Prescription drug · ANDA
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution NDC 68071-3551
Dextromethorphan hydrobromide 15 mg/5mL; Promethazine hydrochloride 6.25 mg/5mL · Solution · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-3551-4 | 6807135510468071355104 | 118 mL in 1 BOTTLE (68071-3551-4)Marketed from Dec 1, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution
- Generic name (nonproprietary)
- promethazine hydrochloride and dextromethorphan hydrobromide oral solution
- Active ingredients
- Dextromethorphan hydrobromide — 15 mg/5mLPromethazine hydrochloride — 6.25 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals,Inc.NDC labeler code 68071
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040649
- Marketing start
- Listing expires
- Other FDA classes
- Phenothiazines (Chemical structure)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 68071-3551_2d3fb2d4-6352-3f26-e063-6294a90a0163SPL ID 2d3fb2d4-6352-3f26-e063-6294a90a0163SPL set ID 0b7bfbab-decb-970c-e063-6394a90a50efRxCUI 991528UNII 9D2RTI9KYH, R61ZEH7I1IUPC 0368071355147
- Pharmacologic class
- Phenothiazine; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist
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
N468071355104followed by a unit qualifier and the quantityPackage 68071-3551-04. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Promethazine hydrochloride and dextromethorphan hydrobromide oral solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.
Excerpt only. Read the full label for complete information.
About NDC 68071-3551
- What is NDC 68071-3551?
- 68071-3551 is the product NDC for Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution, Dextromethorphan hydrobromide 15 mg/5mL; Promethazine hydrochloride 6.25 mg/5mL solution, listed with the FDA by NuCare Pharmaceuticals,Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution.
- What is the active ingredient?
- Dextromethorphan hydrobromide, Promethazine hydrochloride.
- Who is the labeler?
- NuCare Pharmaceuticals,Inc., NDC labeler code 68071. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution?
- 16 other product NDCs are listed under this name. See all Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | Promethazine hydrochloride 6.25 mg/5mL; Dextromethorphan hydrobromide 15 mg/5mL | SolutionOral | Advagen Pharma Ltd | 72888-038 | 72888-0038-0172888-0038-02 |
| Promethazine Hydrochloride And Dextromethorphan Hydrobromide | Promethazine hydrochloride 6.25 mg/5mL; Dextromethorphan hydrobromide 15 mg/5mL | SolutionOral | Camber Pharmaceuticals, Inc. | 31722-692 | 31722-0692-1131722-0692-47 |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | Promethazine hydrochloride 6.25 mg/5mL; Dextromethorphan hydrobromide 15 mg/5mL | SolutionOral | Cosette Pharmaceuticals, Inc. | 0713-0780 | 00713-0780-75 |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | Promethazine hydrochloride 6.25 mg/5mL; Dextromethorphan hydrobromide 15 mg/5mL | SyrupOral | Xttrium Laboratories, Inc | 0116-4024 | 00116-4024-16 |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | Promethazine hydrochloride 6.25 mg/5mL; Dextromethorphan hydrobromide 15 mg/5mL | SyrupOral | Atlantic Biologicals Corp. | 17856-4024 | 17856-4024-01 |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | Promethazine hydrochloride 6.25 mg/5mL; Dextromethorphan hydrobromide 15 mg/5mL | SyrupOral | A-S Medication Solutions | 50090-7658 | 50090-7658-0050090-7658-01 |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | Promethazine hydrochloride 6.25 mg/5mL; Dextromethorphan hydrobromide 15 mg/5mL | SolutionOral | Asclemed USA, Inc. | 76420-335 | 76420-0335-0476420-0335-16 |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | Promethazine hydrochloride 6.25 mg/5mL; Dextromethorphan hydrobromide 15 mg/5mL | SolutionOral | ANI Pharmaceuticals, Inc. | 62559-758 | 62559-0758-0462559-0758-16 |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution | Dextromethorphan hydrobromide 15 mg/5mL; Promethazine hydrochloride 6.25 mg/5mL | SolutionOral | ATLANTIC BIOLOGICALS CORP. | 17856-0155 | 17856-0155-01 |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral | Dextromethorphan hydrobromide 15 mg/5mL; Promethazine hydrochloride 6.25 mg/5mL | SolutionOral | A-S Medication Solutions | 50090-6585 | 50090-6585-00 |
All 17 Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution NDCs
Other NDCs under ANDA 040649
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 |
|---|---|---|---|---|
| Promethazine DMpromethazine hydrochloride and dextromethorphan hydrobromide | Dextromethorphan hydrobromide 15 mg/5mL; Promethazine hydrochloride 6.25 mg/5mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-1070 |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral | Dextromethorphan hydrobromide 15 mg/5mL; Promethazine hydrochloride 6.25 mg/5mL | SolutionOral | A-S Medication Solutions | 50090-6585 |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution | Dextromethorphan hydrobromide 15 mg/5mL; Promethazine hydrochloride 6.25 mg/5mL | SolutionOral | ATLANTIC BIOLOGICALS CORP. | 17856-0155 |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution | Dextromethorphan hydrobromide 15 mg/5mL; Promethazine hydrochloride 6.25 mg/5mL | SolutionOral | Proficient Rx LP | 71205-654 |