Prescription drug · ANDA
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide NDC 62135-302
Brompheniramine maleate 2 mg/5mL + 2 more ingredients · Syrup · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 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)Marketed from Oct 16, 2024 | |
| 62135-302-47 | 62135030247 | 473 mL in 1 BOTTLE (62135-302-47)Marketed from Jan 23, 2023 | |
| 62135-302-48 | 62135030248 | 118 mL in 1 BOTTLE (62135-302-48)Marketed from Jan 23, 2023 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
- Generic name (nonproprietary)
- brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide
- Active ingredients
- Brompheniramine maleate — 2 mg/5mLPseudoephedrine hydrochloride — 30 mg/5mLDextromethorphan hydrobromide — 10 mg/5mL
- Dosage form
- Syrup
- Route
- Oral
- Labeler
- Chartwell RX, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213125
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 62135-302_2501201a-b3e6-cc4d-e063-6394a90a482fSPL ID 2501201a-b3e6-cc4d-e063-6394a90a482fSPL set ID 30f0317c-4793-4b88-8c06-c0f3cb12b3eaRxCUI 1357010UNII IXA7C9ZN03, 6V9V2RYJ8N, 9D2RTI9KYHUPC 0362135302481, 0362135302474
- Pharmacologic class
- Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist; alpha-Adrenergic Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N462135030224followed by a unit qualifier and the quantityPackage 62135-0302-24. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE For relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 213125
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide | Brompheniramine maleate 2 mg/5mL + 2 more ingredients | SyrupOral | Chartwell Governmental & Specialty RX, LLC | 68999-302 |