FDA.reportPublic FDA data

Gablofen

Product NDC
66794-151
11-digit product format
667940151
Labeler code
66794
Product ID
66794-151_5135dfce-e3c4-a382-e063-6394a90a4875
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen Injection
Dosage form
INJECTION, SOLUTION
Route
INTRATHECAL
Labeler
Piramal Critical Care Inc
Application
NDA022462
Marketing category
NDA
Marketing start
2017-04-01
Substance
BACLOFEN
Active strength
50 ug/mL
Pharmacologic classes
GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACLOFEN50 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH789N3FKE8
Rxcui308517, 1047437, 1047440, 1047444, 1300890, 1301627, 1369783, 1369784, 1369787, 1369788, 1369791, 1369792, 1666613, 1666615

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e25d01b-2e92-4765-bec7-8a0fd7bdc346Product name220251208
1b1393e5-f2d8-42f5-a070-e3416d619667Product name120250804
88583480-702d-4dfe-a31c-9c00abd818f8Product name720250729
1cf3c538-592e-4b4b-869e-51d4bf3ca83dProduct name220240703
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
6e532d1f-e0b5-46eb-a2be-d70bd338df9dProduct name120220613
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
ef6bc0bf-8134-f06b-70d9-4980df6f808eProduct name520210615
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
eeec0918-7a2f-44bf-83d6-1216e507adbfProduct name320191217
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
a5300adb-f538-4abb-a49e-f8f0b8d9ac75Product name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66794-151-01Gablofen1 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION143

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66794-151-01ML - Milliliter66794-15134e6b8ae-05d7-45c3-8217-6f927915fbfb12017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66794-151GABLOFEN (BACLOFEN INJECTION) INJECTION, SOLUTION [PIRAMAL CRITICAL CARE INC]40Current NDC, Legacy NDC, 1 package rows20250524_00d3e846-dd92-448d-9ab8-6a07be823cc1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308517baclofen 10 MG in 20 ML (500 MCG/ML) InjectionPSN00d3e846-dd92-448d-9ab8-6a07be823cc143
1369783baclofen 10,000 MCG in 20 ML (500 MCG/ML) Prefilled SyringePSN00d3e846-dd92-448d-9ab8-6a07be823cc143
1300890baclofen 20,000 MCG in 20 ML (1,000 MCG/ML) InjectionPSN00d3e846-dd92-448d-9ab8-6a07be823cc143
1369787baclofen 20,000 MCG in 20 ML (1,000 MCG/ML) Prefilled SyringePSN00d3e846-dd92-448d-9ab8-6a07be823cc143
1666613baclofen 40 MG in 20 ML (2,000 MCG/ML) InjectionPSN00d3e846-dd92-448d-9ab8-6a07be823cc143
1369791baclofen 40,000 MCG in 20 ML (2,000 MCG/ML) Prefilled SyringePSN00d3e846-dd92-448d-9ab8-6a07be823cc143
1047437baclofen 50 MCG in 1 ML Prefilled SyringePSN00d3e846-dd92-448d-9ab8-6a07be823cc143
1047444Gablofen 10,000 MCG in 20 ML (500 MCG/ML) InjectionPSN00d3e846-dd92-448d-9ab8-6a07be823cc143
1369784Gablofen 10,000 MCG in 20 ML (500 MCG/ML) Prefilled SyringePSN00d3e846-dd92-448d-9ab8-6a07be823cc143
1301627Gablofen 20,000 MCG in 20 ML (1,000 MCG/ML) InjectionPSN00d3e846-dd92-448d-9ab8-6a07be823cc143
1369788Gablofen 20,000 MCG in 20 ML (1,000 MCG/ML) Prefilled SyringePSN00d3e846-dd92-448d-9ab8-6a07be823cc143
1666615Gablofen 40,000 MCG in 20 ML (2,000 MCG/ML) InjectionPSN00d3e846-dd92-448d-9ab8-6a07be823cc143
1369792Gablofen 40,000 MCG in 20 ML (2,000 MCG/ML) Prefilled SyringePSN00d3e846-dd92-448d-9ab8-6a07be823cc143
1047440Gablofen 50 MCG in 1 ML Prefilled SyringePSN00d3e846-dd92-448d-9ab8-6a07be823cc143
10474401 ML baclofen 0.05 MG/ML Prefilled Syringe [Gablofen]SBD00d3e846-dd92-448d-9ab8-6a07be823cc143
104744420 ML baclofen 0.5 MG/ML Injection [Gablofen]SBD00d3e846-dd92-448d-9ab8-6a07be823cc143
136978420 ML baclofen 0.5 MG/ML Prefilled Syringe [Gablofen]SBD00d3e846-dd92-448d-9ab8-6a07be823cc143
130162720 ML baclofen 1 MG/ML Injection [Gablofen]SBD00d3e846-dd92-448d-9ab8-6a07be823cc143
136978820 ML baclofen 1 MG/ML Prefilled Syringe [Gablofen]SBD00d3e846-dd92-448d-9ab8-6a07be823cc143
166661520 ML baclofen 2 MG/ML Injection [Gablofen]SBD00d3e846-dd92-448d-9ab8-6a07be823cc143
136979220 ML baclofen 2 MG/ML Prefilled Syringe [Gablofen]SBD00d3e846-dd92-448d-9ab8-6a07be823cc143
10474371 ML baclofen 0.05 MG/ML Prefilled SyringeSCD00d3e846-dd92-448d-9ab8-6a07be823cc143
30851720 ML baclofen 0.5 MG/ML InjectionSCD00d3e846-dd92-448d-9ab8-6a07be823cc143
136978320 ML baclofen 0.5 MG/ML Prefilled SyringeSCD00d3e846-dd92-448d-9ab8-6a07be823cc143
130089020 ML baclofen 1 MG/ML InjectionSCD00d3e846-dd92-448d-9ab8-6a07be823cc143
136978720 ML baclofen 1 MG/ML Prefilled SyringeSCD00d3e846-dd92-448d-9ab8-6a07be823cc143
166661320 ML baclofen 2 MG/ML InjectionSCD00d3e846-dd92-448d-9ab8-6a07be823cc143
136979120 ML baclofen 2 MG/ML Prefilled SyringeSCD00d3e846-dd92-448d-9ab8-6a07be823cc143
10474401 ML Gablofen 0.05 MG/ML Prefilled SyringeSY00d3e846-dd92-448d-9ab8-6a07be823cc143
104744420 ML Gablofen 0.5 MG/ML InjectionSY00d3e846-dd92-448d-9ab8-6a07be823cc143
136978420 ML Gablofen 0.5 MG/ML Prefilled SyringeSY00d3e846-dd92-448d-9ab8-6a07be823cc143
130162720 ML Gablofen 1 MG/ML InjectionSY00d3e846-dd92-448d-9ab8-6a07be823cc143
136978820 ML Gablofen 1 MG/ML Prefilled SyringeSY00d3e846-dd92-448d-9ab8-6a07be823cc143
166661520 ML Gablofen 2 MG/ML InjectionSY00d3e846-dd92-448d-9ab8-6a07be823cc143
136979220 ML Gablofen 2 MG/ML Prefilled SyringeSY00d3e846-dd92-448d-9ab8-6a07be823cc143
308517baclofen 10,000 MCG per 20 ML InjectionSY00d3e846-dd92-448d-9ab8-6a07be823cc143
1369783baclofen 10,000 MCG per 20 ML Prefilled SyringeSY00d3e846-dd92-448d-9ab8-6a07be823cc143
1369791baclofen 2 MG/ML 20 ML Prefilled SyringeSY00d3e846-dd92-448d-9ab8-6a07be823cc143
1300890baclofen 20,000 MCG per 20 ML InjectionSY00d3e846-dd92-448d-9ab8-6a07be823cc143
1369787baclofen 20,000 MCG per 20 ML Prefilled SyringeSY00d3e846-dd92-448d-9ab8-6a07be823cc143
1666613baclofen 40,000 MCG per 20 ML InjectionSY00d3e846-dd92-448d-9ab8-6a07be823cc143
1369791baclofen 40,000 MCG per 20 ML Prefilled SyringeSY00d3e846-dd92-448d-9ab8-6a07be823cc143
1047437baclofen 50 MCG per 1 ML Prefilled SyringeSY00d3e846-dd92-448d-9ab8-6a07be823cc143
1047444Gablofen 10,000 MCG per 20 ML InjectionSY00d3e846-dd92-448d-9ab8-6a07be823cc143
1369784Gablofen 10,000 MCG per 20 ML Prefilled SyringeSY00d3e846-dd92-448d-9ab8-6a07be823cc143
1369792Gablofen 2 MG/ML 20 ML Prefilled SyringeSY00d3e846-dd92-448d-9ab8-6a07be823cc143
1301627Gablofen 20,000 MCG per 20 ML InjectionSY00d3e846-dd92-448d-9ab8-6a07be823cc143
1369788Gablofen 20,000 MCG per 20 ML Prefilled SyringeSY00d3e846-dd92-448d-9ab8-6a07be823cc143
1666615Gablofen 40,000 MCG per 20 ML InjectionSY00d3e846-dd92-448d-9ab8-6a07be823cc143
1369792Gablofen 40,000 mcg per 20 ML Prefilled SyringeSY00d3e846-dd92-448d-9ab8-6a07be823cc143
1047440Gablofen 50 MCG per 1 ML Prefilled SyringeSY00d3e846-dd92-448d-9ab8-6a07be823cc143
1047444Gablofen 500 MCG per 1 ML InjectionSY00d3e846-dd92-448d-9ab8-6a07be823cc143

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66794-151-01667940151011 mL in 1 SYRINGE, GLASS (66794-151-01) 1 ml2017-04-010000-00-00NoNoCurrent