OTIPRIO
- Product NDC
- 0268-8200
- 11-digit product format
- 002688200
- Labeler code
- 0268
- Product ID
- 0268-8200_3ff889ae-1127-46ac-a1cc-13c1e38840f3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- OTIPRIO
- Dosage form
- SUSPENSION
- Route
- INTRATYMPANIC
- Labeler
- ALK-Abello, Inc.
- Application
- NDA207986
- Marketing category
- NDA
- Marketing start
- 2022-04-04
- Marketing end
- 2022-12-31
- Substance
- CIPROFLOXACIN
- Active strength
- 60 mg/mL
- Pharmacologic classes
- Quinolone Antimicrobial [EPC], Quinolones [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 | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0268-8200-01 | 00268820001 | 1 VIAL, SINGLE-USE in 1 CARTON (0268-8200-01) > 1 mL in 1 VIAL, SINGLE-USE | 2022-04-04 | 2022-12-31 | No | No | Current |