Guaifenesin D
- Product NDC
- 70000-0580
- 11-digit product format
- 700000580
- Labeler code
- 70000
- Product ID
- 70000-0580_7c1294bf-52e9-4e14-afdf-220a15503883
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin and Pseudoephedrine Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- CARDINAL HEALTH 110, LLC. DBA LEADER
- Application
- ANDA212542
- Marketing category
- ANDA
- Marketing start
- 2021-05-06
- Marketing end
- 0000-00-00
- Substance
- GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 600 mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 |
|---|
| 70000-0580 | GUAIFENESIN D (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [CARDINAL HEALTH 110, LLC. DBA LEADER] | 5 | Legacy NDC | 20220604_3c40c30b-a7e1-470d-845a-a3d93bed9491.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70000-0580-1 | 70000058001 | 1 BLISTER PACK in 1 CARTON (70000-0580-1) > 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 1 blister pack | 2021-05-06 | 0000-00-00 | No | No | Current |
| 70000-0580-2 | 70000058002 | 2 BLISTER PACK in 1 CARTON (70000-0580-2) > 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 2 blister pack | 2021-05-06 | 0000-00-00 | No | No | Current |