Epinephrine

Product NDC
70518-1215
Requested package NDC
70518-1215-0
11-digit product format
705181215
Labeler code
70518
Product ID
70518-1215_d9171343-f5a0-1663-e053-2995a90a4b3e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Epinephrine
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
REMEDYREPACK INC.
Application
NDA205029
Marketing category
NDA
Marketing start
2018-05-17
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-121570518-1215-0DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-121570518-1215-0DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N205029-001EPINEPHRINEEPINEPHRINE1MG/ML (1MG/ML)SOLUTION / INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUSAPRLD, RS2014-07-29
N205029-002EPINEPHRINEEPINEPHRINE10MG/10ML (1MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSAPRLD, RS2022-02-04
N205029-003EPINEPHRINEEPINEPHRINE1MG/ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2023-05-12
N205029-004EPINEPHRINEEPINEPHRINE30MG/30ML (1MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSAPRLD, RS2024-02-14
N205029-005EPINEPHRINEEPINEPHRINE1MG/ML (1MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSAPRLD, RS2024-03-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
N205029-001AP
N205029-002AP
N205029-004AP
N205029-005AP

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 4 · 128 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N205029-001EPINEPHRINE1MG/ML (1MG/ML)SOLUTION / INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUSAPRLD, RS2014-07-29caaa826d4ba7…
2026-08-18 06:07:402026-07N205029-002EPINEPHRINE10MG/10ML (1MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSAPRLD, RS2022-02-04caaa826d4ba7…
2026-08-18 06:07:402026-07N205029-003EPINEPHRINE1MG/ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2023-05-12caaa826d4ba7…
2026-08-18 06:07:402026-07N205029-004EPINEPHRINE30MG/30ML (1MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSAPRLD, RS2024-02-14caaa826d4ba7…
2026-08-18 06:07:402026-07N205029-005EPINEPHRINE1MG/ML (1MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSAPRLD, RS2024-03-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N205029-001EPINEPHRINE1MG/ML (1MG/ML)SOLUTION / INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUSAPRLD, RS2014-07-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205029-002EPINEPHRINE10MG/10ML (1MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSAPRLD, RS2022-02-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205029-003EPINEPHRINE1MG/ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2023-05-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205029-004EPINEPHRINE30MG/30ML (1MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSAPRLD, RS2024-02-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205029-005EPINEPHRINE1MG/ML (1MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSRLD, RS2024-03-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205029-001EPINEPHRINE1MG/ML (1MG/ML)SOLUTION / INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUSAPRLD, RS2014-07-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205029-002EPINEPHRINE10MG/10ML (1MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSAPRLD, RS2022-02-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205029-003EPINEPHRINE1MG/ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2023-05-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205029-004EPINEPHRINE30MG/30ML (1MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSAPRLD, RS2024-02-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205029-005EPINEPHRINE1MG/ML (1MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSRLD, RS2024-03-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08N205029-001EPINEPHRINE1MG/ML (1MG/ML)SOLUTION / INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUSAPRLD, RS2014-07-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205029-002EPINEPHRINE10MG/10ML (1MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSAPRLD, RS2022-02-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205029-003EPINEPHRINE1MG/ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2023-05-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205029-004EPINEPHRINE30MG/30ML (1MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSRLD, RS2024-02-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205029-005EPINEPHRINE1MG/ML (1MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSRLD, RS2024-03-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205029-001EPINEPHRINE1MG/ML (1MG/ML)SOLUTION / INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUSAPRLD, RS2014-07-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205029-002EPINEPHRINE10MG/10ML (1MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSAPRLD, RS2022-02-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205029-003EPINEPHRINE1MG/ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2023-05-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205029-004EPINEPHRINE30MG/30ML (1MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSRLD, RS2024-02-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205029-005EPINEPHRINE1MG/ML (1MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSRLD, RS2024-03-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205029-001EPINEPHRINE1MG/ML (1MG/ML)SOLUTION / INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUSAPRLD, RS2014-07-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205029-002EPINEPHRINE10MG/10ML (1MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSAPRLD, RS2022-02-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205029-003EPINEPHRINE1MG/ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2023-05-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205029-004EPINEPHRINE30MG/30ML (1MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSRLD, RS2024-02-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205029-005EPINEPHRINE1MG/ML (1MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSRLD, RS2024-03-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205029-001EPINEPHRINE1MG/ML (1MG/ML)SOLUTION / INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUSAPRLD, RS2014-07-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205029-002EPINEPHRINE10MG/10ML (1MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSRLD, RS2022-02-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205029-003EPINEPHRINE1MG/ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2023-05-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205029-004EPINEPHRINE30MG/30ML (1MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSRLD, RS2024-02-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205029-005EPINEPHRINE1MG/ML (1MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSRLD, RS2024-03-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205029-001EPINEPHRINE1MG/ML (1MG/ML)SOLUTION / INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUSAPRLD, RS2014-07-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205029-002EPINEPHRINE10MG/10ML (1MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSRLD, RS2022-02-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205029-003EPINEPHRINE1MG/ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2023-05-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205029-004EPINEPHRINE30MG/30ML (1MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSRLD, RS2024-02-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205029-005EPINEPHRINE1MG/ML (1MG/ML)SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSRLD, RS2024-03-042680178bc6a6…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N205029-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N205029-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N205029-004AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N205029-005AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N205029-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205029-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205029-004AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205029-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205029-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205029-004AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N205029-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205029-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205029-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205029-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205029-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205029-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205029-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205029-001AP12680178bc6a6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N205029-001AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N205029-002AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N205029-004AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N205029-005AP1a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 5 · 190 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2025-08-23 18:47 UTC2025-08N205029-001100047002034-08-14U-2325Drug product, Delist requested2018-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205029-001100397282034-08-14U-1828Delist requested2018-08-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205029-00192831972034-08-15U-1829Drug product, Delist requested2016-04-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205029-00192831972034-08-15U-1828Drug product, Delist requested2016-04-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205029-00192831972034-08-15U-1830Drug product, Delist requested2016-04-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205029-001100047002034-08-14U-2325Drug product, Delist requested2018-06-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205029-001100397282034-08-14U-1828Delist requested2018-08-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205029-00192831972034-08-15U-1829Drug product, Delist requested2016-04-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205029-00192831972034-08-15U-1828Drug product, Delist requested2016-04-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205029-00192831972034-08-15U-1830Drug product, Delist requested2016-04-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205029-001100047002034-08-14U-2325Drug product, Delist requested2018-06-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205029-001100397282034-08-14U-1828Delist requested2018-08-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205029-00192831972034-08-15U-1829Drug product, Delist requested2016-04-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205029-00192831972034-08-15U-1828Drug product, Delist requested2016-04-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205029-00192831972034-08-15U-1830Drug product, Delist requested2016-04-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205029-001100047002034-08-14U-2325Drug product, Delist requested2018-06-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205029-001100397282034-08-14U-1828Delist requested2018-08-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205029-00192831972034-08-15U-1829Drug product, Delist requested2016-04-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205029-00192831972034-08-15U-1828Drug product, Delist requested2016-04-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205029-00192831972034-08-15U-1830Drug product, Delist requested2016-04-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205029-001100047002034-08-14U-2325Drug product, Delist requested2018-06-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205029-001100397282034-08-14U-1828Delist requested2018-08-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205029-00192831972034-08-15U-1829Drug product, Delist requested2016-04-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205029-00192831972034-08-15U-1828Drug product, Delist requested2016-04-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205029-00192831972034-08-15U-1830Drug product, Delist requested2016-04-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205029-001100047002034-08-14U-2325Drug product, Delist requested2018-06-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205029-001100397282034-08-14U-1828Delist requested2018-08-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205029-00192831972034-08-15U-1829Drug product, Delist requested2016-04-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205029-00192831972034-08-15U-1828Drug product, Delist requested2016-04-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205029-00192831972034-08-15U-1830Drug product, Delist requested2016-04-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205029-001100047002034-08-14U-2325Drug product, Delist requested2018-06-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205029-001100397282034-08-14U-1828Delist requested2018-08-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205029-00192831972034-08-15U-1829Drug product, Delist requested2016-04-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205029-00192831972034-08-15U-1828Drug product, Delist requested2016-04-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205029-00192831972034-08-15U-1830Drug product, Delist requested2016-04-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N205029-001100047002034-08-14U-2325Drug product, Delist requested2018-06-29d06236e962d9…
2024-10-29 15:01 UTC2024-10N205029-001100397282034-08-14U-1828Delist requested2018-08-07d06236e962d9…
2024-10-29 15:01 UTC2024-10N205029-00192831972034-08-15U-1829Drug product, Delist requested2016-04-07d06236e962d9…
2024-10-29 15:01 UTC2024-10N205029-00192831972034-08-15U-1828Drug product, Delist requested2016-04-07d06236e962d9…
2024-10-29 15:01 UTC2024-10N205029-00192831972034-08-15U-1830Drug product, Delist requested2016-04-07d06236e962d9…

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1215EPINEPHRINE INJECTION, SOLUTION, CONCENTRATE [REMEDYREPACK INC.]12Legacy NDC20250508_a9597463-896e-4fd4-bfd5-902f6736a54d.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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EPINEPHRINEEPINEPHRINEHF Acquisition Co LLC, DBA HealthFirst5726eeca-db88-ba8e-e063-6294a90a927d2026-08-03Warnings, Adverse reactionsExact identifier
application applno (NDA): 205029
application number: NDA205029
EpinephrineEPINEPHRINEA-S Medication Solutions386519ba-7a44-4edd-9eb1-748419b7a71b2026-07-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 205029
application number: NDA205029
EPINEPHRINEEPINEPHRINEHenry Schein, Inc.af10f2bb-b0ad-45a6-b525-e715613350af2026-01-13Warnings, Adverse reactionsExact identifier
application applno (NDA): 205029
application number: NDA205029
EPINEPHRINEEPINEPHRINEBPI Labs, LLC7499cbca-b8fe-4fc3-a318-13859ab989a72025-12-26Warnings, Adverse reactionsExact identifier
application applno (NDA): 205029
application number: NDA205029
EPINEPHRINEEPINEPHRINEBPI Labs, LLC3fd8dd51-0aeb-43dd-9de0-c11b0330b15e2025-12-26Warnings, Adverse reactionsExact identifier
application applno (NDA): 205029
application number: NDA205029
EPINEPHRINEEPINEPHRINEBPI Labs, LLCdb18519b-82a9-435b-85c7-a040d644f0572025-12-26Warnings, Adverse reactionsExact identifier
application applno (NDA): 205029
application number: NDA205029
EpinephrineEPINEPHRINEBPI Labs, LLC5b5282a9-b149-4f0a-978e-5adbf48ec8aa2025-12-26Warnings, Adverse reactionsExact identifier
application applno (NDA): 205029
application number: NDA205029
EpinephrineEPINEPHRINEProPharma Distribution384445ac-0696-e367-e063-6394a90a019f2025-12-18Warnings, Adverse reactionsExact identifier
application applno (NDA): 205029
application number: NDA205029
EPINEPHRINEEPINEPHRINEMedical Purchasing Solutions, LLC.409581e7-ab70-41f3-e063-6294a90a15dc2025-10-07Warnings, Adverse reactionsExact identifier
application applno (NDA): 205029
application number: NDA205029
EPINEPHRINEEPINEPHRINEREMEDYREPACK INC.5ba14408-c8fb-4734-aad9-ee19696acac22025-09-26Warnings, Adverse reactionsExact identifier
application applno (NDA): 205029
application number: NDA205029
EpinephrineEPINEPHRINEMedical Purchasing Solutions, LLC677c33a2-4e16-406e-e053-2991aa0a45942022-10-13Warnings, Adverse reactionsExact identifier
application applno (NDA): 205029
application number: NDA205029

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1215-07051812150010 AMPULE in 1 BOX (70518-1215-0) > 1 mL in 1 AMPULE10 ampule2018-05-170000-00-00NoNoCurrent