Prescription drug · ANDA
Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride NDC 49884-151
Bismuth subcitrate potassium 140 mg/1 + 2 more ingredients · Capsule · Oral · Par Health USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49884-151-54 | 4988401515449884015154 | 120 CAPSULE in 1 CARTON (49884-151-54)Marketed from Mar 7, 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 and Tetracycline Hydrochloride
- Generic name (nonproprietary)
- bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride
- Active ingredients
- Bismuth subcitrate potassium — 140 mg/1Metronidazole — 125 mg/1Tetracycline hydrochloride — 125 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Par Health USA, LLCNDC labeler code 49884
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205770
- Marketing start
- Listing expires
- Other FDA classes
- Bismuth (Chemical structure)Nitroimidazoles (Chemical structure)Tetracyclines (Chemical structure)
- Identifiers
- Product ID 49884-151_1ba717f8-b210-40c9-a16e-85edbddaba02SPL ID 1ba717f8-b210-40c9-a16e-85edbddaba02SPL set ID c4d66e80-f0bc-4e64-a0f0-630ef673da1bRxCUI 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
N449884015154followed by a unit qualifier and the quantityPackage 49884-0151-54. 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 capsules are 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, metronida…
Excerpt only. Read the full label for complete information.
About NDC 49884-151
- What is NDC 49884-151?
- 49884-151 is the product NDC for Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride, Bismuth subcitrate potassium 140 mg/1 + 2 more ingredients capsule, listed with the FDA by Par Health USA, 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 and Tetracycline Hydrochloride.
- What is the active ingredient?
- Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride.
- Who is the labeler?
- Par Health USA, LLC, NDC labeler code 49884. 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 and Tetracycline Hydrochloride?
- 1 other product NDC are listed under this name. See all Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride | Bismuth subcitrate potassium 140 mg/1 + 2 more ingredients | CapsuleOral | H2-Pharma, LLC | 61269-386 | 61269-0386-12 |