FDA.reportPublic FDA data

epinephrine

Product NDC
0115-1694
11-digit product format
001151694
Labeler code
0115
Product ID
0115-1694_fdafd090-bed3-4f16-8ab1-fd1573aa633e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
epinephrine
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Amneal Pharmaceuticals of New York LLC
Application
NDA020800
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2010-04-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
epinephrine
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYKH834O4BH
Rxcui1870225, 1870230

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7480e90b-004b-ebe4-2243-4f2fefdd9e78Product name220260128
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49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
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b5b1095b-40cd-8a9e-b111-502545045b07Product name420250325
e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
26005090-31a1-441d-920b-db3101a55d53Product name320250221
1c39b897-7219-42a1-9f3a-ec86cfd7b04bProduct name320250218
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
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362d7abb-94e6-4c60-9a58-266894157713Product name120231023
0a278166-c8aa-41b6-b4a5-6ac332bde76aProduct name120230718
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
c76bcd0f-25eb-471e-b970-1956c95c26c5Product name120230425
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
36390b75-5438-47d3-af60-732a654e9025Product name220220110
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
387afa72-0c5a-0d6b-ee2c-60c3506659e8Product name620210518
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
1b8ea3ec-88bd-98ea-c961-00ae340b5b14Product name220200220
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
3aa5a017-61e9-0c89-adef-13e7964d22f0Product name320171208
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
00358076-c817-430b-b924-11d717dc307cProduct name120160718
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c3c27a99-b8bc-4955-841c-26555f58ee7eProduct name120150421
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
669af5aa-14f3-3df7-f100-5f580ffd43c1Product name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
6ff3bab7-2dce-8bea-d7ce-54687f0c01fbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8bb82a1c-d0d0-fc27-011f-172e545f0382Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
bc98cf6f-a973-7162-5e30-0e7dd8c56bc3Product name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
cb03406d-e223-80bb-67d8-be80f9b6a4f2Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0115-1694-302021-02-05C16284748780-1ba0f9c33-3c09-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use EPINEPHRINE INJECTION safely and effectively. See full prescribing information for EPINEPHRINE INJECTION. EPINEPHRINE injection, for intramuscular or subcutaneous use Initial U.S. Approval: 1939
0115-1694-492021-02-05C16284748780-1ba0f9c33-3c09-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use EPINEPHRINE INJECTION safely and effectively. See full prescribing information for EPINEPHRINE INJECTION. EPINEPHRINE injection, for intramuscular or subcutaneous use Initial U.S. Approval: 1939
0115-1694-302021-01-29C16284748780-1ba0f9c33-3c09-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use EPINEPHRINE INJECTION safely and effectively. See full prescribing information for EPINEPHRINE INJECTION. EPINEPHRINE injection, for intramuscular or subcutaneous use Initial U.S. Approval: 1939
0115-1694-492021-01-29C16284748780-1ba0f9c33-3c09-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use EPINEPHRINE INJECTION safely and effectively. See full prescribing information for EPINEPHRINE INJECTION. EPINEPHRINE injection, for intramuscular or subcutaneous use Initial U.S. Approval: 1939

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0115-1694-30epinephrine1 in 1 CARTONINJECTION116
0115-1694-30epinephrine1 in 1 CASEINJECTION116
0115-1694-49epinephrine2 in 1 CARTONINJECTION216
0115-1694-49epinephrine1 in 1 CASEINJECTION116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-1694-30EA - Each0115-1694d7a54aa3-12ed-470a-9854-11cd9459135712019-06-19
0115-1694-49EA - Each0115-16948f59b63e-d9a0-4426-8607-bce9aae464a212017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-1694EPINEPHRINE INJECTION [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]13Current NDC, Legacy NDC, 4 package rows20241122_e13f05f1-7d21-49bb-b8d5-24bf9301c3d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1870225EPINEPHrine (generic for Adrenaclick) 0.15 MG in 0.15 ML Auto-InjectorPSNe13f05f1-7d21-49bb-b8d5-24bf9301c3d716
1870230EPINEPHrine (generic for Adrenaclick) 0.3 MG in 0.3 ML Auto-InjectorPSNe13f05f1-7d21-49bb-b8d5-24bf9301c3d716
1870225NDA020800 0.15 ML epinephrine 1 MG/ML Auto-InjectorSCDe13f05f1-7d21-49bb-b8d5-24bf9301c3d716
1870230NDA020800 0.3 ML epinephrine 1 MG/ML Auto-InjectorSCDe13f05f1-7d21-49bb-b8d5-24bf9301c3d716
1870225epinephrine (generic for Adrenaclick) 0.15 MG per 0.15 ML Auto-InjectorSYe13f05f1-7d21-49bb-b8d5-24bf9301c3d716
1870230epinephrine (generic for Adrenaclick) 0.3 MG per 0.3 ML Auto-InjectorSYe13f05f1-7d21-49bb-b8d5-24bf9301c3d716
1870230EPINEPHrine (generic for Adrenaclick) 0.3 MG in 0.3 ML Auto-InjectorPSN28642ad9-b839-ce3a-e063-6394a90ab86615
1870230NDA020800 0.3 ML epinephrine 1 MG/ML Auto-InjectorSCD28642ad9-b839-ce3a-e063-6394a90ab86615
1870230epinephrine (generic for Adrenaclick) 0.3 MG per 0.3 ML Auto-InjectorSY28642ad9-b839-ce3a-e063-6394a90ab86615
1870230EPINEPHrine (generic for Adrenaclick) 0.3 MG in 0.3 ML Auto-InjectorPSNa5134e63-9a31-4573-826f-b442d069b3e613
1870230EPINEPHrine (generic for Adrenaclick) 0.3 MG in 0.3 ML Auto-InjectorPSNc66de0d3-3b0f-4e52-a712-60357a10767613
1870230NDA020800 0.3 ML epinephrine 1 MG/ML Auto-InjectorSCDa5134e63-9a31-4573-826f-b442d069b3e613
1870230NDA020800 0.3 ML epinephrine 1 MG/ML Auto-InjectorSCDc66de0d3-3b0f-4e52-a712-60357a10767613
1870230epinephrine (generic for Adrenaclick) 0.3 MG per 0.3 ML Auto-InjectorSYa5134e63-9a31-4573-826f-b442d069b3e613
1870230epinephrine (generic for Adrenaclick) 0.3 MG per 0.3 ML Auto-InjectorSYc66de0d3-3b0f-4e52-a712-60357a10767613
1870225EPINEPHrine (generic for Adrenaclick) 0.15 MG in 0.15 ML Auto-InjectorPSN75dbc3f5-9caf-9f55-e053-2a91aa0a47197
1870230EPINEPHrine (generic for Adrenaclick) 0.3 MG in 0.3 ML Auto-InjectorPSN75dbc3f5-9caf-9f55-e053-2a91aa0a47197
1870225NDA020800 0.15 ML epinephrine 1 MG/ML Auto-InjectorSCD75dbc3f5-9caf-9f55-e053-2a91aa0a47197
1870230NDA020800 0.3 ML epinephrine 1 MG/ML Auto-InjectorSCD75dbc3f5-9caf-9f55-e053-2a91aa0a47197
1870225epinephrine (generic for Adrenaclick) 0.15 MG per 0.15 ML Auto-InjectorSY75dbc3f5-9caf-9f55-e053-2a91aa0a47197
1870230epinephrine (generic for Adrenaclick) 0.3 MG per 0.3 ML Auto-InjectorSY75dbc3f5-9caf-9f55-e053-2a91aa0a47197
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilPSNbae7a52f-504b-416e-afdd-e6853e2d59445
212033aspirin 325 MG Oral TabletPSNbae7a52f-504b-416e-afdd-e6853e2d59445
211874BAYER Aspirin 325 MG Oral TabletPSNbae7a52f-504b-416e-afdd-e6853e2d59445
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSNbae7a52f-504b-416e-afdd-e6853e2d59445
1049633diphenhydrAMINE HCl 50 MG/ML Injectable SolutionPSNbae7a52f-504b-416e-afdd-e6853e2d59445
1870225EPINEPHrine (generic for Adrenaclick) 0.15 MG in 0.15 ML Auto-InjectorPSNbae7a52f-504b-416e-afdd-e6853e2d59445
1870230EPINEPHrine (generic for Adrenaclick) 0.3 MG in 0.3 ML Auto-InjectorPSNbae7a52f-504b-416e-afdd-e6853e2d59445
310519glucose 4 GM Chewable TabletPSNbae7a52f-504b-416e-afdd-e6853e2d59445
198039nitroglycerin 0.4 MG Sublingual TabletPSNbae7a52f-504b-416e-afdd-e6853e2d59445
211874aspirin 325 MG Oral Tablet [Bayer Aspirin]SBDbae7a52f-504b-416e-afdd-e6853e2d59445
212033aspirin 325 MG Oral TabletSCDbae7a52f-504b-416e-afdd-e6853e2d59445
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCDbae7a52f-504b-416e-afdd-e6853e2d59445
1049633diphenhydramine hydrochloride 50 MG/ML Injectable SolutionSCDbae7a52f-504b-416e-afdd-e6853e2d59445
310519glucose 4000 MG Chewable TabletSCDbae7a52f-504b-416e-afdd-e6853e2d59445
2123111NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCDbae7a52f-504b-416e-afdd-e6853e2d59445
1870225NDA020800 0.15 ML epinephrine 1 MG/ML Auto-InjectorSCDbae7a52f-504b-416e-afdd-e6853e2d59445
1870230NDA020800 0.3 ML epinephrine 1 MG/ML Auto-InjectorSCDbae7a52f-504b-416e-afdd-e6853e2d59445
198039nitroglycerin 0.4 MG Sublingual TabletSCDbae7a52f-504b-416e-afdd-e6853e2d59445
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilSYbae7a52f-504b-416e-afdd-e6853e2d59445
212033ASA 325 MG Oral TabletSYbae7a52f-504b-416e-afdd-e6853e2d59445
211874ASA 325 MG Oral Tablet [Bayer Aspirin]SYbae7a52f-504b-416e-afdd-e6853e2d59445
211874Bayer Aspirin 325 MG Oral TabletSYbae7a52f-504b-416e-afdd-e6853e2d59445
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSYbae7a52f-504b-416e-afdd-e6853e2d59445
1049633diphenhydramine HCl 50 MG/ML Injectable SolutionSYbae7a52f-504b-416e-afdd-e6853e2d59445
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSYbae7a52f-504b-416e-afdd-e6853e2d59445
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSYbae7a52f-504b-416e-afdd-e6853e2d59445
1870225epinephrine (generic for Adrenaclick) 0.15 MG per 0.15 ML Auto-InjectorSYbae7a52f-504b-416e-afdd-e6853e2d59445
1870230epinephrine (generic for Adrenaclick) 0.3 MG per 0.3 ML Auto-InjectorSYbae7a52f-504b-416e-afdd-e6853e2d59445
310519glucose 4 GM Chewable TabletSYbae7a52f-504b-416e-afdd-e6853e2d59445
198039nitroglycerin 400 MCG Sublingual TabletSYbae7a52f-504b-416e-afdd-e6853e2d59445
198039NTG 0.4 MG Sublingual TabletSYbae7a52f-504b-416e-afdd-e6853e2d59445
198039TNG 0.4 MG Sublingual TabletSYbae7a52f-504b-416e-afdd-e6853e2d59445
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilPSN58d78805-3e8c-4859-b2e0-e3089f9252804
212033aspirin 325 MG Oral TabletPSN58d78805-3e8c-4859-b2e0-e3089f9252804
211874BAYER Aspirin 325 MG Oral TabletPSN58d78805-3e8c-4859-b2e0-e3089f9252804
1049633diphenhydrAMINE HCl 50 MG/ML Injectable SolutionPSN58d78805-3e8c-4859-b2e0-e3089f9252804
1870230EPINEPHrine (generic for Adrenaclick) 0.3 MG in 0.3 ML Auto-InjectorPSN58d78805-3e8c-4859-b2e0-e3089f9252804
310519glucose 4 GM Chewable TabletPSN58d78805-3e8c-4859-b2e0-e3089f9252804
198039nitroglycerin 0.4 MG Sublingual TabletPSN58d78805-3e8c-4859-b2e0-e3089f9252804
211874aspirin 325 MG Oral Tablet [Bayer Aspirin]SBD58d78805-3e8c-4859-b2e0-e3089f9252804
212033aspirin 325 MG Oral TabletSCD58d78805-3e8c-4859-b2e0-e3089f9252804
1049633diphenhydramine hydrochloride 50 MG/ML Injectable SolutionSCD58d78805-3e8c-4859-b2e0-e3089f9252804
310519glucose 4000 MG Chewable TabletSCD58d78805-3e8c-4859-b2e0-e3089f9252804
2123111NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCD58d78805-3e8c-4859-b2e0-e3089f9252804
1870230NDA020800 0.3 ML epinephrine 1 MG/ML Auto-InjectorSCD58d78805-3e8c-4859-b2e0-e3089f9252804
198039nitroglycerin 0.4 MG Sublingual TabletSCD58d78805-3e8c-4859-b2e0-e3089f9252804
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilSY58d78805-3e8c-4859-b2e0-e3089f9252804
212033ASA 325 MG Oral TabletSY58d78805-3e8c-4859-b2e0-e3089f9252804
211874ASA 325 MG Oral Tablet [Bayer Aspirin]SY58d78805-3e8c-4859-b2e0-e3089f9252804
211874Bayer Aspirin 325 MG Oral TabletSY58d78805-3e8c-4859-b2e0-e3089f9252804
1049633diphenhydramine HCl 50 MG/ML Injectable SolutionSY58d78805-3e8c-4859-b2e0-e3089f9252804
1870230epinephrine (generic for Adrenaclick) 0.3 MG per 0.3 ML Auto-InjectorSY58d78805-3e8c-4859-b2e0-e3089f9252804
310519glucose 4 GM Chewable TabletSY58d78805-3e8c-4859-b2e0-e3089f9252804
198039nitroglycerin 400 MCG Sublingual TabletSY58d78805-3e8c-4859-b2e0-e3089f9252804
198039NTG 0.4 MG Sublingual TabletSY58d78805-3e8c-4859-b2e0-e3089f9252804
198039TNG 0.4 MG Sublingual TabletSY58d78805-3e8c-4859-b2e0-e3089f9252804
1870230EPINEPHrine (generic for Adrenaclick) 0.3 MG in 0.3 ML Auto-InjectorPSNf4d7aca4-0acd-74c2-e053-2995a90a9d942
1870230EPINEPHrine (generic for Adrenaclick) 0.3 MG in 0.3 ML Auto-InjectorPSN677bcf31-c1e0-4d82-e053-2991aa0ac2ff2
1870230EPINEPHrine (generic for Adrenaclick) 0.3 MG in 0.3 ML Auto-InjectorPSNe7798493-9407-4a5d-9c90-0cc336c59ec12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0115-1694-30001151694301 CASE in 1 CARTON (0115-1694-30) / 1 SYRINGE, GLASS in 1 CASE / .3 mL in 1 SYRINGE, GLASS1 case2010-04-010000-00-00NoNoCurrent
0115-1694-49001151694492 CASE in 1 CARTON (0115-1694-49) / 1 SYRINGE, GLASS in 1 CASE / .3 mL in 1 SYRINGE, GLASS2 case2010-04-010000-00-00NoNoCurrent