Biting Insect Antigens

Product NDC
44911-0648
11-digit product format
449110648
Labeler code
44911
Product ID
44911-0648_0237873c-bf25-4d31-b166-ad3196948922
Type
HUMAN OTC DRUG
Nonproprietary name
Apis Mellifica, Culex Musca, Hypericum Perforatum, Ledum Palustre, Pediculus Capitis, Cimex Lectularius, Formica Rufa, Pulex Irritans, Vespa Crabro
Dosage form
LIQUID
Route
ORAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2021-10-07
Substance
APIS MELLIFERA; CIMEX LECTULARIUS; CULEX PIPIENS; FORMICA RUFA; HYPERICUM PERFORATUM WHOLE; PEDICULUS HUMANUS VAR. CAPITIS; PULEX IRRITANS WHOLE; RHODODENDRON TOMENTOSUM LEAFY TWIG; VESPA CRABRO
Active strength
12; 15; 12; 15; 12; 12; 15; 12; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Biting Insect Antigens
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
APIS MELLIFERA12 [hp_X]/mL
CIMEX LECTULARIUS15 [hp_X]/mL
CULEX PIPIENS12 [hp_X]/mL
FORMICA RUFA15 [hp_X]/mL
HYPERICUM PERFORATUM WHOLE12 [hp_X]/mL
PEDICULUS HUMANUS VAR. CAPITIS12 [hp_X]/mL
PULEX IRRITANS WHOLE15 [hp_X]/mL
RHODODENDRON TOMENTOSUM LEAFY TWIG12 [hp_X]/mL
VESPA CRABRO15 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7S82P3R43Z, W66P4K3SGW, 45KA5D7541, 55H0W83JO5, XK4IUX8MNB, 29CA62712F, L63DD62R8R, 877L01IZ0P, K3ALM8S49H

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0648-12023-11-17C16284748780-1f386c649-ba0a-0266-e053-dadaa90a7c1aDrug Facts:
44911-0648-12023-01-30C16284748780-1f386c649-ba0a-0266-e053-dadaa90a7c1aDrug Facts:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0648-1Biting Insect Antigens30 mL in 1 BOTTLE, DROPPERLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0648BITING INSECT ANTIGENS (APIS MELLIFICA, CULEX MUSCA, HYPERICUM PERFORATUM, LEDUM PALUSTRE, PEDICULUS CAPITIS, CIMEX LECTULARIUS, FORMICA RUFA, PULEX IRRITANS, VESPA CRABRO) LIQUID [ENERGIQUE, INC.]2Current NDC, Legacy NDC, 1 package rows20231118_d1241d62-d95f-45e7-84fe-2ca5bac2e0f9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0648-14491106480130 mL in 1 BOTTLE, DROPPER (44911-0648-1) 30 ml2021-10-070000-00-00NoNoCurrent