Guaifenesin D
- Product NDC
- 0363-9930
- 11-digit product format
- 003639930
- Labeler code
- 0363
- Product ID
- 0363-9930_a170c33d-402e-447f-ad46-402c60045461
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin and Pseudoephedrine Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Walgreen Company
- Application
- ANDA212542
- Marketing category
- ANDA
- Marketing start
- 2021-05-06
- Substance
- GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 600; 60 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 D
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GUAIFENESIN | 600 mg/1 |
| PSEUDOEPHEDRINE HYDROCHLORIDE | 60 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 495W7451VQ, 6V9V2RYJ8N |
| Rxcui | 1305603 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0363-9930-18 | Guaifenesin D | 18 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 18 | | 4 |
| 0363-9930-18 | Guaifenesin D | 1 in 1 CARTON | TABLET, EXTENDED RELEASE | 1 | | 4 |
| 0363-9930-36 | Guaifenesin D | 18 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 18 | | 4 |
| 0363-9930-36 | Guaifenesin D | 2 in 1 CARTON | TABLET, EXTENDED RELEASE | 2 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0363-9930 | GUAIFENESIN D (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [WALGREEN COMPANY] | 4 | Current NDC, Legacy NDC, 4 package rows | 20220819_abecb791-b635-482f-bb99-3ee4b7093e78.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0363-9930-18 | 00363993018 | 1 BLISTER PACK in 1 CARTON (0363-9930-18) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 1 blister pack | 2021-05-06 | 0000-00-00 | No | No | Current |
| 0363-9930-36 | 00363993036 | 2 BLISTER PACK in 1 CARTON (0363-9930-36) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 2 blister pack | 2021-05-06 | 0000-00-00 | No | No | Current |