicillin G Potassium
Pfizerpen is a Intramuscular; Intrapleural; Intrathecal; Intravenous Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Roerig. The primary component is Penicillin G Potassium.
| Product ID | 0049-0520_44c9fee1-e156-4f96-9fcd-d74213761ef2 |
| NDC | 0049-0520 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Pfizerpen |
| Generic Name | Penicillin G Potassium |
| Dosage Form | Powder, For Solution |
| Route of Administration | INTRAMUSCULAR; INTRAPLEURAL; INTRATHECAL; INTRAVENOUS |
| Marketing Start Date | 2010-06-01 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA060657 |
| Labeler Name | Roerig |
| Substance Name | PENICILLIN G POTASSIUM |
| Active Ingredient Strength | 5000000 [iU]/1 |
| Pharm Classes | Penicillin-class Antibacterial [EPC],Penicillins [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
Packaging
NDC 0049-0520-83
10 VIAL in 1 CARTON (0049-0520-83) > 1 POWDER, FOR SOLUTION in 1 VIAL (0049-0520-84)
| Marketing Start Date | 2010-06-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0049-0520-83 [00049052083]
Pfizerpen POWDER, FOR SOLUTION
| Marketing Category | ANDA |
| Application Number | ANDA060657 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2010-06-01 |
NDC 0049-0520-44 [00049052044]
Pfizerpen POWDER, FOR SOLUTION
| Marketing Category | ANDA |
| Application Number | ANDA060657 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2010-06-01 |
| Marketing End Date | 2012-01-31 |
NDC 0049-0520-84 [00049052084]
Pfizerpen POWDER, FOR SOLUTION
| Marketing Category | ANDA |
| Application Number | ANDA060657 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2015-12-09 |
NDC 0049-0520-22 [00049052022]
Pfizerpen POWDER, FOR SOLUTION
| Marketing Category | ANDA |
| Application Number | ANDA060657 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2010-06-01 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| PENICILLIN G POTASSIUM | 5000000 [iU]/1 |
OpenFDA Data
| SPL SET ID: | efef4846-9497-41af-8dd6-518f86eca7f2 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
Pharmacological Class
- Penicillin-class Antibacterial [EPC]
- Penicillins [CS]
NDC Crossover Matching brand name "Pfizerpen" or generic name "Penicillin G Potassium"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0049-0420 | Pfizerpen | penicillin G potassium |
| 0049-0430 | Pfizerpen | penicillin G potassium |
| 0049-0520 | Pfizerpen | penicillin G potassium |
| 0049-0530 | Pfizerpen | penicillin G potassium |
| 0781-6135 | Penicillin G Potassium | Penicillin G Potassium |
| 0781-6136 | Penicillin G Potassium | Penicillin G Potassium |
| 44567-310 | Penicillin G Potassium | Penicillin G Potassium |
| 44567-311 | Penicillin G Potassium | Penicillin G Potassium |
| 44567-312 | Penicillin G Potassium | Penicillin G Potassium |
| 70860-126 | Penicillin G Potassium | penicillin g potassium |
| 70860-127 | Penicillin G Potassium | penicillin g potassium |
Trademark Results [Pfizerpen]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PFIZERPEN 71694089 0629419 Live/Registered |
CHAS. PFIZER & CO., INC. 1955-09-01 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.