Dextromethorphan hydrobromide and quinidine sulfate
- Product NDC
- 31722-693
- 11-digit product format
- 317220693
- Labeler code
- 31722
- Product ID
- 31722-693_2d3a1851-0309-c3a1-e063-6294a90abd14
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dextromethorphan hydrobromide and quinidine sulfate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA218426
- Marketing category
- ANDA
- Marketing start
- 2024-08-28
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE
- Active strength
- 20; 10 mg/1; mg/1
- Pharmacologic classes
- Antiarrhythmic [EPC], Cytochrome P450 2D6 Inhibitor [EPC], Cytochrome P450 2D6 Inhibitors [MoA], 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
- Dextromethorphan hydrobromide and quinidine sulfate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/1 |
| QUINIDINE SULFATE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9D2RTI9KYH, J13S2394HE |
| Rxcui | 1040054 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 31722-693-60 | Dextromethorphan hydrobromide and quinidine sulfate | 60 in 1 BOTTLE | CAPSULE | 60 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-693 | DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE (DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE) CAPSULE [CAMBER PHARMACEUTICALS, INC.] | 1 | Current NDC, 1 package rows | 20250205_7028dcb7-f436-4cf6-9beb-23c1d215c798.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 |
|---|
| 31722-693-60 | 31722069360 | 60 CAPSULE in 1 BOTTLE (31722-693-60) | 60 capsule | 2024-08-28 | No | No | Current |