FDA.reportPublic FDA data

Butorphanol Tartrate

Product NDC
60505-0813
11-digit product format
605050813
Labeler code
60505
Product ID
60505-0813_88ae38c6-790d-dafe-6cef-646b84e274ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Butorphanol Tartrate
Dosage form
SPRAY
Route
NASAL
Labeler
Apotex Corp.
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
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 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
60505-0813-1Butorphanol Tartrate2.5 mL in 1 BOTTLE, SPRAYSPRAY2.523
60505-0813-1Butorphanol Tartrate1 in 1 CONTAINERSPRAY123

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0813-1ML - Milliliter60505-0813f6ab76b8-abe7-4c3d-a9c1-26329f32b18512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUTORPHANOL TARTRATEACTIVE INGREDIENT2L7I72RUHNBUTORPHANOL TARTRATE (BUTORPHANOL TARTRATE ) SOLUTION [APOTEX CORP.]1
ButorphanolACTIVE MOIETYQV897JC36DBUTORPHANOL TARTRATE (BUTORPHANOL TARTRATE ) SOLUTION [APOTEX CORP.]1
benzethonium chlorideINACTIVE INGREDIENTPH41D05744BUTORPHANOL TARTRATE (BUTORPHANOL TARTRATE ) SOLUTION [APOTEX CORP.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPBUTORPHANOL TARTRATE (BUTORPHANOL TARTRATE ) SOLUTION [APOTEX CORP.]1
hydrochloric acidINACTIVE INGREDIENTQTT17582CBBUTORPHANOL TARTRATE (BUTORPHANOL TARTRATE ) SOLUTION [APOTEX CORP.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XBUTORPHANOL TARTRATE (BUTORPHANOL TARTRATE ) SOLUTION [APOTEX CORP.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IBUTORPHANOL TARTRATE (BUTORPHANOL TARTRATE ) SOLUTION [APOTEX CORP.]1
WATERINACTIVE INGREDIENT059QF0KO0RBUTORPHANOL TARTRATE (BUTORPHANOL TARTRATE ) SOLUTION [APOTEX CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0813BUTORPHANOL TARTRATE (BUTORPHANOL TARTRATE ) SPRAY [APOTEX CORP.]18Current NDC, Legacy NDC, 2 package rows20240118_b8e48063-0b40-ee43-85c1-4ef2de80c404.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
886634butorphanol tartrate 10 MG/mL Metered Dose Nasal SprayPSNb8e48063-0b40-ee43-85c1-4ef2de80c40423
886634butorphanol tartrate 1 MG/ACTUAT Metered Dose Nasal SpraySCDb8e48063-0b40-ee43-85c1-4ef2de80c40423

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-0813-1605050813011 BOTTLE, SPRAY in 1 CONTAINER (60505-0813-1) / 2.5 mL in 1 BOTTLE, SPRAY2002-12-040000-00-00NoNoCurrent