Guaifenesin and Pseudoephedrine HCl
- Product NDC
- 62207-828
- 11-digit product format
- 622070828
- Labeler code
- 62207
- Product ID
- 62207-828_44f2a33c-21a2-28a8-e063-6294a90a50ab
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin and Pseudoephedrine HCl
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Granules India Ltd
- Application
- ANDA216082
- Marketing category
- ANDA
- Marketing start
- 2023-06-01
- Substance
- GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 1200; 120 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Guaifenesin and Pseudoephedrine HCl
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GUAIFENESIN | 1200 mg/1 |
| PSEUDOEPHEDRINE HYDROCHLORIDE | 120 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 495W7451VQ, 6V9V2RYJ8N |
| Rxcui | 1244675, 1305603 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62207-828-71 | Guaifenesin and Pseudoephedrine HCl | 7 in 1 CARTON | TABLET, EXTENDED RELEASE | 7 | | 4 |
| 62207-828-71 | Guaifenesin and Pseudoephedrine HCl | 10 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 10 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62207-828 | GUAIFENESIN AND PSEUDOEPHEDRINE HCL TABLET, EXTENDED RELEASE [GRANULES INDIA LTD] | 3 | Current NDC, 2 package rows | 20241019_75f4ff44-02e7-4a23-a394-85fe8b442e1a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 62207-828-71 | 62207082871 | 7 BLISTER PACK in 1 CARTON (62207-828-71) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 7 blister pack | 2023-06-01 | No | No | Current |