Qbrexza
- Product NDC
- 69489-411
- 11-digit product format
- 694890411
- Labeler code
- 69489
- Product ID
- 69489-411_52537ea0-9410-1691-e063-6394a90a9468
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- glycopyrronium
- Dosage form
- CLOTH
- Route
- TOPICAL
- Labeler
- Journey Medical Corporation
- Application
- NDA210361
- Marketing category
- NDA
- Marketing start
- 2018-06-28
- Substance
- GLYCOPYRRONIUM TOSYLATE
- Active strength
- 2.4 g/100g
- Pharmacologic classes
- Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Qbrexza
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GLYCOPYRRONIUM TOSYLATE | 2.4 g/100g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1PVF6JLU7B |
| Rxcui | 2054118, 2054120 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69489-411-01 | Qbrexza | 2.8 g in 1 POUCH | CLOTH | 2.8 | | 5 |
| 69489-411-05 | Qbrexza | 5 in 1 CARTON | CLOTH | 5 | | 5 |
| 69489-411-30 | Qbrexza | 30 in 1 CARTON | CLOTH | 30 | | 5 |
| 69489-411-51 | Qbrexza | 2.8 g in 1 POUCH | CLOTH | 2.8 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69489-411 | QBREXZA (GLYCOPYRRONIUM) CLOTH [JOURNEY MEDICAL CORPORATION] | 4 | Current NDC, Legacy NDC, 4 package rows | 20231220_5b372650-e56e-47a5-93e2-c0c292017059.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 |
|---|
| 69489-411-01 | 69489041101 | 2.8 g in 1 POUCH | 2.8 g | | | | | Historical |
| 69489-411-05 | 69489041105 | 5 POUCH in 1 CARTON (69489-411-05) / 2.8 g in 1 POUCH (69489-411-51) | 5 pouch | 2021-12-03 | 0000-00-00 | Yes | No | Current |
| 69489-411-30 | 69489041130 | 30 POUCH in 1 CARTON (69489-411-30) / 2.8 g in 1 POUCH (69489-411-01) | 30 pouch | 2021-12-03 | 0000-00-00 | No | No | Current |
| 69489-411-50 | 69489041150 | 5 POUCH in 1 CARTON (69489-411-50) > 2.8 g in 1 POUCH (69489-411-51) | 5 pouch | 2021-12-03 | 0000-00-00 | Yes | No | Current |
| 69489-411-51 | 69489041151 | 2.8 g in 1 POUCH | 2.8 g | | | | | Historical |