TOBI Podhaler
- Product NDC
- 49502-346
- 11-digit product format
- 495020346
- Labeler code
- 49502
- Product ID
- 49502-346_d2aed563-a42a-4345-a710-c13e48b6e6ca
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tobramycin
- Dosage form
- CAPSULE
- Route
- ORAL; RESPIRATORY (INHALATION)
- Labeler
- Mylan Specialty L.P.
- Application
- NDA201688
- Marketing category
- NDA
- Marketing start
- 2020-09-24
- Marketing end
- 2023-05-31
- Substance
- TOBRAMYCIN
- Active strength
- 28 mg/1
- Pharmacologic classes
- Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
- 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 |
|---|
| 49502-346-24 | 49502034624 | 224 PACKAGE in 1 BOX, UNIT-DOSE (49502-346-24) > 56 BLISTER PACK in 1 PACKAGE > 4 CAPSULE in 1 BLISTER PACK | 224 package | 2020-09-24 | 0000-00-00 | No | No | Current |
| 49502-346-57 | 49502034657 | 7 BLISTER PACK in 1 BOX, UNIT-DOSE (49502-346-57) > 8 CAPSULE in 1 BLISTER PACK | 7 blister pack | 2021-07-23 | 0000-00-00 | Yes | No | Current |