Home NDC 0054-0812 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A081319-001 PYRAZINAMIDE PYRAZINAMIDE 500MG TABLET / ORAL AB RS 1992-06-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A081319-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A081319-001 PYRAZINAMIDE 500MG TABLET / ORAL AB RS 1992-06-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A081319-001 PYRAZINAMIDE 500MG TABLET / ORAL AB RS 1992-06-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A081319-001 PYRAZINAMIDE 500MG TABLET / ORAL AB RS 1992-06-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A081319-001 PYRAZINAMIDE 500MG TABLET / ORAL AB RS 1992-06-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A081319-001 PYRAZINAMIDE 500MG TABLET / ORAL AB RS 1992-06-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A081319-001 PYRAZINAMIDE 500MG TABLET / ORAL AB RS 1992-06-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A081319-001 PYRAZINAMIDE 500MG TABLET / ORAL AB RS 1992-06-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A081319-001 PYRAZINAMIDE 500MG TABLET / ORAL AB RS 1992-06-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A081319-001 PYRAZINAMIDE 500MG TABLET / ORAL AB RS 1992-06-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A081319-001 PYRAZINAMIDE 500MG TABLET / ORAL AB RS 1992-06-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A081319-001 PYRAZINAMIDE 500MG TABLET / ORAL AB RS 1992-06-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A081319-001 PYRAZINAMIDE 500MG TABLET / ORAL AB RS 1992-06-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A081319-001 PYRAZINAMIDE 500MG TABLET / ORAL AB RS 1992-06-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A081319-001 PYRAZINAMIDE 500MG TABLET / ORAL AB RS 1992-06-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A081319-001 PYRAZINAMIDE 500MG TABLET / ORAL AB RS 1992-06-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A081319-001 PYRAZINAMIDE 500MG TABLET / ORAL AB RS 1992-06-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A081319-001 PYRAZINAMIDE 500MG TABLET / ORAL AB RS 1992-06-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A081319-001 PYRAZINAMIDE 500MG TABLET / ORAL AB RS 1992-06-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A081319-001 PYRAZINAMIDE 500MG TABLET / ORAL AB 1992-06-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A081319-001 PYRAZINAMIDE 500MG TABLET / ORAL AB RS 1992-06-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A081319-001 PYRAZINAMIDE 500MG TABLET / ORAL AB RS 1992-06-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A081319-001 PYRAZINAMIDE 500MG TABLET / ORAL AB RS 1992-06-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A081319-001 PYRAZINAMIDE 500MG TABLET / ORAL AB RS 1992-06-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A081319-001 PYRAZINAMIDE 500MG TABLET / ORAL AB RS 1992-06-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A081319-001 PYRAZINAMIDE 500MG TABLET / ORAL AB RS 1992-06-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A081319-001 PYRAZINAMIDE 500MG TABLET / ORAL AB 1992-06-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A081319-001 PYRAZINAMIDE 500MG TABLET / ORAL AB 1992-06-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A081319-001 PYRAZINAMIDE 500MG TABLET / ORAL AB 1992-06-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A081319-001 PYRAZINAMIDE 500MG TABLET / ORAL AB RS 1992-06-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A081319-001 PYRAZINAMIDE 500MG TABLET / ORAL AB RS 1992-06-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A081319-001 PYRAZINAMIDE 500MG TABLET / ORAL AB RS 1992-06-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A081319-001 PYRAZINAMIDE 500MG TABLET / ORAL AB RS 1992-06-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A081319-001 PYRAZINAMIDE 500MG TABLET / ORAL AB RS 1992-06-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A081319-001 PYRAZINAMIDE 500MG TABLET / ORAL AB RS 1992-06-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A081319-001 PYRAZINAMIDE 500MG TABLET / ORAL AB RS 1992-06-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A081319-001 PYRAZINAMIDE 500MG TABLET / ORAL AB RS 1992-06-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A081319-001 PYRAZINAMIDE 500MG TABLET / ORAL AB RS 1992-06-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A081319-001 PYRAZINAMIDE 500MG TABLET / ORAL AB RS 1992-06-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A081319-001 PYRAZINAMIDE 500MG TABLET / ORAL AB RS 1992-06-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A081319-001 PYRAZINAMIDE 500MG TABLET / ORAL AB RS 1992-06-30 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base pyrazinamide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PYRAZINAMIDE 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2KNI5N06TI Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198181 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0054-0812-21 pyrazinamide 60 in 1 CONTAINER TABLET 60 2 0054-0812-22 pyrazinamide 90 in 1 CONTAINER TABLET 90 2 0054-0812-25 pyrazinamide 100 in 1 CONTAINER TABLET 100 2 0054-0812-29 pyrazinamide 500 in 1 CONTAINER TABLET 500 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-0812 PYRAZINAMIDE TABLET [HIKMA PHARMACEUTICALS USA INC] 2 Current NDC, 4 package rows 20240927_566db230-3d73-482f-b67d-defd0b2dc46c.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0054-0812-21 00054081221 60 TABLET in 1 CONTAINER (0054-0812-21) 60 tablet 2024-08-30 No No Current 0054-0812-22 00054081222 90 TABLET in 1 CONTAINER (0054-0812-22) 90 tablet 2024-08-30 No No Current 0054-0812-25 00054081225 100 TABLET in 1 CONTAINER (0054-0812-25) 100 tablet 2024-08-30 No No Current 0054-0812-29 00054081229 500 TABLET in 1 CONTAINER (0054-0812-29) 500 tablet 2024-08-30 No No Current