Prescription drug · ANDA
Cyclobenzaprine Hydrochloride NDC 68788-8522
Cyclobenzaprine hydrochloride 15 mg/1 · Capsule, Extended release · Oral · Preferred Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8522-3 | 68788852203 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-8522-3)Marketed from Sep 12, 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 Hydrochloride
- Generic name (nonproprietary)
- cyclobenzaprine hydrochloride
- Active ingredients
- Cyclobenzaprine hydrochloride — 15 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091281
- Marketing start
- Listing expires
- Other FDA classes
- Centrally-mediated Muscle Relaxation (Physiologic effect)
- Identifiers
- Product ID 68788-8522_43afe4e0-c50f-427c-a7bd-a6a1ba3f41beSPL ID 43afe4e0-c50f-427c-a7bd-a6a1ba3f41beSPL set ID 550d3e5a-c95f-4094-a500-1a02ea35a18dRxCUI 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
N468788852203followed by a unit qualifier and the quantityPackage 68788-8522-03. 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
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 thera…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091281
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 30 mg/1 | Capsule, Extended releaseOral | Proficient Rx LP | 71205-858 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 15 mg/1 | Capsule, Extended releaseOral | REMEDYREPACK INC. | 70518-4225 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 15 mg/1 | Capsule, Extended releaseOral | Upsher-Smith Laboratories, LLC | 24979-035 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 30 mg/1 | Capsule, Extended releaseOral | Upsher-Smith Laboratories, LLC | 24979-036 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 15 mg/1 | Capsule, Extended releaseOral | DIRECT RX | 72189-101 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 15 mg/1 | Capsule, Extended releaseOral | Advanced Rx of Tennessee, LLC | 80425-0460 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 15 mg/1 | Capsule, Extended releaseOral | PHOENIX RX LLC | 85509-1035 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 30 mg/1 | Capsule, Extended releaseOral | REMEDYREPACK INC. | 70518-4523 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 15 mg/1 | Capsule, Extended releaseOral | Proficient Rx LP | 71205-454 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 15 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-2514 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 15 mg/1 | Capsule, Extended releaseOral | Asclemed USA, Inc. | 76420-895 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 30 mg/1 | Capsule, Extended releaseOral | Asclemed USA, Inc. | 76420-896 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 15 mg/1 | Capsule, Extended releaseOral | Proficient Rx LP | 71205-857 |