Guaifenesin and pseudoephedrine hydrochloride Extended Release
- Product NDC
- 63187-960
- 11-digit product format
- 631870960
- Labeler code
- 63187
- Product ID
- 63187-960_474280cc-828d-4cfc-96ae-08a47e64d320
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin, pseudoephedrine hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA091071
- Marketing category
- ANDA
- Marketing start
- 2016-01-29
- Marketing end
- 0000-00-00
- Substance
- GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 600 mg/1; mg/1
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-960 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED RELEASE (GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PROFICIENT RX LP] | 3 | Legacy NDC | 20191105_a4a9f535-3674-450c-b84b-b65ca1654cfb.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63187-960-18 | 63187096018 | 18 BLISTER PACK in 1 CARTON (63187-960-18) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 18 blister pack | 2018-01-01 | 0000-00-00 | No | No | Current |