telmisartan and hydrochlorothiazide
- Product NDC
- 0054-0546
- 11-digit product format
- 000540546
- Labeler code
- 0054
- Product ID
- 0054-0546_426556da-fe30-4161-9845-e1a7dfbeafda
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- telmisartan and hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- NDA021162
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2014-02-28
- Marketing end
- 2022-07-31
- Substance
- TELMISARTAN; HYDROCHLOROTHIAZIDE
- Active strength
- 80 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
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0054-0546-18 | 00054054618 | 3 BLISTER PACK in 1 CARTON (0054-0546-18) > 10 TABLET in 1 BLISTER PACK | 3 blister pack | 2014-02-28 | 0000-00-00 | No | No | Current |