Prescription drug · ANDA
Scopolamine Trandermal System (scolopamine transdermal system) NDC 63629-8451
Scopolamine 1 mg/1 · Patch, Extended release · Transdermal · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-8451-1 | 63629845101 | 10 POUCH in 1 CARTON (63629-8451-1) / 1 PATCH, EXTENDED RELEASE in 1 POUCH (63629-8451-2)Marketed from Apr 29, 2021 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Scopolamine Trandermal System
- Generic name (nonproprietary)
- scolopamine transdermal system
- Active ingredients
- Scopolamine — 1 mg/1
- Dosage form
- Patch, Extended release
- Route
- Transdermal
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078830
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)
- Identifiers
- Product ID 63629-8451_31757cae-a379-4680-9f6e-404b57071f20SPL ID 31757cae-a379-4680-9f6e-404b57071f20SPL set ID 1099a330-fcb8-4acd-9ef8-525024c6b9d6RxCUI 226552UNII DL48G20X8X
- 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. Transdermal products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N463629845101followed by a unit qualifier and the quantityPackage 63629-8451-01. 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)
Scopolamine transdermal system is indicated in adults for prevention of: • nausea and vomiting associated with motion sickness • post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery . Scopolamine transdermal system is an anticholinergic indicated in adults for the prevention of: • nausea and vomiting associated with motion sickness. ( 1 ) • post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078830
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 |
|---|---|---|---|---|
| Scopolamine Trandermal Systemscolopamine transdermal system | Scopolamine 1 mg/1 | Patch, Extended releaseTransdermal | Bryant Ranch Prepack | 63629-8450 |
| Scopolamine Trandermal Systemscolopamine transdermal system | Scopolamine 1 mg/1 | Patch, Extended releaseTransdermal | Bryant Ranch Prepack | 63629-8452 |
| Scopolamine Trandermal Systemscolopamine transdermal system | Scopolamine 1 mg/1 | Patch, Extended releaseTransdermal | Bryant Ranch Prepack | 72162-1419 |
| Scopolamine Transdermal System | Scopolamine 1 mg/1 | Patch, Extended releaseTransdermal | Bryant Ranch Prepack | 71335-2718 |
| Scopolamine Transdermal System | Scopolamine 1 mg/1 | Patch, Extended releaseTransdermal | Padagis Israel Pharmaceuticals Ltd | 45802-580 |