Prescription drug · ANDA
Cyclobenzaprine Hydrochloride NDC 71205-454
Cyclobenzaprine hydrochloride 15 mg/1 · Capsule, Extended release · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-454-30 | 7120504543071205045430 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-454-30)Marketed from May 26, 2020 | |
| 71205-454-42 | 7120504544271205045442 | 42 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-454-42)Marketed from May 26, 2020 | |
| 71205-454-60 | 7120504546071205045460 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-454-60)Marketed from May 26, 2020 | |
| 71205-454-90 | 7120504549071205045490 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-454-90)Marketed from May 26, 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 — 15 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 71205
- 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 71205-454_a5a3c82e-1d99-4a5e-82c9-2d1f63f4dd6fSPL ID a5a3c82e-1d99-4a5e-82c9-2d1f63f4dd6fSPL set ID d8112916-28ae-452c-8ec8-a4972e5f549bRxCUI 828358UNII 0VE05JYS2PUPC 0371205454302
- 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
N471205045430followed by a unit qualifier and the quantityPackage 71205-0454-30. 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.
About NDC 71205-454
- What is NDC 71205-454?
- 71205-454 is the product NDC for Cyclobenzaprine Hydrochloride, Cyclobenzaprine hydrochloride 15 mg/1 capsule, extended release, listed with the FDA by Proficient Rx LP. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cyclobenzaprine Hydrochloride.
- What is the active ingredient?
- Cyclobenzaprine hydrochloride.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 71205. 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 Hydrochloride?
- 221 other product NDCs are listed under this name. See all Cyclobenzaprine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cyclobenzaprine Hydrochloride 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 Hydrochloride | Cyclobenzaprine hydrochloride 7.5 mg/1 | Tablet, Film coatedOral | Carol Way Pharma LLC | 85437-013 | 85437-0013-10 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 7.5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4751 | 70518-4751-00 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4154 | 68788-4154-0268788-4154-0368788-4154-05+2 more |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4692 | 70518-4692-0070518-4692-0170518-4692-02 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-010 | 87441-0010-01 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1110 | 67046-1110-03 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 15 mg/1 | Capsule, Extended releaseOral | Preferred Pharmaceuticals Inc. | 68788-4087 | 68788-4087-0368788-4087-06 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Medcore LLC | 82461-714 | 82461-0714-90 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Medcore LLC | 82461-716 | 82461-0716-90 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1645 | 67046-1645-03 |
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 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 | Preferred Pharmaceuticals, Inc. | 68788-8522 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 15 mg/1 | Capsule, Extended releaseOral | REMEDYREPACK INC. | 70518-4225 |
| 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 | 71205-857 |
| 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 | Bryant Ranch Prepack | 71335-2514 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 15 mg/1 | Capsule, Extended releaseOral | DIRECT RX | 72189-101 |
| 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 | Advanced Rx of Tennessee, LLC | 80425-0460 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 15 mg/1 | Capsule, Extended releaseOral | PHOENIX RX LLC | 85509-1035 |