FDA.reportPublic FDA data

Olmesartan Medoxomil

Product NDC
71205-172
11-digit product format
712050172
Labeler code
71205
Product ID
71205-172_bfc9129b-05ad-4ae3-b701-73f9cc0ae9e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olmesartan Medoxomil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA204798
Marketing category
ANDA
Marketing start
2017-04-24
Substance
OLMESARTAN MEDOXOMIL
Active strength
20 mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Olmesartan Medoxomil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLMESARTAN MEDOXOMIL20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M97XTV3HD
Rxcui349401, 349405

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
caadbc51-b731-1a7b-b91a-f7bb4a62554eProduct name920240306
4a27501f-a987-48a5-99b4-e983d4744d76Product name720181211

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-172-30Olmesartan Medoxomil30 in 1 BOTTLETABLET, FILM COATED302
71205-172-60Olmesartan Medoxomil60 in 1 BOTTLETABLET, FILM COATED602
71205-172-90Olmesartan Medoxomil90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-172-30EA - Each71205-1729f1dc894-18bd-4b7d-a649-9fc445736daa12019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-172OLMESARTAN MEDOXOMIL TABLET, FILM COATED [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20191016_e210f962-9b91-46c6-af8f-9f9a9ae84245.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349401olmesartan medoxomil 20 MG Oral TabletPSNe210f962-9b91-46c6-af8f-9f9a9ae842452
349405olmesartan medoxomil 40 MG Oral TabletPSNe210f962-9b91-46c6-af8f-9f9a9ae842452
349401olmesartan medoxomil 20 MG Oral TabletSCDe210f962-9b91-46c6-af8f-9f9a9ae842452
349405olmesartan medoxomil 40 MG Oral TabletSCDe210f962-9b91-46c6-af8f-9f9a9ae842452

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-172-307120501723030 TABLET, FILM COATED in 1 BOTTLE (71205-172-30) 2018-12-010000-00-00NoNoCurrent
71205-172-607120501726060 TABLET, FILM COATED in 1 BOTTLE (71205-172-60) 2018-12-010000-00-00NoNoCurrent
71205-172-907120501729090 TABLET, FILM COATED in 1 BOTTLE (71205-172-90) 2018-12-010000-00-00NoNoCurrent