Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
- Product NDC
- 62135-302
- 11-digit product format
- 621350302
- Labeler code
- 62135
- Product ID
- 62135-302_2501201a-b3e6-cc4d-e063-6394a90a482f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- Application
- ANDA213125
- Marketing category
- ANDA
- Marketing start
- 2020-04-17
- Substance
- BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 2; 10; 30 mg/5mL; mg/5mL; mg/5mL
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BROMPHENIRAMINE MALEATE | 2 mg/5mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/5mL |
| PSEUDOEPHEDRINE HYDROCHLORIDE | 30 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | IXA7C9ZN03, 9D2RTI9KYH, 6V9V2RYJ8N |
| Rxcui | 1357010 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62135-302-05 | Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide | 5 mL in 1 CUP | SYRUP | 5 | | 2 |
| 62135-302-24 | Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide | 2 in 1 BOX | SYRUP | 2 | | 2 |
| 62135-302-24 | Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide | 10 in 1 TRAY | SYRUP | 10 | | 2 |
| 62135-302-47 | Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide | 473 mL in 1 BOTTLE | SYRUP | 473 | | 2 |
| 62135-302-48 | Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide | 118 mL in 1 BOTTLE | SYRUP | 118 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-302 | BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [CHARTWELL RX, LLC] | 2 | Current NDC, 5 package rows | 20241023_30f0317c-4793-4b88-8c06-c0f3cb12b3ea.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 |
|---|
| 62135-302-05 | 62135030205 | 5 mL in 1 CUP | 5 ml | | | | Historical |
| 62135-302-24 | 62135030224 | 2 TRAY in 1 BOX (62135-302-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-302-05) | 2 tray | 2024-10-16 | No | No | Historical |
| 62135-302-47 | 62135030247 | 473 mL in 1 BOTTLE (62135-302-47) | 473 ml | 2023-01-23 | No | No | Historical |
| 62135-302-48 | 62135030248 | 118 mL in 1 BOTTLE (62135-302-48) | 118 ml | 2023-01-23 | No | No | Historical |