Guaifenesin 1200 mg
- Product NDC
- 43598-108
- 11-digit product format
- 435980108
- Labeler code
- 43598
- Product ID
- 43598-108_ef6a6eb4-cde7-cd56-0290-29d56beec22c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Dr. Reddy's Laboratories Inc.
- Application
- ANDA215932
- Marketing category
- ANDA
- Marketing start
- 2022-09-01
- Substance
- GUAIFENESIN
- Active strength
- 1200 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 1200 mg
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GUAIFENESIN | 1200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 495W7451VQ |
| Rxcui | 310621, 636522 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43598-108-37 | Guaifenesin 1200 mg | 14 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 14 | | 4 |
| 43598-108-37 | Guaifenesin 1200 mg | 3 in 1 CARTON | TABLET, EXTENDED RELEASE | 3 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-108 | GUAIFENESIN 600 MG (GUAIFENESIN ) TABLET, EXTENDED RELEASE GUAIFENESIN 1200 MG (GUAIFENESIN) TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20241113_525fda90-134c-f038-c403-eb5ffc1fb1f1.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 |
|---|
| 43598-108-37 | 43598010837 | 3 BLISTER PACK in 1 CARTON (43598-108-37) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 3 blister pack | 2022-09-01 | 0000-00-00 | No | No | Current |