Home NDC 68382-643 olmesartan medoxomil
Product NDC 68382-643
11-digit product format 683820643
Labeler code 68382
Product ID 68382-643_0fb52f36-690a-4321-a374-345bfacf74b0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name olmesartan medoxomil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA205192
Marketing category ANDA
Marketing start 2017-04-24
Marketing end 0000-00-00
Substance OLMESARTAN MEDOXOMIL
Active strength 5 mg/1
Pharmacologic classes Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 14 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A205192-001 OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 A205192-002 OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 A205192-003 OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24
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 4 · 132 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 2026-10-15 13:18:30 2026-09 A205192-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 A205192-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 A205192-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 c2088c7a36db…2026-09-14 22:38:34 2026-08 A205192-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205192-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205192-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A205192-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205192-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205192-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205192-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205192-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205192-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205192-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205192-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205192-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205192-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205192-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205192-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205192-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205192-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205192-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205192-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205192-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205192-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205192-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205192-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205192-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205192-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205192-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205192-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205192-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205192-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205192-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205192-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205192-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205192-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205192-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205192-002 OLMESARTAN MEDOXOMIL 20MG TABLET / ORAL AB 2017-04-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205192-003 OLMESARTAN MEDOXOMIL 40MG TABLET / ORAL AB 2017-04-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205192-001 OLMESARTAN MEDOXOMIL 5MG TABLET / ORAL AB 2017-04-24 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 4 of 4 · 132 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68382-643-01 68382064301 100 TABLET, FILM COATED in 1 BOTTLE (68382-643-01) 2017-04-24 0000-00-00 No No Current 68382-643-05 68382064305 500 TABLET, FILM COATED in 1 BOTTLE (68382-643-05) 2017-04-24 0000-00-00 No No Current 68382-643-06 68382064306 30 TABLET, FILM COATED in 1 BOTTLE (68382-643-06) 2017-04-24 0000-00-00 No No Current 68382-643-10 68382064310 1000 TABLET, FILM COATED in 1 BOTTLE (68382-643-10) 2017-04-24 0000-00-00 No No Current 68382-643-16 68382064316 90 TABLET, FILM COATED in 1 BOTTLE (68382-643-16) 2017-04-24 0000-00-00 No No Current 68382-643-77 68382064377 10 BLISTER PACK in 1 CARTON (68382-643-77) > 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-643-30) 10 blister pack 2017-04-24 0000-00-00 No No Current