Prescription drug · ANDA
Methscopolamine Bromide NDC 72319-029
Methscopolamine bromide 2.5 mg/1 · Tablet · Oral · i3 Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72319-029-04 | 72319002904 | 100 TABLET in 1 BOTTLE (72319-029-04)Marketed from Dec 18, 2024 | |
| 72319-029-06 | 72319002906 | 1000 TABLET in 1 BOTTLE (72319-029-06)Marketed from Dec 18, 2024 |
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)
- Methscopolamine Bromide
- Generic name (nonproprietary)
- methscopolamine bromide
- Active ingredients
- Methscopolamine bromide — 2.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- i3 Pharmaceuticals, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216786
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)
- Identifiers
- Product ID 72319-029_2ee941f2-7d8c-dd6e-e063-6394a90a0db9SPL ID 2ee941f2-7d8c-dd6e-e063-6394a90a0db9SPL set ID 14c0c030-e96d-4a5e-95ff-02dd78a46be3RxCUI 314088, 403914UNII RTN51LK7WL
- Pharmacologic class
- Anticholinergic
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
N472319002904followed by a unit qualifier and the quantityPackage 72319-0029-04. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Adjunctive therapy for the treatment of peptic ulcer. METHSCOPOLAMINE BROMIDE HAS NOT BEEN SHOWN TO BE EFFECTIVE IN CONTRIBUTING TO THE HEALING OF PEPTIC ULCER, DECREASING THE RATE OF RECURRENCE OR PREVENTING COMPLICATIONS.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216786
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Methscopolamine Bromide | Methscopolamine bromide 5 mg/1 | TabletOral | i3 Pharmaceuticals, LLC | 72319-030 |