Guaifenesin Extended-Release 1200 mg
- Product NDC
- 53041-234
- 11-digit product format
- 530410234
- Labeler code
- 53041
- Product ID
- 53041-234_8186c3e8-1ae5-459d-8771-ad2d1ae95387
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Guardian Drug Company
- Application
- ANDA209215
- Marketing category
- ANDA
- Marketing start
- 2018-03-01
- Substance
- GUAIFENESIN
- Active strength
- 1200 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Guaifenesin Extended-Release 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 |
|---|
| 53041-234-37 | Guaifenesin Extended-Release 1200 mg | 4 in 1 CARTON | TABLET, EXTENDED RELEASE | 4 | | 2 |
| 53041-234-37 | Guaifenesin Extended-Release 1200 mg | 7 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 7 | | 2 |
| 53041-234-47 | Guaifenesin Extended-Release 1200 mg | 7 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 7 | | 2 |
| 53041-234-47 | Guaifenesin Extended-Release 1200 mg | 6 in 1 CARTON | TABLET, EXTENDED RELEASE | 6 | | 2 |
| 53041-234-58 | Guaifenesin Extended-Release 1200 mg | 7 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 7 | | 2 |
| 53041-234-58 | Guaifenesin Extended-Release 1200 mg | 2 in 1 CARTON | TABLET, EXTENDED RELEASE | 2 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53041-234 | GUAIFENESIN EXTENDED-RELEASE 600 MG (GUAIFENESIN) TABLET, EXTENDED RELEASE GUAIFENESIN EXTENDED-RELEASE 1200 MG (GUAIFENESIN) TABLET, EXTENDED RELEASE [GUARDIAN DRUG COMPANY] | 2 | Current NDC, Legacy NDC, 6 package rows | 20180301_20f9e083-419d-429d-a570-24b312ed5d2a.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 |
|---|
| 53041-234-37 | 53041023437 | 4 BLISTER PACK in 1 CARTON (53041-234-37) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 4 blister pack | 2018-03-01 | 0000-00-00 | No | No | Current |
| 53041-234-47 | 53041023447 | 6 BLISTER PACK in 1 CARTON (53041-234-47) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 6 blister pack | 2018-03-01 | 0000-00-00 | No | No | Current |
| 53041-234-58 | 53041023458 | 2 BLISTER PACK in 1 CARTON (53041-234-58) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 2 blister pack | 2018-03-01 | 0000-00-00 | No | No | Current |