EPIPEN
- Product NDC
- 64725-0500
- 11-digit product format
- 647250500
- Labeler code
- 64725
- Product ID
- 64725-0500_9fa83fd2-deeb-4996-8771-19f12e7ac629
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- epinephrine
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR
- Labeler
- TYA Pharmaceuticals
- Application
- NDA019430
- Marketing category
- NDA
- Marketing start
- 1987-12-22
- Marketing end
- 0000-00-00
- Substance
- EPINEPHRINE
- Active strength
- 0 mg/.3mL
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0b4ec9ca-d305-43fc-88dd-7a510313efe0 | Product name | 1 | 20260105 |
| bb209f42-a85f-4fee-9d3d-c9dded168625 | Product name | 1 | 20251208 |
| 49628fc7-2031-4c28-bd31-0ef3aa8f44a3 | Product name | 3 | 20251118 |
| cbf85893-59ef-423f-87d4-a573c000a8b9 | Product name | 8 | 20250731 |
| b5b1095b-40cd-8a9e-b111-502545045b07 | Product name | 4 | 20250325 |
| e190029e-423b-473c-8e04-2ada59b5b711 | Product name | 1 | 20250314 |
| e0031c74-3853-42bc-8e10-86dbbe83992e | Product name | 2 | 20231116 |
| f7046b89-2016-499a-adc6-78479172abc6 | Product name | 1 | 20230425 |
| 2686d634-e712-4007-8dbf-3d37c6c4d71f | Product name | 1 | 20181121 |
| fa8b5901-e681-426f-82fe-54f6d81ec698 | Product name | 4 | 20180619 |
| bd49bb86-2d32-4a7a-a594-eeda2e29af42 | Product name | 1 | 20180118 |
| c08ab52f-2fc8-4409-9d9f-ed8edc0bd070 | Product name | 1 | 20171221 |
| 3becbe78-12d9-4ad2-9b4c-1e36f8d1303a | Product name | 1 | 20170815 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 64725-0500-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-3901-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 1939 EPIPEN and EPIPEN Jr ® ® EPIPEN and EPIPEN Jr EPIPEN (epinephrine injection), Auto-Injector 0.3 mg, EPIPEN Jr (epinephrine injection) Auto-Injector 0.15 mg, for intramuscular or subcutaneous use ® ® |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 64725-0500-1 | EPIPEN | 1 mL in 1 CARTON | INJECTION | 1 | 4 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| EPINEPHRINE | ACTIVE INGREDIENT | YKH834O4BH | EPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [TYA PHARMACEUTICALS] | 4 | |
| EPINEPHRINE | ACTIVE MOIETY | YKH834O4BH | EPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [TYA PHARMACEUTICALS] | 4 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | EPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [TYA PHARMACEUTICALS] | 4 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | EPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [TYA PHARMACEUTICALS] | 4 | |
| SODIUM METABISULFITE | INACTIVE INGREDIENT | 4VON5FNS3C | EPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [TYA PHARMACEUTICALS] | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 64725-0500 | EPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [TYA PHARMACEUTICALS] | 4 | Legacy NDC, 1 package rows | 20141027_cb1b0dc7-6f5f-45fc-96c7-a6006b88fdc6.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 727316 | EPINEPHrine (generic for EpiPen Jr) 0.15 MG in 0.3 ML Auto-Injector | PSN | cb1b0dc7-6f5f-45fc-96c7-a6006b88fdc6 | 4 |
| 1870207 | EPINEPHrine (generic for EpiPen) 0.3 MG in 0.3 ML Auto-Injector | PSN | cb1b0dc7-6f5f-45fc-96c7-a6006b88fdc6 | 4 |
| 727347 | EpiPen 0.3 MG in 0.3 ML Auto-Injector | PSN | cb1b0dc7-6f5f-45fc-96c7-a6006b88fdc6 | 4 |
| 727386 | EpiPen Jr 0.15 MG in 0.3 ML Auto-Injector | PSN | cb1b0dc7-6f5f-45fc-96c7-a6006b88fdc6 | 4 |
| 727386 | NDA019430 0.3 ML epinephrine 0.5 MG/ML Auto-Injector [Epipen] | SBD | cb1b0dc7-6f5f-45fc-96c7-a6006b88fdc6 | 4 |
| 727347 | NDA019430 0.3 ML epinephrine 1 MG/ML Auto-Injector [Epipen] | SBD | cb1b0dc7-6f5f-45fc-96c7-a6006b88fdc6 | 4 |
| 727316 | NDA019430 0.3 ML epinephrine 0.5 MG/ML Auto-Injector | SCD | cb1b0dc7-6f5f-45fc-96c7-a6006b88fdc6 | 4 |
| 1870207 | NDA019430 0.3 ML epinephrine 1 MG/ML Auto-Injector | SCD | cb1b0dc7-6f5f-45fc-96c7-a6006b88fdc6 | 4 |
| 727347 | 0.3 ML Epipen 1 MG/ML Auto-Injector | SY | cb1b0dc7-6f5f-45fc-96c7-a6006b88fdc6 | 4 |
| 727316 | epinephrine (generic for EpiPen Jr) 0.15 MG per 0.3 ML Auto-Injector | SY | cb1b0dc7-6f5f-45fc-96c7-a6006b88fdc6 | 4 |
| 1870207 | epinephrine (generic for EpiPen) 0.3 MG per 0.3 ML Auto-Injector | SY | cb1b0dc7-6f5f-45fc-96c7-a6006b88fdc6 | 4 |
| 727347 | Epipen 0.3 MG per 0.3 ML Auto-Injector | SY | cb1b0dc7-6f5f-45fc-96c7-a6006b88fdc6 | 4 |
| 727386 | Epipen Jr 0.15 MG per 0.3 ML Auto-Injector | SY | cb1b0dc7-6f5f-45fc-96c7-a6006b88fdc6 | 4 |
| 727386 | NDA019430 0.3 ML Epipen 0.5 MG/ML Auto-Injector | SY | cb1b0dc7-6f5f-45fc-96c7-a6006b88fdc6 | 4 |
| 727347 | NDA019430 0.3 ML Epipen 1 MG/ML Auto-Injector | SY | cb1b0dc7-6f5f-45fc-96c7-a6006b88fdc6 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 64725-0500-1 | 64725050001 | 1 mL in 1 CARTON | 1 ml | Historical |