Pyrazinamide

Product NDC
70954-484
11-digit product format
709540484
Labeler code
70954
Product ID
70954-484_e043f21d-4a30-4d23-bc03-12207af7d6d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pyrazinamide
Dosage form
TABLET
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA080157
Marketing category
ANDA
Marketing start
2021-05-11
Substance
PYRAZINAMIDE
Active strength
500 mg/1
Pharmacologic classes
Antimycobacterial [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
70954-484-10Pyrazinamide60 in 1 BOTTLETABLET602
70954-484-20Pyrazinamide90 in 1 BOTTLETABLET902
70954-484-30Pyrazinamide100 in 1 BOTTLETABLET1002
70954-484-40Pyrazinamide500 in 1 BOTTLETABLET5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70954-484-10EA - Each70954-4845aca53e7-6b0c-4841-adfc-a9f1b5a37e6012021-08-05
70954-484-20EA - Each70954-484cc040fd8-bd5e-47ac-bff1-a396a786fc6712021-08-05
70954-484-30EA - Each70954-484a829b817-b002-46e6-bfdf-039e5df91e4e12021-08-05
70954-484-40EA - Each70954-48472741e30-9761-48f6-89ae-dfe90b1a3f9f12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70954-484PYRAZINAMIDE TABLET [NOVITIUM PHARMA LLC]1Current NDC, Legacy NDC, 4 package rows20210514_262d8829-728c-48db-b89b-88d13b87e684.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
198181pyrazinamide 500 MG Oral TabletPSN262d8829-728c-48db-b89b-88d13b87e6842
198181pyrazinamide 500 MG Oral TabletPSNe2dbbdf9-ddfd-4d6d-ad42-6e658969f11e2
198181pyrazinamide 500 MG Oral TabletSCD262d8829-728c-48db-b89b-88d13b87e6842
198181pyrazinamide 500 MG Oral TabletSCDe2dbbdf9-ddfd-4d6d-ad42-6e658969f11e2
198181PZA 500 MG Oral TabletSY262d8829-728c-48db-b89b-88d13b87e6842
198181PZA 500 MG Oral TabletSYe2dbbdf9-ddfd-4d6d-ad42-6e658969f11e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70954-484-107095404841060 TABLET in 1 BOTTLE (70954-484-10) 60 tablet2021-05-110000-00-00NoNoCurrent
70954-484-207095404842090 TABLET in 1 BOTTLE (70954-484-20) 90 tablet2021-05-110000-00-00NoNoCurrent
70954-484-3070954048430100 TABLET in 1 BOTTLE (70954-484-30) 100 tablet2021-05-110000-00-00NoNoCurrent
70954-484-4070954048440500 TABLET in 1 BOTTLE (70954-484-40) 500 tablet2021-05-110000-00-00NoNoCurrent