Prescription drug · NDA AUTHORIZED GENERIC
Cyclobenzaprine HCL ER (Cyclobenzaprine hcl) NDC 80425-0292
Cyclobenzaprine hydrochloride 15 mg/1 · Capsule, Extended release · Oral · Advanced Rx Pharmacy of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0292-1 | 8042502920180425029201 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0292-1)Marketed from Mar 31, 2023 | |
| 80425-0292-2 | 8042502920280425029202 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0292-2)Marketed from Mar 31, 2023 | |
| 80425-0292-3 | 8042502920380425029203 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0292-3)Marketed from Mar 31, 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)
- Cyclobenzaprine HCL ERSuffix: ER
- Generic name (nonproprietary)
- cyclobenzaprine hcl
- Active ingredients
- Cyclobenzaprine hydrochloride — 15 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 021777
- Marketing start
- Listing expires
- Other FDA classes
- Centrally-mediated Muscle Relaxation (Physiologic effect)
- Identifiers
- Product ID 80425-0292_2a9bfe6a-6d67-b262-e063-6294a90a1cf3SPL ID 2a9bfe6a-6d67-b262-e063-6294a90a1cf3SPL set ID f8360da5-f1d3-1d89-e053-6294a90ad31cRxCUI 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
N480425029201followed by a unit qualifier and the quantityPackage 80425-0292-01. 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)
1. Indications and Usage 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 dura…
Excerpt only. Read the full label for complete information.
About NDC 80425-0292
- What is NDC 80425-0292?
- 80425-0292 is the product NDC for Cyclobenzaprine HCL ER (cyclobenzaprine hcl), Cyclobenzaprine hydrochloride 15 mg/1 capsule, extended release, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cyclobenzaprine HCL ER (Cyclobenzaprine HCL).
- What is the active ingredient?
- Cyclobenzaprine hydrochloride.
- Who is the labeler?
- Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cyclobenzaprine HCL ER?
- 2 other product NDCs are listed under this name. See all Cyclobenzaprine HCL ER NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cyclobenzaprine HCL ER products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cyclobenzaprine HCL ER | Cyclobenzaprine hydrochloride 15 mg/1 | Capsule, Extended releaseOral | Direct_Rx | 72189-389 | 72189-0389-60 |
| Cyclobenzaprine HCL ER | Cyclobenzaprine hydrochloride 15 mg/1 | Capsule, Extended releaseOral | Direct_Rx | 72189-362 | 72189-0362-60 |
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 |
|---|---|---|---|---|
| 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 HCL ER | Cyclobenzaprine hydrochloride 15 mg/1 | Capsule, Extended releaseOral | Direct_Rx | 72189-362 |
| 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 | Teva Pharmaceuticals USA, Inc. | 0093-1920 |
| 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 | 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 15 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 63629-8206 |
| 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 | Doc Rx | 69306-015 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 30 mg/1 | Capsule, Extended releaseOral | REMEDYREPACK INC. | 70518-4174 |
| 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 | Advanced Rx of Tennessee, LLC | 80425-0451 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 15 mg/1 | Capsule, Extended releaseOral | PHOENIX RX LLC | 85509-1920 |