Prescription drug · ANDA
Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride NDC 50742-283
Bismuth subcitrate potassium 140 mg/1 + 2 more ingredients · Capsule · Oral · Ingenus Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50742-283-13 | 5074202831350742028313 | 120 CAPSULE in 1 CARTON (50742-283-13)Marketed from Jul 4, 2023 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride
- Generic name (nonproprietary)
- bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride
- Active ingredients
- Bismuth subcitrate potassium — 140 mg/1Metronidazole — 125 mg/1Tetracycline hydrochloride — 125 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Ingenus Pharmaceuticals, LLCNDC labeler code 50742
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217511
- Marketing start
- Listing expires
- Other FDA classes
- Bismuth (Chemical structure)Nitroimidazoles (Chemical structure)Tetracyclines (Chemical structure)
- Identifiers
- Product ID 50742-283_6842c7a1-52e9-4047-81e1-22da3ec35505SPL ID 6842c7a1-52e9-4047-81e1-22da3ec35505SPL set ID 4c7f024d-ba26-43cf-a36f-597e2168cd9fRxCUI 1294619UNII R3O80H60KX, 140QMO216E, P6R62377KV
- Pharmacologic class
- Bismuth; Nitroimidazole Antimicrobial; Tetracycline-class Antimicrobial
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N450742028313followed by a unit qualifier and the quantityPackage 50742-0283-13. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsule is a combination of metronidazole, a nitroimidazole antimicrobial, tetracycline, - a tetracycline class antimicrobial and bismuth subcitrate potassium, indicated for use, in combination with omeprazole, for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori. ( 1.1 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules and other antibacterial drugs, bismuth subcitrate potassium, metronidazo…
Excerpt only. Read the full label for complete information.
About NDC 50742-283
- What is NDC 50742-283?
- 50742-283 is the product NDC for Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride, Bismuth subcitrate potassium 140 mg/1 + 2 more ingredients capsule, listed with the FDA by Ingenus Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride.
- What is the active ingredient?
- Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride.
- Who is the labeler?
- Ingenus Pharmaceuticals, LLC, NDC labeler code 50742. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.