Twynsta
- Product NDC
- 0597-0125
- 11-digit product format
- 005970125
- Labeler code
- 0597
- Product ID
- 0597-0125_852d4f05-25e5-9785-0514-2826b363cf96
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- telmisartan/amlodipine
- Dosage form
- TABLET, MULTILAYER
- Route
- ORAL
- Labeler
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Application
- NDA022401
- Marketing category
- NDA
- Marketing start
- 2009-11-02
- Marketing end
- 0000-00-00
- Substance
- TELMISARTAN; AMLODIPINE BESYLATE
- Active strength
- 40 mg/1; mg/1
- Pharmacologic classes
- Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 |
|---|
| 0597-0125-37 | 00597012537 | 3 BLISTER PACK in 1 CARTON (0597-0125-37) > 10 TABLET, MULTILAYER in 1 BLISTER PACK | 3 blister pack | 2009-11-02 | 0000-00-00 | No | No | Current |