UTIBRON NEOHALER
- Product NDC
- 63402-681
- 11-digit product format
- 634020681
- Labeler code
- 63402
- Product ID
- 63402-681_53eb85fe-faf4-49ff-91db-94c158bb4f64
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- INDACATEROL MALEATE and GLYCOPYRROLATE
- Dosage form
- CAPSULE
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Sunovion Pharmaceuticals Inc.
- Application
- NDA207930
- Marketing category
- NDA
- Marketing start
- 2015-10-29
- Marketing end
- 2021-04-30
- Substance
- INDACATEROL MALEATE; GLYCOPYRROLATE
- Active strength
- 28 ug/1; ug/1
- Pharmacologic classes
- Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63402-681-06 | 63402068106 | 1 BLISTER PACK in 1 CARTON (63402-681-06) > 6 CAPSULE in 1 BLISTER PACK (63402-681-01) > 1 CAPSULE in 1 CAPSULE | 1 blister pack | 2017-12-01 | 2021-04-30 | No | No | Current |
| 63402-681-12 | 63402068112 | 2 BLISTER PACK in 1 CARTON (63402-681-12) > 6 CAPSULE in 1 BLISTER PACK (63402-681-02) > 1 CAPSULE in 1 CAPSULE | 2 blister pack | 2017-12-01 | 2021-04-30 | No | No | Current |
| 63402-681-60 | 63402068160 | 10 BLISTER PACK in 1 CARTON (63402-681-60) > 6 CAPSULE in 1 BLISTER PACK (63402-681-01) > 1 CAPSULE in 1 CAPSULE | 10 blister pack | 2017-12-01 | 2021-04-30 | No | No | Current |