Crcle Guaifensin Extended Release Tablet, 1200 mg
- Product NDC
- 57483-280
- 11-digit product format
- 574830280
- Labeler code
- 57483
- Product ID
- 57483-280_77d8fc95-d94b-42f5-97ae-b5ff59ef638b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifensin Extended-Release
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Innovus Pharmaceuticals, Inc.
- Application
- ANDA213420
- Marketing category
- ANDA
- Marketing start
- 2020-09-10
- 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
- Crcle Guaifensin Extended Release Tablet, 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 |
|---|
| 57483-280-02 | Crcle Guaifensin Extended Release Tablet, 1200 mg | 14 in 1 BLISTER PACK | TABLET | 14 | | 1 |
| 57483-280-02 | Crcle Guaifensin Extended Release Tablet, 1200 mg | 4 in 1 CARTON | TABLET | 4 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57483-280 | CRCLE GUAIFENESIN EXTENDED-RELEASE TABLETS, 600 MG (GUAIFENESIN EXTENDED-RELEASE) TABLET CRCLE GUAIFENSIN EXTENDED RELEASE TABLET, 1200 MG (GUAIFENSIN EXTENDED-RELEASE) TABLET [INNOVUS PHARMACEUTICALS, INC.] | 1 | Current NDC, 2 package rows | 20230523_bba4b91a-bea9-41be-9588-5fb1483c7d10.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 |
|---|
| 57483-280-02 | 57483028002 | 4 BLISTER PACK in 1 CARTON (57483-280-02) / 14 TABLET in 1 BLISTER PACK | 4 blister pack | 2023-04-28 | No | No | Historical |