epinephrine

Product NDC
70121-1660
11-digit product format
701211660
Labeler code
70121
Product ID
70121-1660_b142feb8-f509-4fab-90ad-824623d0301e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
epinephrine
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA217485
Marketing category
ANDA
Marketing start
2025-10-14
Substance
EPINEPHRINE
Active strength
1 mg/mL
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217485-001EPINEPHRINEEPINEPHRINEEQ 30MG BASE/30ML (EQ 1MG BASE/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSAP2025-10-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217485-001AP

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A217485-001EPINEPHRINEEQ 30MG BASE/30ML (EQ 1MG BASE/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSAP2025-10-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217485-001EPINEPHRINEEQ 30MG BASE/30ML (EQ 1MG BASE/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSAP2025-10-1431067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217485-001EPINEPHRINEEQ 30MG BASE/30ML (EQ 1MG BASE/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSAP2025-10-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A217485-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217485-001AP131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217485-001AP1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EPINEPHRINE1 mg/mL

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
310132Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c0ef05d5-3fc8-4fb4-bf5b-c219ff17b092Available 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
70121-1660-2epinephrine1 mL in 1 VIAL, MULTI-DOSEINJECTION15
70121-1660-2epinephrine1 in 1 CARTONINJECTION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70121-1660-2ML - Milliliter70121-16609726f26a-7487-4e1a-a83c-9e8a3b62b21012026-04-20

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
epinephrineEPINEPHRINEAmneal Pharmaceuticals LLCc0ef05d5-3fc8-4fb4-bf5b-c219ff17b0922025-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217485
application number: ANDA217485
ndc (product): 70121-1660

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310132EPINEPHrine 1 MG/ML (1:1000) Injectable SolutionPSNc0ef05d5-3fc8-4fb4-bf5b-c219ff17b0925
310132epinephrine 1 MG/ML Injectable SolutionSCDc0ef05d5-3fc8-4fb4-bf5b-c219ff17b0925
310132epinephrine (as epinephrine hydrochloride) 1 MG/ML Injectable SolutionSYc0ef05d5-3fc8-4fb4-bf5b-c219ff17b0925
310132epinephrine 1:1000 Injectable SolutionSYc0ef05d5-3fc8-4fb4-bf5b-c219ff17b0925
310132epinephrine 500 MCG per 0.5 ML Injectable SolutionSYc0ef05d5-3fc8-4fb4-bf5b-c219ff17b0925

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70121-1660-2701211660021 VIAL, MULTI-DOSE in 1 CARTON (70121-1660-2) / 1 mL in 1 VIAL, MULTI-DOSE2025-10-14NoNoCurrent