EpiPen
- Product NDC
- 55045-3207
- 11-digit product format
- 550453207
- Labeler code
- 55045
- Product ID
- 55045-3207_f72addbb-85a1-4830-b6db-c2e964b03385
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Epinephrine
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR
- Labeler
- Dispensing Solutions, Inc.
- 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 |
|---|---|---|---|---|---|
| 55045-3207-2 | 2019-11-13 | C162847 | 48780-1 | 97449f38-b786-f6ea-e053-dbdaa90aa703 | EpiPen ® (epinephrine) Auto-Injector 0.3 mg EpiPen ® = one dose of 0.30 mg epinephrine (USP, 1:1000, 0.3 mL) EpiPen ® JR (epinephrine) Auto-Injector 0.15 mg EpiPen ® Jr = one dose of 0.15 mg epinephrine (USP, 1:2000, 0.3 mL) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55045-3207-2 | EpiPen | 1 in 1 CONTAINER | INJECTION | 1 | 2 | |
| 55045-3207-2 | EpiPen | 1 in 1 CARTON | INJECTION | 1 | 2 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Epinephrine | ACTIVE INGREDIENT | YKH834O4BH | EPIPEN (EPINEPHRINE) INJECTION [DISPENSING SOLUTIONS, INC.] | 2 | |
| Epinephrine | ACTIVE MOIETY | YKH834O4BH | EPIPEN (EPINEPHRINE) INJECTION [DISPENSING SOLUTIONS, INC.] | 2 | |
| Hydrochloric Acid | INACTIVE INGREDIENT | QTT17582CB | EPIPEN (EPINEPHRINE) INJECTION [DISPENSING SOLUTIONS, INC.] | 2 | |
| Nitrogen | INACTIVE INGREDIENT | N762921K75 | EPIPEN (EPINEPHRINE) INJECTION [DISPENSING SOLUTIONS, INC.] | 2 | |
| Sodium Chloride | INACTIVE INGREDIENT | 451W47IQ8X | EPIPEN (EPINEPHRINE) INJECTION [DISPENSING SOLUTIONS, INC.] | 2 | |
| Sodium Metabisulfite | INACTIVE INGREDIENT | 4VON5FNS3C | EPIPEN (EPINEPHRINE) INJECTION [DISPENSING SOLUTIONS, INC.] | 2 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | EPIPEN (EPINEPHRINE) INJECTION [DISPENSING SOLUTIONS, INC.] | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55045-3207 | EPIPEN (EPINEPHRINE) INJECTION [DISPENSING SOLUTIONS, INC.] | 2 | Legacy NDC, 2 package rows | 20120926_f3f1a483-e29a-4e3e-b677-16fa87fe5e5a.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1870207 | EPINEPHrine (generic for EpiPen) 0.3 MG in 0.3 ML Auto-Injector | PSN | f3f1a483-e29a-4e3e-b677-16fa87fe5e5a | 2 |
| 727347 | EpiPen 0.3 MG in 0.3 ML Auto-Injector | PSN | f3f1a483-e29a-4e3e-b677-16fa87fe5e5a | 2 |
| 727347 | NDA019430 0.3 ML epinephrine 1 MG/ML Auto-Injector [Epipen] | SBD | f3f1a483-e29a-4e3e-b677-16fa87fe5e5a | 2 |
| 1870207 | NDA019430 0.3 ML epinephrine 1 MG/ML Auto-Injector | SCD | f3f1a483-e29a-4e3e-b677-16fa87fe5e5a | 2 |
| 727347 | 0.3 ML Epipen 1 MG/ML Auto-Injector | SY | f3f1a483-e29a-4e3e-b677-16fa87fe5e5a | 2 |
| 1870207 | epinephrine (generic for EpiPen) 0.3 MG per 0.3 ML Auto-Injector | SY | f3f1a483-e29a-4e3e-b677-16fa87fe5e5a | 2 |
| 727347 | Epipen 0.3 MG per 0.3 ML Auto-Injector | SY | f3f1a483-e29a-4e3e-b677-16fa87fe5e5a | 2 |
| 727347 | NDA019430 0.3 ML Epipen 1 MG/ML Auto-Injector | SY | f3f1a483-e29a-4e3e-b677-16fa87fe5e5a | 2 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 55045-3207-2 | 55045320702 | 1 in 1 CONTAINER | Historical |