OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
- Product NDC
- 16729-368
- 11-digit product format
- 167290368
- Labeler code
- 16729
- Product ID
- 16729-368_424dfa88-8ad1-1ec4-e063-6394a90a8dcf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Accord Healthcare Inc.
- Application
- ANDA209281
- Marketing category
- ANDA
- Marketing start
- 2020-09-03
- Substance
- HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
- Active strength
- 25; 40 mg/1; mg/1
- Pharmacologic classes
- Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
- 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 AND HYDROCHLOROTHIAZIDE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCHLOROTHIAZIDE | 25 mg/1 |
| OLMESARTAN MEDOXOMIL | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6M97XTV3HD, 0J48LPH2TH |
| Rxcui | 403853, 403854, 403855 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16729-368-10 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 7 |
| 16729-368-15 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 7 |
| 16729-368-16 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 7 |
| 16729-368-17 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 7 |
| 16729-368-45 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 7 |
| 16729-368-46 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 100 in 1 CARTON | TABLET, FILM COATED | 100 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16729-368 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.] | 6 | Current NDC, Legacy NDC, 6 package rows | 20241006_d858a6de-dda5-4bcd-a255-5723d01d896f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 16729-368-10 | 16729036810 | 30 in 1 BOTTLE | | | | | Historical |
| 16729-368-15 | 16729036815 | 90 TABLET, FILM COATED in 1 BOTTLE (16729-368-15) | 2020-09-03 | 0000-00-00 | No | No | Current |
| 16729-368-16 | 16729036816 | 500 in 1 BOTTLE | | | | | Historical |
| 16729-368-17 | 16729036817 | 1000 in 1 BOTTLE | | | | | Historical |
| 16729-368-45 | 16729036845 | 10 in 1 BLISTER PACK | | | | | Historical |
| 16729-368-46 | 16729036846 | 100 in 1 CARTON | | | | | Historical |