Prescription drug · NDA
Cyclobenzaprine HCL ER NDC 72189-362
Cyclobenzaprine hydrochloride 15 mg/1 · Capsule, Extended release · Oral · Direct_Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-362-60 | 72189036260 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72189-362-60)Marketed from Jul 25, 2022 |
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 HCL ER
- Generic name (nonproprietary)
- cyclobenzaprine hcl er
- Active ingredients
- Cyclobenzaprine hydrochloride — 15 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Direct_Rx
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021777
- Marketing start
- Listing expires
- Other FDA classes
- Centrally-mediated Muscle Relaxation (Physiologic effect)
- Identifiers
- Product ID 72189-362_2c4c9187-3348-d75f-e063-6394a90a9231SPL ID 2c4c9187-3348-d75f-e063-6394a90a9231SPL set ID e4a3383a-7b30-25b7-e053-2995a90a341bRxCUI 828358UNII 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
N472189036260followed by a unit qualifier and the quantityPackage 72189-0362-60. 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)
Cyclobenzaprine hydrochloride extended-release capsules 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, and limitation of motion. Limitations of Use: Cyclobenzaprine hydrochloride extended-release capsules should be used only for short periods (up to two or three 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 therapy…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021777
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 HCL ER | Cyclobenzaprine hydrochloride 15 mg/1 | Capsule, Extended releaseOral | Direct_Rx | 72189-389 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 15 mg/1 | Capsule, Extended releaseOral | Advanced Rx of Tennessee, LLC | 80425-0451 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 15 mg/1 | Capsule, Extended releaseOral | REMEDYREPACK INC. | 70518-4246 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 30 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-2696 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 15 mg/1 | Capsule, Extended releaseOral | Teva Pharmaceuticals USA, Inc. | 0093-1920 |
| Amrixcyclobenzaprine hydrochloride | Cyclobenzaprine hydrochloride 15 mg/1 | Capsule, Extended releaseOral | Cephalon, LLC | 63459-700 |
| Amrixcyclobenzaprine hydrochloride | Cyclobenzaprine hydrochloride 30 mg/1 | Capsule, Extended releaseOral | Cephalon, LLC | 63459-701 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 15 mg/1 | Capsule, Extended releaseOral | PHOENIX RX LLC | 85509-1920 |
| Cyclobenzaprine HCL ERcyclobenzaprine hcl | Cyclobenzaprine hydrochloride 15 mg/1 | Capsule, Extended releaseOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0292 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 30 mg/1 | Capsule, Extended releaseOral | Teva Pharmaceuticals USA, Inc. | 0093-1921 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 15 mg/1 | Capsule, Extended releaseOral | Preferred Pharmaceuticals Inc. | 68788-4087 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 15 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals of New York LLC | 0115-1436 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 30 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals of New York LLC | 0115-1437 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 30 mg/1 | Capsule, Extended releaseOral | REMEDYREPACK INC. | 70518-4174 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 15 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 63629-8206 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 15 mg/1 | Capsule, Extended releaseOral | Doc Rx | 69306-015 |