Prescription drug · ANDA
Scopolamine Trandermal System (Scolopamine transdermal system) NDC 63629-8452
Scopolamine 1 mg/1 · Patch, Extended release · Transdermal · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-8452-1 | 6362984520163629845201 | 4 POUCH in 1 CARTON (63629-8452-1) / 1 PATCH, EXTENDED RELEASE in 1 POUCH (63629-8452-2)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 PrepackNDC labeler code 63629
- 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 63629-8452_48bad7e9-60a0-4a48-8688-d8fe755426faSPL ID 48bad7e9-60a0-4a48-8688-d8fe755426faSPL set ID 81c57d46-1617-4295-8a60-acb7e365551cRxCUI 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
N463629845201followed by a unit qualifier and the quantityPackage 63629-8452-01. 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.
About NDC 63629-8452
- What is NDC 63629-8452?
- 63629-8452 is the product NDC for Scopolamine Trandermal System (scolopamine transdermal system), Scopolamine 1 mg/1 patch, extended release, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Scopolamine Trandermal System (Scolopamine transdermal system).
- What is the active ingredient?
- Scopolamine.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 63629. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Scopolamine Trandermal System?
- 3 other product NDCs are listed under this name. See all Scopolamine Trandermal System NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Scopolamine Trandermal System products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Scopolamine Trandermal Systemscolopamine transdermal system | Scopolamine 1 mg/1 | Patch, Extended releaseTransdermal | Bryant Ranch Prepack | 63629-8450 | 63629-8450-01 |
| Scopolamine Trandermal Systemscolopamine transdermal system | Scopolamine 1 mg/1 | Patch, Extended releaseTransdermal | Bryant Ranch Prepack | 63629-8451 | 63629-8451-01 |
| Scopolamine Trandermal Systemscolopamine transdermal system | Scopolamine 1 mg/1 | Patch, Extended releaseTransdermal | Bryant Ranch Prepack | 72162-1419 | 72162-1419-0272162-1419-0472162-1419-07 |
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 | 63629-8451 |
| 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 | Padagis Israel Pharmaceuticals Ltd | 45802-580 |
| Scopolamine Transdermal System | Scopolamine 1 mg/1 | Patch, Extended releaseTransdermal | Bryant Ranch Prepack | 71335-2718 |