GILTUSS DIABETIC DM
- Product NDC
- 58552-149
- 11-digit product format
- 585520149
- Labeler code
- 58552
- Product ID
- 58552-149_40b94d7e-722e-6dce-e063-6394a90a2e10
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan HBr
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Gil Pharmaceutical Corp
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-08-09
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE
- Active strength
- 30 mg/10mL
- Pharmacologic classes
- Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- GILTUSS DIABETIC DM
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 30 mg/10mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9D2RTI9KYH |
| Rxcui | 1090496 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58552-149-04 | GILTUSS DIABETIC DM | 1 in 1 CARTON | SOLUTION | 1 | | 4 |
| 58552-149-04 | GILTUSS DIABETIC DM | 118 mL in 1 BOTTLE | SOLUTION | 118 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58552-149 | GILTUSS DIABETIC DM (DEXTROMETHORPHAN HBR) SOLUTION [GIL PHARMACEUTICAL CORP] | 3 | Current NDC, 2 package rows | 20241027_bd367ce1-996b-45bc-865e-b6aafe0ea7b0.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 |
|---|
| 58552-149-04 | 58552014904 | 1 BOTTLE in 1 CARTON (58552-149-04) / 118 mL in 1 BOTTLE | 1 bottle | 2023-08-09 | No | No | Historical |