Butorphanol Tartrate

Product NDC
0143-9864
11-digit product format
001439864
Labeler code
0143
Product ID
0143-9864_b7be42f0-5b59-4a5a-a667-dfa81ff08b2a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Butorphanol Tartrate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA078400
Marketing category
ANDA
Marketing start
2009-05-01
Substance
BUTORPHANOL TARTRATE
Active strength
1 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Butorphanol Tartrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUTORPHANOL TARTRATE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2L7I72RUHN
Rxcui886627, 1728351

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
0143-9864-10Butorphanol Tartrate1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9864-10ML - Milliliter0143-986403e4489c-cc78-4fe0-9a35-b5aec6deecac12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUTORPHANOL TARTRATEACTIVE INGREDIENT2L7I72RUHNBUTORPHANOL TARTRATE INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]1
BUTORPHANOLACTIVE MOIETYQV897JC36DBUTORPHANOL TARTRATE INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9864BUTORPHANOL TARTRATE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]11Current NDC, Legacy NDC, 1 package rows20240413_bded5531-8847-4576-9a29-3e44f979d2e0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
886627butorphanol tartrate 1 MG in 1 ML InjectionPSNbded5531-8847-4576-9a29-3e44f979d2e011
1728351butorphanol tartrate 2 MG in 1 ML InjectionPSNbded5531-8847-4576-9a29-3e44f979d2e011
8866271 ML butorphanol tartrate 1 MG/ML InjectionSCDbded5531-8847-4576-9a29-3e44f979d2e011
17283511 ML butorphanol tartrate 2 MG/ML InjectionSCDbded5531-8847-4576-9a29-3e44f979d2e011
886627butorphanol tartrate 1 MG per 1 ML InjectionSYbded5531-8847-4576-9a29-3e44f979d2e011
1728351butorphanol tartrate 2 MG per 1 ML InjectionSYbded5531-8847-4576-9a29-3e44f979d2e011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9864-10001439864101 mL in 1 VIAL, SINGLE-DOSE (0143-9864-10) 1 ml2009-05-010000-00-00NoNoCurrent