FDA.reportPublic FDA data

Gablofen

Product NDC
66794-157
Requested package NDC
66794-157-02
11-digit product format
667940157
Labeler code
66794
Product ID
66794-157_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
2000 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022462-001GABLOFENBACLOFEN0.05MG/MLINJECTABLE / INTRATHECALAPRLD, RS2010-11-19
N022462-002GABLOFENBACLOFEN0.5MG/MLINJECTABLE / INTRATHECALAPRLD, RS2010-11-19
N022462-003GABLOFENBACLOFEN2MG/MLINJECTABLE / INTRATHECALAPRLD, RS2010-11-19
N022462-004GABLOFENBACLOFEN1MG/MLINJECTABLE / INTRATHECALAPRLD, RS2012-06-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
N022462-001AP
N022462-002AP
N022462-003AP
N022462-004AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N022462-001GABLOFEN0.05MG/MLINJECTABLE / INTRATHECALAPRLD, RS2010-11-19a50c72e98297…
2026-08-01 22:54:322026-06N022462-002GABLOFEN0.5MG/MLINJECTABLE / INTRATHECALAPRLD, RS2010-11-19a50c72e98297…
2026-08-01 22:54:322026-06N022462-003GABLOFEN2MG/MLINJECTABLE / INTRATHECALAPRLD, RS2010-11-19a50c72e98297…
2026-08-01 22:54:322026-06N022462-004GABLOFEN1MG/MLINJECTABLE / INTRATHECALAPRLD, RS2012-06-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N022462-001AP1a50c72e98297…
2026-08-01 22:54:322026-06N022462-002AP1a50c72e98297…
2026-08-01 22:54:322026-06N022462-003AP1a50c72e98297…
2026-08-01 22:54:322026-06N022462-004AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GablofenBACLOFEN INJECTIONPiramal Critical Care Inc00d3e846-dd92-448d-9ab8-6a07be823cc12026-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 022462
application number: NDA022462
ndc (package): 66794-157-02
ndc (product): 66794-157
ndc11 (package): 66794015702

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACLOFEN2000 ug/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
H789N3FKE8Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 14 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308517Internal RxNorm lookup
1047437Internal RxNorm lookup
1047440Internal RxNorm lookup
1047444Internal RxNorm lookup
1300890Internal RxNorm lookup
1301627Internal RxNorm lookup
1369783Internal RxNorm lookup
1369784Internal RxNorm lookup
1369787Internal RxNorm lookup
1369788Internal RxNorm lookup
1369791Internal RxNorm lookup
1369792Internal RxNorm lookup
1666613Internal RxNorm lookup
1666615Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
00d3e846-dd92-448d-9ab8-6a07be823cc1Available on FDA.report

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
66794-157-01Gablofen20 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION2043
66794-157-02Gablofen20 mL in 1 VIAL, GLASSINJECTION, SOLUTION2043

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66794-157-01ML - Milliliter66794-1573536c90c-62dd-4477-b768-51fae7d86e2912018-01-12
66794-157-02ML - Milliliter66794-1575d76a2d9-aa10-4818-a6aa-508432d8381112018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66794-157GABLOFEN (BACLOFEN INJECTION) INJECTION, SOLUTION [PIRAMAL CRITICAL CARE INC]40Current NDC, Legacy NDC, 2 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
66794-157-026679401570220 mL in 1 VIAL, GLASS (66794-157-02) 20 ml2017-04-010000-00-00NoNoCurrent