Guaifenesin and Pseudoephedrine HCl
- Product NDC
- 11822-0046
- 11-digit product format
- 118220046
- Labeler code
- 11822
- Product ID
- 11822-0046_a03e6b5b-fed4-dd64-160d-be1315e7cece
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin and Pseudoephedrine HCL
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Rite Aid Corporation
- Application
- ANDA208369
- Marketing category
- ANDA
- Marketing start
- 2022-02-01
- 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 and Pseudoephedrine HCl
- 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 Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 11822-0046 | GUAIFENESIN AND PSEUDOEPHEDRINE HCL TABLET, EXTENDED RELEASE [RITE AID CORPORATION] | 3 | Current NDC, Legacy NDC | 20231011_9fb0c938-d24b-2371-95db-6c82d9511d72.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 |
|---|
| 11822-0046-1 | 11822004601 | 1 BLISTER PACK in 1 CARTON (11822-0046-1) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 1 blister pack | 2022-02-01 | 0000-00-00 | No | No | Current |
| 11822-0046-2 | 11822004602 | 2 BLISTER PACK in 1 CARTON (11822-0046-2) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 2 blister pack | 2022-02-01 | 0000-00-00 | No | No | Current |