Home NDC 70199-016-05 Zyloprim
Product NDC 70199-016
Requested package NDC 70199-016-05
11-digit product format 701990016
Labeler code 70199
Product ID 70199-016_c014e234-aeb6-4ada-ae8b-97791ff3c923
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name allopurinol
Dosage form TABLET
Route ORAL
Labeler Casper Pharma LLC
Application NDA016084
Marketing category NDA
Marketing start 2018-08-06
Marketing end 0000-00-00
Substance ALLOPURINOL
Active strength 300 mg/1
Pharmacologic classes Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N016084-001 ZYLOPRIM ALLOPURINOL 100MG TABLET / ORAL AB RLD, Approved before 1982 N016084-002 ZYLOPRIM ALLOPURINOL 300MG TABLET / ORAL AB RLD, Approved before 1982 N016084-003 ZYLOPRIM ALLOPURINOL 200MG TABLET / ORAL AB RLD 2022-08-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 3 · 112 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 N016084-001 ZYLOPRIM 100MG TABLET / ORAL AB RLD, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N016084-002 ZYLOPRIM 300MG TABLET / ORAL AB RLD, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N016084-003 ZYLOPRIM 200MG TABLET / ORAL AB RLD 2022-08-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N016084-001 ZYLOPRIM 100MG TABLET / ORAL AB RLD, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N016084-002 ZYLOPRIM 300MG TABLET / ORAL AB RLD, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N016084-003 ZYLOPRIM 200MG TABLET / ORAL AB RLD 2022-08-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N016084-001 ZYLOPRIM 100MG TABLET / ORAL AB RLD, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N016084-002 ZYLOPRIM 300MG TABLET / ORAL AB RLD, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N016084-003 ZYLOPRIM 200MG TABLET / ORAL AB RLD 2022-08-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N016084-001 ZYLOPRIM 100MG TABLET / ORAL AB RLD, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N016084-002 ZYLOPRIM 300MG TABLET / ORAL AB RLD, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N016084-003 ZYLOPRIM 200MG TABLET / ORAL AB RLD 2022-08-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N016084-001 ZYLOPRIM 100MG TABLET / ORAL AB RLD, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N016084-002 ZYLOPRIM 300MG TABLET / ORAL AB RLD, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N016084-003 ZYLOPRIM 200MG TABLET / ORAL AB RLD 2022-08-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N016084-001 ZYLOPRIM 100MG TABLET / ORAL AB RLD, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N016084-002 ZYLOPRIM 300MG TABLET / ORAL AB RLD, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N016084-003 ZYLOPRIM 200MG TABLET / ORAL AB RLD 2022-08-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N016084-001 ZYLOPRIM 100MG TABLET / ORAL AB RLD, Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N016084-002 ZYLOPRIM 300MG TABLET / ORAL AB RLD, Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N016084-003 ZYLOPRIM 200MG TABLET / ORAL AB RLD 2022-08-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N016084-001 ZYLOPRIM 100MG TABLET / ORAL AB RLD, Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N016084-002 ZYLOPRIM 300MG TABLET / ORAL AB RLD, Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N016084-003 ZYLOPRIM 200MG TABLET / ORAL AB RLD 2022-08-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N016084-001 ZYLOPRIM 100MG TABLET / ORAL AB RLD, Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N016084-002 ZYLOPRIM 300MG TABLET / ORAL AB RLD, Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N016084-003 ZYLOPRIM 200MG TABLET / ORAL AB RLD 2022-08-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N016084-001 ZYLOPRIM 100MG TABLET / ORAL AB RLD, Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N016084-002 ZYLOPRIM 300MG TABLET / ORAL AB RLD, Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N016084-003 ZYLOPRIM 200MG TABLET / ORAL AB RLD 2022-08-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N016084-001 ZYLOPRIM 100MG TABLET / ORAL AB RLD, Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N016084-002 ZYLOPRIM 300MG TABLET / ORAL AB RLD, Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N016084-003 ZYLOPRIM 200MG TABLET / ORAL AB RLD 2022-08-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N016084-001 ZYLOPRIM 100MG TABLET / ORAL AB RLD, Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N016084-002 ZYLOPRIM 300MG TABLET / ORAL AB RLD, Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N016084-003 ZYLOPRIM 200MG TABLET / ORAL AB RLD 2022-08-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N016084-001 ZYLOPRIM 100MG TABLET / ORAL AB RLD, Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N016084-002 ZYLOPRIM 300MG TABLET / ORAL AB RLD, Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N016084-003 ZYLOPRIM 200MG TABLET / ORAL AB RLD 2022-08-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N016084-001 ZYLOPRIM 100MG TABLET / ORAL AB RLD, Approved before 1982 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 98 observed states.
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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70199-016-05 70199001605 500 TABLET in 1 BOTTLE (70199-016-05) 500 tablet 2018-08-06 0000-00-00 No No Current