FDA.reportPublic FDA data

EPINEPHRINE

Product NDC
51662-1708
Requested package NDC
51662-1708-3
11-digit product format
516621708
Labeler code
51662
Product ID
51662-1708_58b8f853-3b3b-74ba-e063-6394a90a8e1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
EPINEPHRINE
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA220562
Marketing category
ANDA
Marketing start
2026-06-08
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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A220562-001EPINEPHRINEEPINEPHRINE1MG/ML (1MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSAP2026-05-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A220562-001AP

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
2026-09-14 22:38:342026-08A220562-001EPINEPHRINE1MG/ML (1MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSAP2026-05-2984e616aacf4f…
2026-08-18 06:07:402026-07A220562-001EPINEPHRINE1MG/ML (1MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSAP2026-05-29caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220562-001EPINEPHRINE1MG/ML (1MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSAP2026-05-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A220562-001AP184e616aacf4f…
2026-08-18 06:07:402026-07A220562-001AP1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220562-001AP1a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

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
1660014Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5725a519-3ad6-7e5e-e063-6394a90a111fAvailable on FDA.report

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EPINEPHRINEEPINEPHRINEHF Acquisition Co LLC, DBA HealthFirst5725a519-3ad6-7e5e-e063-6394a90a111f2026-08-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 220562
application number: ANDA220562
ndc (package): 51662-1708-3
ndc (product): 51662-1708
ndc11 (package): 51662170803
EpinephrineEPINEPHRINEHikma Pharmaceuticals USA Inc.1e8ebac1-5b32-47f9-a930-86a98a24dccc2026-05-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 220562
application number: ANDA220562

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51662-1708-35166217080325 POUCH in 1 CASE (51662-1708-3) / 1 AMPULE in 1 POUCH (51662-1708-2) / 1 mL in 1 AMPULE (51662-1708-1) 25 pouch2026-06-08NoNoCurrent