Isoniazid

Product NDC
55695-031
11-digit product format
556950031
Labeler code
55695
Product ID
55695-031_2dcb1a5f-a1dd-3686-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
isoniazid
Dosage form
SOLUTION
Route
ORAL
Labeler
Department of State Health Services, Pharmacy Branch
Application
ANDA088235
Marketing category
ANDA
Marketing start
1983-11-11
Marketing end
0000-00-00
Substance
ISONIAZID
Active strength
50 mg/5mL
Pharmacologic classes
Antimycobacterial [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0c158ae5-31fa-5bc4-3cf2-0aa120f1417dProduct name120140508
26abd97e-907b-0cb8-84ee-99fb15297adaProduct name120140508
7cf7f62d-3767-728f-c117-96e96c1ed8bfProduct name120140508
9e3dea0d-7fd5-1a7e-e095-3b9e72f40538Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55695-031-002020-01-31C16284748780-19d75b9cf-db95-f424-e053-dadaa90a57ceISONIAZID ORAL SOLUTION, USP 50 mg/5 mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55695-031-00Isoniazid473 mL in 1 BOTTLESOLUTION4735

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55695-031ISONIAZID SOLUTION [DEPARTMENT OF STATE HEALTH SERVICES, PHARMACY BRANCH]5Legacy NDC, 1 package rows20160311_9461d512-bbb4-4e2f-86f8-6df58cd21a8a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
105292isoniazid 50 MG in 5 mL Oral SolutionPSN9461d512-bbb4-4e2f-86f8-6df58cd21a8a5
105292isoniazid 10 MG/ML Oral SolutionSCD9461d512-bbb4-4e2f-86f8-6df58cd21a8a5
105292INH 10 MG/ML Oral SolutionSY9461d512-bbb4-4e2f-86f8-6df58cd21a8a5
105292isoniazid 50 MG per 5 ML Oral SolutionSY9461d512-bbb4-4e2f-86f8-6df58cd21a8a5
105292isoniazid 50 MG per 5 ML SyrupSY9461d512-bbb4-4e2f-86f8-6df58cd21a8a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
55695-031-0055695003100473 mL in 1 BOTTLE473 mlHistorical