FDA.reportPublic FDA data

Butorphanol Tartrate

Product NDC
72162-2099
11-digit product format
721622099
Labeler code
72162
Product ID
72162-2099_2ed74d4d-331d-4663-9dfd-1e87ea1a3a78
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Butorphanol Tartrate
Dosage form
SPRAY
Route
NASAL
Labeler
Bryant Ranch Prepack
Application
ANDA075499
Marketing category
ANDA
Marketing start
2002-12-04
Substance
BUTORPHANOL TARTRATE
Active strength
10 mg/mL
Pharmacologic classes
Competitive Opioid Antagonists [MoA], Opioid Agonist/Antagonist [EPC], Partial Opioid Agonists [MoA]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUTORPHANOL TARTRATE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2L7I72RUHN
Rxcui886634

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
acf6c143-7e17-30a4-779f-24d002b44752Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2099-2Butorphanol Tartrate2.5 mL in 1 BOTTLE, SPRAYSPRAY2.5102
72162-2099-2Butorphanol Tartrate1 in 1 CONTAINERSPRAY1102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2099-2ML - Milliliter72162-20990f3ef7ab-72cf-484a-a615-e3d3c348d6a812023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2099BUTORPHANOL TARTRATE (BUTORPHANOL TARTRATE ) SPRAY [BRYANT RANCH PREPACK]101Current NDC, 2 package rows20240418_412499ce-db93-4943-ae1a-564c27b1fb16.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
886634butorphanol tartrate 10 MG/mL Metered Dose Nasal SprayPSN412499ce-db93-4943-ae1a-564c27b1fb16102
886634butorphanol tartrate 1 MG/ACTUAT Metered Dose Nasal SpraySCD412499ce-db93-4943-ae1a-564c27b1fb16102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2099-2721622099021 BOTTLE, SPRAY in 1 CONTAINER (72162-2099-2) / 2.5 mL in 1 BOTTLE, SPRAY2023-09-19NoNoCurrent