Guaifenesin and pseudoephedrine hydrochloride Extended Release
- Product NDC
- 45802-230
- 11-digit product format
- 458020230
- Labeler code
- 45802
- Product ID
- 45802-230_e8f6a3e0-33c0-4f4f-b9f2-d3102039aa1a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin, pseudoephedrine hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Padagis Israel Pharmaceuticals Ltd
- Application
- ANDA091071
- Marketing category
- ANDA
- Marketing start
- 2016-01-29
- Marketing end
- 2022-02-28
- Substance
- GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 600 mg/1; mg/1
- 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 |
|---|
| 45802-230-68 | 45802023068 | 18 BLISTER PACK in 1 CARTON (45802-230-68) > 2 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 18 blister pack | 2016-01-29 | 0000-00-00 | No | No | Current |
| 45802-230-89 | 45802023089 | 18 BLISTER PACK in 1 CARTON (45802-230-89) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 18 blister pack | 2016-01-29 | 0000-00-00 | No | No | Current |