Epinephrine

Product NDC
67296-1946
11-digit product format
672961946
Labeler code
67296
Product ID
67296-1946_3d92ba47-9b9a-b44f-e063-6394a90ac286
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Epinephrine
Dosage form
INJECTION
Route
INTRAMUSCULAR; SUBCUTANEOUS
Labeler
Redpharm Drug
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090589-001EPINEPHRINE (AUTOINJECTOR)EPINEPHRINE0.3MG/DELIVERYINJECTABLE / INTRAMUSCULAR, SUBCUTANEOUSAB2018-08-16
A090589-002EPINEPHRINE (AUTOINJECTOR)EPINEPHRINE0.15MG/DELIVERYINJECTABLE / INTRAMUSCULAR, SUBCUTANEOUSAB2018-08-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A090589-001AB
A090589-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090589-001EPINEPHRINE (AUTOINJECTOR)0.3MG/DELIVERYINJECTABLE / INTRAMUSCULAR, SUBCUTANEOUSAB2018-08-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090589-002EPINEPHRINE (AUTOINJECTOR)0.15MG/DELIVERYINJECTABLE / INTRAMUSCULAR, SUBCUTANEOUSAB2018-08-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090589-001EPINEPHRINE (AUTOINJECTOR)0.3MG/DELIVERYINJECTABLE / INTRAMUSCULAR, SUBCUTANEOUSAB2018-08-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090589-002EPINEPHRINE (AUTOINJECTOR)0.15MG/DELIVERYINJECTABLE / INTRAMUSCULAR, SUBCUTANEOUSAB2018-08-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A090589-001EPINEPHRINE (AUTOINJECTOR)0.3MG/DELIVERYINJECTABLE / INTRAMUSCULAR, SUBCUTANEOUSAB2018-08-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090589-002EPINEPHRINE (AUTOINJECTOR)0.15MG/DELIVERYINJECTABLE / INTRAMUSCULAR, SUBCUTANEOUSAB2018-08-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090589-001EPINEPHRINE (AUTOINJECTOR)0.3MG/DELIVERYINJECTABLE / INTRAMUSCULAR, SUBCUTANEOUSAB2018-08-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090589-002EPINEPHRINE (AUTOINJECTOR)0.15MG/DELIVERYINJECTABLE / INTRAMUSCULAR, SUBCUTANEOUSAB2018-08-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090589-001EPINEPHRINE (AUTOINJECTOR)0.3MG/DELIVERYINJECTABLE / INTRAMUSCULAR, SUBCUTANEOUSAB2018-08-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090589-002EPINEPHRINE (AUTOINJECTOR)0.15MG/DELIVERYINJECTABLE / INTRAMUSCULAR, SUBCUTANEOUSAB2018-08-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090589-001EPINEPHRINE (AUTOINJECTOR)0.3MG/DELIVERYINJECTABLE / INTRAMUSCULAR, SUBCUTANEOUSAB2018-08-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090589-002EPINEPHRINE (AUTOINJECTOR)0.15MG/DELIVERYINJECTABLE / INTRAMUSCULAR, SUBCUTANEOUSAB2018-08-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090589-001EPINEPHRINE (AUTOINJECTOR)0.3MG/DELIVERYINJECTABLE / INTRAMUSCULAR, SUBCUTANEOUSAB2018-08-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090589-002EPINEPHRINE (AUTOINJECTOR)0.15MG/DELIVERYINJECTABLE / INTRAMUSCULAR, SUBCUTANEOUSAB2018-08-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090589-001EPINEPHRINE (AUTOINJECTOR)0.3MG/DELIVERYINJECTABLE / INTRAMUSCULAR, SUBCUTANEOUSAB2018-08-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090589-002EPINEPHRINE (AUTOINJECTOR)0.15MG/DELIVERYINJECTABLE / INTRAMUSCULAR, SUBCUTANEOUSAB2018-08-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090589-001EPINEPHRINE (AUTOINJECTOR)0.3MG/DELIVERYINJECTABLE / INTRAMUSCULAR, SUBCUTANEOUSAB2018-08-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090589-002EPINEPHRINE (AUTOINJECTOR)0.15MG/DELIVERYINJECTABLE / INTRAMUSCULAR, SUBCUTANEOUSAB2018-08-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090589-001EPINEPHRINE (AUTOINJECTOR)0.3MG/DELIVERYINJECTABLE / INTRAMUSCULAR, SUBCUTANEOUSAB2018-08-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A090589-002EPINEPHRINE (AUTOINJECTOR)0.15MG/DELIVERYINJECTABLE / INTRAMUSCULAR, SUBCUTANEOUSAB2018-08-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090589-001EPINEPHRINE (AUTOINJECTOR)0.3MG/DELIVERYINJECTABLE / INTRAMUSCULAR, SUBCUTANEOUSAB2018-08-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090589-002EPINEPHRINE (AUTOINJECTOR)0.15MG/DELIVERYINJECTABLE / INTRAMUSCULAR, SUBCUTANEOUSAB2018-08-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090589-001EPINEPHRINE (AUTOINJECTOR)0.3MG/DELIVERYINJECTABLE / INTRAMUSCULAR, SUBCUTANEOUSAB2018-08-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090589-002EPINEPHRINE (AUTOINJECTOR)0.15MG/DELIVERYINJECTABLE / INTRAMUSCULAR, SUBCUTANEOUSAB2018-08-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090589-001EPINEPHRINE (AUTOINJECTOR)0.3MG/DELIVERYINJECTABLE / INTRAMUSCULAR, SUBCUTANEOUSAB2018-08-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090589-002EPINEPHRINE (AUTOINJECTOR)0.15MG/DELIVERYINJECTABLE / INTRAMUSCULAR, SUBCUTANEOUSAB2018-08-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090589-001EPINEPHRINE (AUTOINJECTOR)0.3MG/DELIVERYINJECTABLE / INTRAMUSCULAR, SUBCUTANEOUSAB2018-08-168072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090589-002EPINEPHRINE (AUTOINJECTOR)0.15MG/DELIVERYINJECTABLE / INTRAMUSCULAR, SUBCUTANEOUSAB2018-08-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090589-001EPINEPHRINE (AUTOINJECTOR)0.3MG/DELIVERYINJECTABLE / INTRAMUSCULAR, SUBCUTANEOUSAB2018-08-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090589-002EPINEPHRINE (AUTOINJECTOR)0.15MG/DELIVERYINJECTABLE / INTRAMUSCULAR, SUBCUTANEOUSAB2018-08-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090589-001EPINEPHRINE (AUTOINJECTOR)0.3MG/DELIVERYINJECTABLE / INTRAMUSCULAR, SUBCUTANEOUSAB2018-08-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090589-002EPINEPHRINE (AUTOINJECTOR)0.15MG/DELIVERYINJECTABLE / INTRAMUSCULAR, SUBCUTANEOUSAB2018-08-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090589-001EPINEPHRINE (AUTOINJECTOR)0.3MG/DELIVERYINJECTABLE / INTRAMUSCULAR, SUBCUTANEOUSAB2018-08-164b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090589-002EPINEPHRINE (AUTOINJECTOR)0.15MG/DELIVERYINJECTABLE / INTRAMUSCULAR, SUBCUTANEOUSAB2018-08-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090589-001EPINEPHRINE (AUTOINJECTOR)0.3MG/DELIVERYINJECTABLE / INTRAMUSCULAR, SUBCUTANEOUSAB2018-08-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090589-002EPINEPHRINE (AUTOINJECTOR)0.15MG/DELIVERYINJECTABLE / INTRAMUSCULAR, SUBCUTANEOUSAB2018-08-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090589-001EPINEPHRINE (AUTOINJECTOR)0.3MG/DELIVERYINJECTABLE / INTRAMUSCULAR, SUBCUTANEOUSAB2018-08-16bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090589-002EPINEPHRINE (AUTOINJECTOR)0.15MG/DELIVERYINJECTABLE / INTRAMUSCULAR, SUBCUTANEOUSAB2018-08-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090589-001EPINEPHRINE (AUTOINJECTOR)0.3MG/DELIVERYINJECTABLE / INTRAMUSCULAR, SUBCUTANEOUSAB2018-08-16782e0a99824c…
2021-12-28 21:50 UTC2021-12A090589-002EPINEPHRINE (AUTOINJECTOR)0.15MG/DELIVERYINJECTABLE / INTRAMUSCULAR, SUBCUTANEOUSAB2018-08-16782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 81 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090589-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090589-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090589-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090589-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090589-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090589-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090589-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090589-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090589-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090589-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090589-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090589-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090589-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090589-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090589-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090589-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090589-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090589-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090589-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090589-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090589-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090589-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090589-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090589-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090589-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090589-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090589-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090589-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090589-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090589-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090589-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090589-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090589-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090589-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090589-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090589-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090589-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090589-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090589-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090589-002AB1782e0a99824c…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
YKH834O4BHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1870207Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
300ac735-4493-c02a-e063-6294a90a5bceAvailable on FDA.report

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
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1946-2Epinephrine1 in 1 CONTAINERINJECTION12
67296-1946-2Epinephrine2 in 1 CARTONINJECTION22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1946EPINEPHRINE INJECTION [REDPHARM DRUG]1Current NDC, 2 package rows20250312_300ac735-4493-c02a-e063-6294a90a5bce.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EpinephrineEPINEPHRINESportpharm LLC3a8f5ca2-6c1d-4011-9266-ba93c7a3abb92026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090589
application number: ANDA090589
EpinephrineEPINEPHRINEREMEDYREPACK INC.de4916c5-bdc8-4da9-a857-a319882a831a2026-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090589
application number: ANDA090589
EpinephrineEPINEPHRINEA-S Medication Solutionsab5e23d0-6e99-4647-838d-23a4040602b52025-11-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090589
application number: ANDA090589
EpinephrineEPINEPHRINERedpharm Drug300ac735-4493-c02a-e063-6294a90a5bce2025-08-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090589
application number: ANDA090589
ndc (product): 67296-1946
EpinephrineEPINEPHRINEBryant Ranch Prepacka7ae17f8-de81-4de9-a89f-bb930c6a27ec2024-01-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090589
application number: ANDA090589
EpinephrineEPINEPHRINEAsclemed USA, Inc.099bc72c-8ffe-4b8c-9608-044c864982fb2022-10-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090589
application number: ANDA090589
EpinephrineEPINEPHRINETeva Pharmaceuticals USA, Inc.04f07f15-55e2-411b-abb8-07eab37f56642021-01-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090589
application number: ANDA090589

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1870207EPINEPHrine (generic for EpiPen) 0.3 MG in 0.3 ML Auto-InjectorPSN300ac735-4493-c02a-e063-6294a90a5bce2
1870207NDA019430 0.3 ML epinephrine 1 MG/ML Auto-InjectorSCD300ac735-4493-c02a-e063-6294a90a5bce2
1870207epinephrine (generic for EpiPen) 0.3 MG per 0.3 ML Auto-InjectorSY300ac735-4493-c02a-e063-6294a90a5bce2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67296-1946-2672961946022 CONTAINER in 1 CARTON (67296-1946-2) / 1 SYRINGE in 1 CONTAINER / .3 mL in 1 SYRINGE2 container2018-11-27NoNoCurrent