FDA.reportPublic FDA data

Epinephrine

Product NDC
0093-5986
11-digit product format
000935986
Labeler code
0093
Product ID
0093-5986_f96bd477-2239-4453-aaa4-e20d16c6e49e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Epinephrine
Dosage form
INJECTION
Route
INTRAMUSCULAR; SUBCUTANEOUS
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA090589
Marketing category
ANDA
Marketing start
2018-11-27
Substance
EPINEPHRINE
Active strength
.3 mg/.3mL
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Epinephrine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EPINEPHRINE.3 mg/.3mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYKH834O4BH
Rxcui727316, 1870207

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
bb209f42-a85f-4fee-9d3d-c9dded168625Product name120251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
b5b1095b-40cd-8a9e-b111-502545045b07Product name420250325
e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-5986-19Epinephrine0.3 mL in 1 SYRINGEINJECTION0.311
0093-5986-19Epinephrine1 in 1 CONTAINERINJECTION111
0093-5986-27Epinephrine2 in 1 CARTONINJECTION211

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-5986-19EA - Each0093-59861e5edbaa-7b53-4260-9ab9-56460dfebc9a12018-12-13
0093-5986-27EA - Each0093-598664f1f86d-c216-4263-93a5-546f1507b73f12018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-5986EPINEPHRINE INJECTION [TEVA PHARMACEUTICALS USA, INC.]11Current NDC, Legacy NDC, 3 package rows20211023_04f07f15-55e2-411b-abb8-07eab37f5664.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
727316EPINEPHrine (generic for EpiPen Jr) 0.15 MG in 0.3 ML Auto-InjectorPSN04f07f15-55e2-411b-abb8-07eab37f566411
1870207EPINEPHrine (generic for EpiPen) 0.3 MG in 0.3 ML Auto-InjectorPSN04f07f15-55e2-411b-abb8-07eab37f566411
727316NDA019430 0.3 ML epinephrine 0.5 MG/ML Auto-InjectorSCD04f07f15-55e2-411b-abb8-07eab37f566411
1870207NDA019430 0.3 ML epinephrine 1 MG/ML Auto-InjectorSCD04f07f15-55e2-411b-abb8-07eab37f566411
727316epinephrine (generic for EpiPen Jr) 0.15 MG per 0.3 ML Auto-InjectorSY04f07f15-55e2-411b-abb8-07eab37f566411
1870207epinephrine (generic for EpiPen) 0.3 MG per 0.3 ML Auto-InjectorSY04f07f15-55e2-411b-abb8-07eab37f566411
1870207EPINEPHrine (generic for EpiPen) 0.3 MG in 0.3 ML Auto-InjectorPSNde4916c5-bdc8-4da9-a857-a319882a831a9
1870207NDA019430 0.3 ML epinephrine 1 MG/ML Auto-InjectorSCDde4916c5-bdc8-4da9-a857-a319882a831a9
1870207epinephrine (generic for EpiPen) 0.3 MG per 0.3 ML Auto-InjectorSYde4916c5-bdc8-4da9-a857-a319882a831a9
1870207EPINEPHrine (generic for EpiPen) 0.3 MG in 0.3 ML Auto-InjectorPSN099bc72c-8ffe-4b8c-9608-044c864982fb2
1870207EPINEPHrine (generic for EpiPen) 0.3 MG in 0.3 ML Auto-InjectorPSN300ac735-4493-c02a-e063-6294a90a5bce2
1870207EPINEPHrine (generic for EpiPen) 0.3 MG in 0.3 ML Auto-InjectorPSN3a8f5ca2-6c1d-4011-9266-ba93c7a3abb92
1870207NDA019430 0.3 ML epinephrine 1 MG/ML Auto-InjectorSCD300ac735-4493-c02a-e063-6294a90a5bce2
1870207NDA019430 0.3 ML epinephrine 1 MG/ML Auto-InjectorSCD3a8f5ca2-6c1d-4011-9266-ba93c7a3abb92
1870207NDA019430 0.3 ML epinephrine 1 MG/ML Auto-InjectorSCD099bc72c-8ffe-4b8c-9608-044c864982fb2
1870207epinephrine (generic for EpiPen) 0.3 MG per 0.3 ML Auto-InjectorSY099bc72c-8ffe-4b8c-9608-044c864982fb2
1870207epinephrine (generic for EpiPen) 0.3 MG per 0.3 ML Auto-InjectorSY300ac735-4493-c02a-e063-6294a90a5bce2
1870207epinephrine (generic for EpiPen) 0.3 MG per 0.3 ML Auto-InjectorSY3a8f5ca2-6c1d-4011-9266-ba93c7a3abb92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-5986-19000935986190.3 mL in 1 SYRINGE0.3 mlHistorical
0093-5986-27000935986272 CONTAINER in 1 CARTON (0093-5986-27) / 1 SYRINGE in 1 CONTAINER (0093-5986-19) / .3 mL in 1 SYRINGE2 container2018-11-270000-00-00NoNoCurrent
0093-5986-99000935986991280 SYRINGE in 1 BOX (0093-5986-99) / 1 mL in 1 SYRINGE1280 syringe07-DEC-21Current