DARTISLA ODT
- Product NDC
- 82111-518
- 11-digit product format
- 821110518
- Labeler code
- 82111
- Product ID
- 82111-518_b7fa57f9-9e30-4011-8e80-d2e5699d5b6a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glycopyrrolate Orally Disintegrating Tablets
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Edenbridge Pharmaceuticals LLC.
- Application
- NDA215019
- Marketing category
- NDA
- Marketing start
- 2022-02-01
- Marketing end
- 0000-00-00
- Substance
- GLYCOPYRROLATE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Anticholinergic [EPC], Cholinergic Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82111-518 | DARTISLA ODT (GLYCOPYRROLATE ORALLY DISINTEGRATING TABLETS) TABLET, ORALLY DISINTEGRATING [EDENBRIDGE PHARMACEUTICALS LLC.] | 5 | Legacy NDC | 20231025_52daf47e-7ba3-4105-be7f-27001a87e16e.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 82111-518-01 | 82111051801 | 3 BLISTER PACK in 1 CARTON (82111-518-01) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 3 blister pack | 2022-02-01 | 0000-00-00 | No | No | Current |