Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride
- Product NDC
- 61269-386
- 11-digit product format
- 612690386
- Labeler code
- 61269
- Product ID
- 61269-386_3e6cf4a3-11aa-4322-b507-8d3fff05c237
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- H2-Pharma, LLC
- Application
- NDA050786
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2025-07-01
- Substance
- BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE
- Active strength
- 140; 125; 125 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BISMUTH SUBCITRATE POTASSIUM | 140 mg/1 |
| METRONIDAZOLE | 125 mg/1 |
| TETRACYCLINE HYDROCHLORIDE | 125 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R3O80H60KX, 140QMO216E, P6R62377KV |
| Rxcui | 1294619 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 61269-386-12 | Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride | 10 in 1 BOX | CAPSULE | 10 | | 2 |
| 61269-386-12 | Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride | 12 in 1 BLISTER PACK | CAPSULE | 12 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 61269-386-12 | 61269038612 | 10 BLISTER PACK in 1 BOX (61269-386-12) / 12 CAPSULE in 1 BLISTER PACK | 10 blister pack | 2025-07-01 | No | No | Current |