Prescription drug · ANDA
Methscopolamine Bromide NDC 43063-741
Methscopolamine bromide 5 mg/1 · Tablet · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-741-60 | 43063074160 | 60 TABLET in 1 BOTTLE, PLASTIC (43063-741-60)Marketed from Feb 1, 2017 |
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 — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.NDC labeler code 43063
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200602
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)
- Identifiers
- Product ID 43063-741_47a742ba-d521-2942-e063-6394a90a22feSPL ID 47a742ba-d521-2942-e063-6394a90a22feSPL set ID 8a14ade6-d428-4144-9037-46955f68820fRxCUI 403914UNII RTN51LK7WLUPC 0343063741603
- 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
N443063074160followed by a unit qualifier and the quantityPackage 43063-0741-60. 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.
About NDC 43063-741
- What is NDC 43063-741?
- 43063-741 is the product NDC for Methscopolamine Bromide, Methscopolamine bromide 5 mg/1 tablet, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Methscopolamine Bromide.
- What is the active ingredient?
- Methscopolamine bromide.
- Who is the labeler?
- PD-Rx Pharmaceuticals, Inc., NDC labeler code 43063. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Methscopolamine Bromide?
- 9 other product NDCs are listed under this name. See all Methscopolamine Bromide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Methscopolamine Bromide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Methscopolamine Bromide | Methscopolamine bromide 2.5 mg/1 | TabletOral | i3 Pharmaceuticals, LLC | 72319-029 | 72319-0029-0472319-0029-06 |
| Methscopolamine Bromide | Methscopolamine bromide 5 mg/1 | TabletOral | i3 Pharmaceuticals, LLC | 72319-030 | 72319-0030-0272319-0030-06 |
| Methscopolamine Bromide | Methscopolamine bromide 5 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 76385-101 | 76385-0101-60 |
| Methscopolamine Bromide | Methscopolamine bromide 2.5 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 76385-100 | 76385-0100-01 |
| Methscopolamine Bromide | Methscopolamine bromide 2.5 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-740 | 43063-0740-01 |
| Methscopolamine Bromide | Methscopolamine bromide 2.5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2471 | 72162-2471-01 |
| Methscopolamine Bromide | Methscopolamine bromide 5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2472 | 72162-2472-06 |
| Methscopolamine Bromide | Methscopolamine bromide 5 mg/1 | TabletOral | Breckenridge Pharmaceutical, Inc. | 51991-192 | 51991-0192-0651991-0192-60 |
| Methscopolamine Bromide | Methscopolamine bromide 2.5 mg/1 | TabletOral | Breckenridge Pharmaceutical, Inc. | 51991-191 | 51991-0191-01 |
Other NDCs under ANDA 200602
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 | Unichem Pharmaceuticals (USA), Inc. | 76385-101 |
| Methscopolamine Bromide | Methscopolamine bromide 2.5 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 76385-100 |
| Methscopolamine Bromide | Methscopolamine bromide 2.5 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-740 |
| Methscopolamine Bromide | Methscopolamine bromide 2.5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2471 |
| Methscopolamine Bromide | Methscopolamine bromide 5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2472 |