Scopolamine Trandermal System
- Product NDC
- 63629-8452
- 11-digit product format
- 636298452
- Labeler code
- 63629
- Product ID
- 63629-8452_48bad7e9-60a0-4a48-8688-d8fe755426fa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- scolopamine transdermal system
- Dosage form
- PATCH, EXTENDED RELEASE
- Route
- TRANSDERMAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA078830
- Marketing category
- ANDA
- Marketing start
- 2017-06-13
- Substance
- SCOPOLAMINE
- Active strength
- 1 mg/1
- Pharmacologic classes
- Anticholinergic [EPC], Cholinergic Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Scopolamine Trandermal System
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SCOPOLAMINE | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | DL48G20X8X |
| Rxcui | 226552 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63629-8452-1 | Scopolamine Trandermal System | 4 in 1 CARTON | PATCH, EXTENDED RELEASE | 4 | | 106 |
| 63629-8452-2 | Scopolamine Trandermal System | 1 in 1 POUCH | PATCH, EXTENDED RELEASE | 1 | | 106 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-8452 | SCOPOLAMINE TRANDERMAL SYSTEM (SCOLOPAMINE TRANSDERMAL SYSTEM) PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK] | 106 | Current NDC, Legacy NDC, 2 package rows | 20250315_81c57d46-1617-4295-8a60-acb7e365551c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-8452-1 | 63629845201 | 4 POUCH in 1 CARTON (63629-8452-1) / 1 PATCH, EXTENDED RELEASE in 1 POUCH (63629-8452-2) | 4 pouch | 2021-04-29 | 0000-00-00 | No | No | Current |
| 63629-8452-2 | 63629845202 | 1 in 1 POUCH | | | | | | Historical |