Isoniazid

Product NDC
46287-009
11-digit product format
462870009
Labeler code
46287
Product ID
46287-009_b4455fa7-39e3-41a5-9a5b-5ff7c490de89
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
isoniazid
Dosage form
SOLUTION
Route
ORAL
Labeler
CMP Pharma, Inc.
Application
ANDA088235
Marketing category
ANDA
Marketing start
1983-11-11
Substance
ISONIAZID
Active strength
50 mg/5mL
Pharmacologic classes
Antimycobacterial [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISONIAZID50 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV83O1VOZ8L
Rxcui105292

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46287-009-01Isoniazid473 mL in 1 BOTTLESOLUTION4736

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46287-009-01ML - Milliliter46287-0093bf86d71-3865-43fb-abf2-0e9f3b416c9c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISONIAZIDACTIVE INGREDIENTV83O1VOZ8LISONIAZID SOLUTION [CAROLINA MEDICAL PRODUCTS COMPANY]3
ISONIAZIDACTIVE MOIETYV83O1VOZ8LISONIAZID SOLUTION [CAROLINA MEDICAL PRODUCTS COMPANY]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPISONIAZID SOLUTION [CAROLINA MEDICAL PRODUCTS COMPANY]3
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4ISONIAZID SOLUTION [CAROLINA MEDICAL PRODUCTS COMPANY]3
SORBITOLINACTIVE INGREDIENT506T60A25RISONIAZID SOLUTION [CAROLINA MEDICAL PRODUCTS COMPANY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46287-009ISONIAZID SOLUTION [CMP PHARMA, INC.]6Current NDC, Legacy NDC, 1 package rows20241116_db8a3ae7-fb5b-47a9-a9f7-f57cd90501c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
105292isoniazid 50 MG in 5 mL Oral SolutionPSNfada0e39-68f7-434d-91fc-84a67fc940f910
105292isoniazid 10 MG/ML Oral SolutionSCDfada0e39-68f7-434d-91fc-84a67fc940f910
105292INH 10 MG/ML Oral SolutionSYfada0e39-68f7-434d-91fc-84a67fc940f910
105292isoniazid 50 MG per 5 ML Oral SolutionSYfada0e39-68f7-434d-91fc-84a67fc940f910
105292isoniazid 50 MG per 5 ML SyrupSYfada0e39-68f7-434d-91fc-84a67fc940f910
105292isoniazid 50 MG in 5 mL Oral SolutionPSNdb8a3ae7-fb5b-47a9-a9f7-f57cd90501c26
105292isoniazid 10 MG/ML Oral SolutionSCDdb8a3ae7-fb5b-47a9-a9f7-f57cd90501c26
105292INH 10 MG/ML Oral SolutionSYdb8a3ae7-fb5b-47a9-a9f7-f57cd90501c26
105292isoniazid 50 MG per 5 ML Oral SolutionSYdb8a3ae7-fb5b-47a9-a9f7-f57cd90501c26
105292isoniazid 50 MG per 5 ML SyrupSYdb8a3ae7-fb5b-47a9-a9f7-f57cd90501c26
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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46287-009-0146287000901473 mL in 1 BOTTLE (46287-009-01) 473 ml1983-11-110000-00-00NoNoCurrent