Prescription drug · ANDA
Cyclobenzaprine Hydrochloride NDC 50090-1848
Cyclobenzaprine hydrochloride 7.5 mg/1 · Tablet, Film coated · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-1848-0 | 50090184800 | 15 TABLET, FILM COATED in 1 BOTTLE (50090-1848-0)Marketed from May 28, 2015 | |
| 50090-1848-1 | 50090184801 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-1848-1)Marketed from May 28, 2015 | |
| 50090-1848-2 | 50090184802 | 60 TABLET, FILM COATED in 1 BOTTLE (50090-1848-2)Marketed from May 28, 2015 |
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)
- Cyclobenzaprine Hydrochloride
- Generic name (nonproprietary)
- cyclobenzaprine hydrochloride
- Active ingredients
- Cyclobenzaprine hydrochloride — 7.5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078722
- Marketing start
- Listing expires
- Other FDA classes
- Centrally-mediated Muscle Relaxation (Physiologic effect)
- Identifiers
- Product ID 50090-1848_1152b0be-6787-461b-bf78-695595c2c63bSPL ID 1152b0be-6787-461b-bf78-695595c2c63bSPL set ID 81917fa4-c79c-46e2-bfbb-507fc0d7ed1bRxCUI 828299UNII 0VE05JYS2P
- 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
N450090184800followed by a unit qualifier and the quantityPackage 50090-1848-00. 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 Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078722
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 7.5 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-590 |
| Cyclobenzaprine HCL | Cyclobenzaprine hydrochloride 7.5 mg/1 | Tablet, Film coatedOral | PHOENIX RX LLC | 85509-1001 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 7.5 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-010 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 7.5 mg/1 | Tablet, Film coatedOral | Direct_Rx | 61919-261 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 7.5 mg/1 | Tablet, Film coatedOral | SA3, LLC | 69420-1001 |
| Cyclobenzaprine HCL | Cyclobenzaprine hydrochloride 7.5 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0078 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 7.5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0096 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 7.5 mg/1 | Tablet, Film coatedOral | Quality Care Products LLC | 55700-239 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 7.5 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals, Inc. | 68788-9967 |