TUZISTRA XR
- Product NDC
- 69654-480
- 11-digit product format
- 696540480
- Labeler code
- 69654
- Product ID
- 69654-480_be25742c-fecb-74c4-e053-2a95a90ae5ce
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- codeine polistirex and chlorpheniramine polistirex
- Dosage form
- SUSPENSION, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Aytu BioPharma, Inc.
- Application
- NDA207768
- Marketing category
- NDA
- Marketing start
- 2015-05-31
- Marketing end
- 0000-00-00
- Substance
- CODEINE PHOSPHATE ANHYDROUS; CHLORPHENIRAMINE MALEATE
- Active strength
- 15 mg/5mL; mg/5mL
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69654-480-01 | 69654048001 | 473 mL in 1 BOTTLE (69654-480-01) | 473 ml | 2018-11-26 | 0000-00-00 | No | No | Current |
| 69654-480-02 | 69654048002 | 25 mL in 1 BOTTLE (69654-480-02) | 25 ml | 2018-11-26 | 0000-00-00 | Yes | No | Current |