PYRAZINAMIDE

Product NDC
10135-735
11-digit product format
101350735
Labeler code
10135
Product ID
10135-735_45222685-8d74-a7e1-e063-6294a90a9945
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pyrazinamide tablet
Dosage form
TABLET
Route
ORAL
Labeler
MARLEX PHARMACEUTICALS, INC
Application
ANDA080157
Marketing category
ANDA
Marketing start
2022-03-01
Substance
PYRAZINAMIDE
Active strength
500 mg/1
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
PYRAZINAMIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRAZINAMIDE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2KNI5N06TI
Rxcui198181

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
74627275-f344-a42f-8f8b-d6190f614e0eProduct name220210211
7cf7f62d-3767-728f-c117-96e96c1ed8bfProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-735-01PYRAZINAMIDE100 in 1 BOTTLETABLET1005
10135-735-60PYRAZINAMIDE60 in 1 BOTTLETABLET605
10135-735-90PYRAZINAMIDE90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-735-01EA - Each10135-735e1eb469b-0ad2-4d7c-b2e3-f965d0d640c912022-04-06
10135-735-60EA - Each10135-73507438a09-dcfa-4c1b-965f-ccb3d26d9ae112022-04-06
10135-735-90EA - Each10135-735250bd172-db7b-4429-aef9-940f1bed1db812022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-735PYRAZINAMIDE (PYRAZINAMIDE TABLET) TABLET [MARLEX PHARMACEUTICALS, INC]3Current NDC, Legacy NDC, 3 package rows20241018_db250a85-2e20-87e9-e053-2a95a90a72b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198181pyrazinamide 500 MG Oral TabletPSNdb250a85-2e20-87e9-e053-2a95a90a72b65
198181pyrazinamide 500 MG Oral TabletSCDdb250a85-2e20-87e9-e053-2a95a90a72b65
198181PZA 500 MG Oral TabletSYdb250a85-2e20-87e9-e053-2a95a90a72b65

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10135-735-0110135073501100 TABLET in 1 BOTTLE (10135-735-01) 100 tablet2022-03-010000-00-00NoNoCurrent
10135-735-601013507356060 TABLET in 1 BOTTLE (10135-735-60) 60 tablet2022-03-010000-00-00NoNoCurrent
10135-735-901013507359090 TABLET in 1 BOTTLE (10135-735-90) 90 tablet2022-03-010000-00-00NoNoCurrent