Home NDC 0039-0222-10 AMARYL
Product NDC 0039-0222
Requested package NDC 0039-0222-10
11-digit product format 000390222
Labeler code 0039
Product ID 0039-0222_f54571bb-4a69-4326-aad3-96b1b7198b6d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name glimepiride
Dosage form TABLET
Route ORAL
Labeler Sanofi-Aventis U.S. LLC
Application NDA020496
Marketing category NDA
Marketing start 2009-06-18
Marketing end 0000-00-00
Substance GLIMEPIRIDE
Active strength 2 mg/1
Pharmacologic classes Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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Approval date N020496-001 AMARYL GLIMEPIRIDE 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-11-30 N020496-002 AMARYL GLIMEPIRIDE 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-11-30 N020496-003 AMARYL GLIMEPIRIDE 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-11-30
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 4 · 123 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 2026-02-19 14:30 UTC 2026-02 N020496-001 AMARYL 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-11-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020496-002 AMARYL 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-11-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020496-003 AMARYL 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-11-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020496-001 AMARYL 1MG TABLET / ORAL RLD 1995-11-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020496-002 AMARYL 2MG TABLET / ORAL RLD 1995-11-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020496-003 AMARYL 4MG TABLET / ORAL RLD 1995-11-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020496-001 AMARYL 1MG TABLET / ORAL RLD 1995-11-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020496-002 AMARYL 2MG TABLET / ORAL RLD 1995-11-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020496-003 AMARYL 4MG TABLET / ORAL RLD 1995-11-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020496-001 AMARYL 1MG TABLET / ORAL RLD 1995-11-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020496-002 AMARYL 2MG TABLET / ORAL RLD 1995-11-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020496-003 AMARYL 4MG TABLET / ORAL RLD 1995-11-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020496-001 AMARYL 1MG TABLET / ORAL AB RLD, RS 1995-11-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020496-002 AMARYL 2MG TABLET / ORAL AB RLD 1995-11-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020496-003 AMARYL 4MG TABLET / ORAL AB RLD 1995-11-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020496-001 AMARYL 1MG TABLET / ORAL AB RLD, RS 1995-11-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020496-002 AMARYL 2MG TABLET / ORAL AB RLD 1995-11-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020496-003 AMARYL 4MG TABLET / ORAL AB RLD 1995-11-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020496-001 AMARYL 1MG TABLET / ORAL AB RLD, RS 1995-11-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020496-002 AMARYL 2MG TABLET / ORAL AB RLD 1995-11-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020496-003 AMARYL 4MG TABLET / ORAL AB RLD 1995-11-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020496-001 AMARYL 1MG TABLET / ORAL AB RLD, RS 1995-11-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020496-002 AMARYL 2MG TABLET / ORAL AB RLD 1995-11-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020496-003 AMARYL 4MG TABLET / ORAL AB RLD 1995-11-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020496-001 AMARYL 1MG TABLET / ORAL AB RLD, RS 1995-11-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020496-002 AMARYL 2MG TABLET / ORAL AB RLD 1995-11-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020496-003 AMARYL 4MG TABLET / ORAL AB RLD 1995-11-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020496-001 AMARYL 1MG TABLET / ORAL AB RLD, RS 1995-11-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020496-002 AMARYL 2MG TABLET / ORAL AB RLD 1995-11-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020496-003 AMARYL 4MG TABLET / ORAL AB RLD 1995-11-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020496-001 AMARYL 1MG TABLET / ORAL AB RLD, RS 1995-11-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020496-002 AMARYL 2MG TABLET / ORAL AB RLD 1995-11-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020496-003 AMARYL 4MG TABLET / ORAL AB RLD 1995-11-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020496-001 AMARYL 1MG TABLET / ORAL AB RLD, RS 1995-11-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020496-002 AMARYL 2MG TABLET / ORAL AB RLD 1995-11-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020496-003 AMARYL 4MG TABLET / ORAL AB RLD 1995-11-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020496-001 AMARYL 1MG TABLET / ORAL AB RLD, RS 1995-11-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020496-002 AMARYL 2MG TABLET / ORAL AB RLD 1995-11-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020496-003 AMARYL 4MG TABLET / ORAL AB RLD 1995-11-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020496-001 AMARYL 1MG TABLET / ORAL AB RLD, RS 1995-11-30 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 108 observed states.
DailyMed Socrata Ingredients# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0039-0222-10 00039022210 100 TABLET in 1 BOTTLE (0039-0222-10) 100 tablet 2009-06-18 0000-00-00 No No Current