FDA.reportPublic FDA data

pyrazinamide

Product NDC
0054-0812
11-digit product format
000540812
Labeler code
0054
Product ID
0054-0812_05eb3847-557f-460c-951f-e614fb9f9045
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pyrazinamide
Dosage form
TABLET
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc
Application
ANDA081319
Marketing category
ANDA
Marketing start
2024-08-30
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
0054-0812-21pyrazinamide60 in 1 CONTAINERTABLET602
0054-0812-22pyrazinamide90 in 1 CONTAINERTABLET902
0054-0812-25pyrazinamide100 in 1 CONTAINERTABLET1002
0054-0812-29pyrazinamide500 in 1 CONTAINERTABLET5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0812-21EA - Each0054-0812ed262aa6-5eac-4620-850e-56cc79f80f6712024-09-09
0054-0812-22EA - Each0054-081256d02d2b-fa47-4de7-a381-2cf9a9b9412a12024-09-09
0054-0812-25EA - Each0054-0812715e6141-0a7b-455b-8786-bd4ab5d4027912024-09-09
0054-0812-29EA - Each0054-0812c7824ffc-b7a5-4764-8598-2767dffc757b12024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-0812PYRAZINAMIDE TABLET [HIKMA PHARMACEUTICALS USA INC]2Current NDC, 4 package rows20240927_566db230-3d73-482f-b67d-defd0b2dc46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198181pyrazinamide 500 MG Oral TabletPSN566db230-3d73-482f-b67d-defd0b2dc46c2
198181pyrazinamide 500 MG Oral TabletSCD566db230-3d73-482f-b67d-defd0b2dc46c2
198181PZA 500 MG Oral TabletSY566db230-3d73-482f-b67d-defd0b2dc46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0054-0812-210005408122160 TABLET in 1 CONTAINER (0054-0812-21) 60 tablet2024-08-30NoNoHistorical
0054-0812-220005408122290 TABLET in 1 CONTAINER (0054-0812-22) 90 tablet2024-08-30NoNoHistorical
0054-0812-2500054081225100 TABLET in 1 CONTAINER (0054-0812-25) 100 tablet2024-08-30NoNoHistorical
0054-0812-2900054081229500 TABLET in 1 CONTAINER (0054-0812-29) 500 tablet2024-08-30NoNoHistorical