Guaifenesin
- Product NDC
- 58602-864
- 11-digit product format
- 586020864
- Labeler code
- 58602
- Product ID
- 58602-864_ceb62dda-680c-4f3d-8bcf-6245344a1146
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Aurohealth LLC
- Application
- ANDA210453
- Marketing category
- ANDA
- Marketing start
- 2021-03-11
- Substance
- GUAIFENESIN
- Active strength
- 600 mg/1
- Pharmacologic classes
- Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Guaifenesin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GUAIFENESIN | 600 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 495W7451VQ |
| Rxcui | 636522 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58602-864-98 | Guaifenesin | 5 in 1 CARTON | TABLET, EXTENDED RELEASE | 5 | | 4 |
| 58602-864-98 | Guaifenesin | 20 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 20 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58602-864 | GUAIFENESIN TABLET, EXTENDED RELEASE [AUROHEALTH LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20231202_30c27274-a051-4884-b41e-12943d92b199.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 |
|---|
| 58602-864-98 | 58602086498 | 5 BLISTER PACK in 1 CARTON (58602-864-98) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 5 blister pack | 2021-03-11 | 0000-00-00 | No | No | Current |