Prescription drug · ANDA
Cyclobenzaprine Hydrochloride NDC 72789-046
Cyclobenzaprine hydrochloride 10 mg/1 · Tablet, Film coated · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72789-046-03 | 72789004603 | 3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-03)Marketed from Jan 7, 2020 | |
| 72789-046-04 | 72789004604 | 4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-04)Marketed from Jan 6, 2020 | |
| 72789-046-06 | 72789004606 | 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-06)Marketed from Jul 17, 2020 | |
| 72789-046-10 | 72789004610 | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-10)Marketed from Jan 8, 2020 | |
| 72789-046-12 | 72789004612 | 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-12)Marketed from Jun 15, 2020 | |
| 72789-046-14 | 72789004614 | 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-14)Marketed from Jan 27, 2020 | |
| 72789-046-20 | 72789004620 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-20)Marketed from Jan 6, 2020 | |
| 72789-046-30 | 72789004630 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-30)Marketed from Jan 6, 2020 | |
| 72789-046-40 | 72789004640 | 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-40)Marketed from Jun 1, 2020 | |
| 72789-046-60 | 72789004660 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-60)Marketed from Jan 6, 2020 |
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)
- Cyclobenzaprine Hydrochloride
- Generic name (nonproprietary)
- cyclobenzaprine hydrochloride
- Active ingredients
- Cyclobenzaprine hydrochloride — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077797
- Marketing start
- Listing expires
- Other FDA classes
- Centrally-mediated Muscle Relaxation (Physiologic effect)
- Identifiers
- Product ID 72789-046_3403a5e2-c822-d823-e063-6394a90a7142SPL ID 3403a5e2-c822-d823-e063-6394a90a7142SPL set ID 7829a96a-3668-4d88-90e9-0ecbedb2bd7eRxCUI 828348UNII 0VE05JYS2PUPC 0372789046303
- Pharmacologic class
- Muscle Relaxant
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
N472789004603followed by a unit qualifier and the quantityPackage 72789-0046-03. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 077797
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 |
|---|---|---|---|---|
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-1359 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-036 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 5 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-073 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-1210 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-1211 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0019 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 5 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-115 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 60429-876 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-033 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-156 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-201 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-9297 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-428 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Solco Healthcare U.S., LLC | 43547-399 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Solco Healthcare U.S., LLC | 43547-400 |