Guaifenesin Extended Release
- Product NDC
- 45802-325
- 11-digit product format
- 458020325
- Labeler code
- 45802
- Product ID
- 45802-325_e42f38aa-e1d5-4b41-8ab6-4ea03960b0b9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Padagis Israel Pharmaceuticals Ltd
- Application
- ANDA091009
- Marketing category
- ANDA
- Marketing start
- 2016-01-25
- Marketing end
- 2021-12-31
- Substance
- GUAIFENESIN
- Active strength
- 1200 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 |
|---|
| 45802-325-30 | 45802032530 | 1 BOTTLE in 1 CARTON (45802-325-30) > 28 TABLET, EXTENDED RELEASE in 1 BOTTLE | 1 bottle | 2016-01-25 | 0000-00-00 | No | No | Current |
| 45802-325-66 | 45802032566 | 1 BOTTLE in 1 CARTON (45802-325-66) > 14 TABLET, EXTENDED RELEASE in 1 BOTTLE | 1 bottle | 2016-03-16 | 2021-12-31 | No | No | Current |