Pylera
- Product NDC
- 58914-601
- 11-digit product format
- 589140601
- Labeler code
- 58914
- Product ID
- 58914-601_8ba040ec-d48a-45e8-a2e2-3e3b9ca7c41d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Allergan, Inc.
- Application
- NDA050786
- Marketing category
- NDA
- Marketing start
- 2013-08-01
- Marketing end
- 0000-00-00
- Substance
- BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE
- Active strength
- 140 mg/1; mg/1; mg/1
- Pharmacologic classes
- Bismuth [CS], Bismuth [EPC], Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS], Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 |
|---|
| 58914-601-20 | 58914060120 | 1 BLISTER PACK in 1 BOX (58914-601-20) > 120 CAPSULE in 1 BLISTER PACK | 1 blister pack | 2013-08-01 | 0000-00-00 | No | No | Current |
| 58914-601-21 | 58914060121 | 1 BOTTLE in 1 BOX (58914-601-21) > 120 CAPSULE in 1 BOTTLE | 1 bottle | 2013-08-01 | 0000-00-00 | No | No | Current |