Hyoscyamine Sulfate ODT
- Product NDC
- 42192-338
- 11-digit product format
- 421920338
- Labeler code
- 42192
- Product ID
- 42192-338_41adc6a7-c16a-066d-e063-6394a90affc2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hyoscyamine sulfate
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Acella Pharmaceuticals, LLC
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2011-05-19
- Substance
- HYOSCYAMINE SULFATE
- Active strength
- .125 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hyoscyamine Sulfate ODT
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYOSCYAMINE SULFATE | .125 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | F2R8V82B84 |
| Rxcui | 1046985 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42192-338-01 | Hyoscyamine Sulfate ODT | 100 in 1 BOTTLE | TABLET, ORALLY DISINTEGRATING | 100 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42192-338 | HYOSCYAMINE SULFATE ODT (HYOSCYAMINE SULFATE) TABLET, ORALLY DISINTEGRATING [ACELLA PHARMACEUTICALS, LLC] | 13 | Current NDC, Legacy NDC, 1 package rows | 20241017_eef6babc-241f-40b6-b8c8-daa92bbd0a25.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 42192-338-01 | 42192033801 | 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (42192-338-01) | 2011-05-19 | 0000-00-00 | No | No | Current |