Norepinephrine Phenolic

Product NDC
44911-0499
11-digit product format
449110499
Labeler code
44911
Product ID
44911-0499_caf1ecb8-e75e-45b0-a007-99de2afc618e
Type
HUMAN OTC DRUG
Nonproprietary name
Norepinephrine (Bitartrate)
Dosage form
LIQUID
Route
ORAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-06-07
Substance
NOREPINEPHRINE BITARTRATE
Active strength
6 [hp_X]/mL
Pharmacologic classes
Catecholamine [EPC], Catecholamines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage44911-0499-11332a3947898…d4bfe170f9cd…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage44911-0499-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage44911-0499-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage44911-0499-18dfbde2a14a4…c9ff85d89658…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NOREPINEPHRINE BITARTRATE6 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
IFY5PE3ZRWInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c5e6dda9-32c5-42f8-b302-b69ddbdb5011Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2ab36713-99a4-1d04-c42f-907afc73b6f9Product name720260105
209a4db0-2639-413d-9ad3-274ad7be11f7Product name120230912
08ddeef6-6d79-428b-a00b-432b50fc2b32Product name120230831

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-03-26DRUG FACTS:
2024-01-30DRUG FACTS:
2022-04-13DRUG FACTS:
2021-01-29DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0499-1Norepinephrine Phenolic30 mL in 1 BOTTLE, DROPPERLIQUID304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0499NOREPINEPHRINE PHENOLIC (NOREPINEPHRINE (BITARTRATE)) LIQUID [ENERGIQUE, INC.]4Current NDC, Legacy NDC, 1 package rows20240328_c5e6dda9-32c5-42f8-b302-b69ddbdb5011.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Norepinephrine PhenolicNOREPINEPHRINE (BITARTRATE)Energique, Inc.c5e6dda9-32c5-42f8-b302-b69ddbdb50112024-03-26WarningsExact identifier
ndc (product): 44911-0499

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0499-14491104990130 mL in 1 BOTTLE, DROPPER (44911-0499-1) 30 ml2019-06-070000-00-00NoNoCurrent