Prescription drug · ANDA
Cyclobenzaprine Hydrochloride NDC 80425-0547
Cyclobenzaprine hydrochloride 10 mg/1 · Tablet, Film coated · Oral · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0547-1 | 8042505470180425054701 | 30 TABLET, FILM COATED in 1 BOTTLE (80425-0547-1)Marketed from Aug 8, 2025 | |
| 80425-0547-2 | 8042505470280425054702 | 60 TABLET, FILM COATED in 1 BOTTLE (80425-0547-2)Marketed from Aug 8, 2025 | |
| 80425-0547-3 | 8042505470380425054703 | 90 TABLET, FILM COATED in 1 BOTTLE (80425-0547-3)Marketed from Aug 8, 2025 |
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 — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Advanced Rx of Tennessee, LLCNDC labeler code 80425
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077563
- Marketing start
- Listing expires
- Other FDA classes
- Centrally-mediated Muscle Relaxation (Physiologic effect)
- Identifiers
- Product ID 80425-0547_3bddfe25-00bb-747f-e063-6394a90a9ce6SPL ID 3bddfe25-00bb-747f-e063-6394a90a9ce6SPL set ID 3bddfe25-00ba-747f-e063-6394a90a9ce6RxCUI 828348UNII 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
N480425054701followed by a unit qualifier and the quantityPackage 80425-0547-01. 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)
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 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 sp…
Excerpt only. Read the full label for complete information.
About NDC 80425-0547
- What is NDC 80425-0547?
- 80425-0547 is the product NDC for Cyclobenzaprine Hydrochloride, Cyclobenzaprine hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 3 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?
- Advanced Rx 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 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 077563
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 | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-680 |
| Cyclobenzaprine HCL | Cyclobenzaprine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0017 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-154 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Jubilant Cadista Pharmaceuticals Inc. | 59746-177 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Jubilant Cadista Pharmaceuticals Inc. | 59746-211 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 7.5 mg/1 | Tablet, Film coatedOral | Jubilant Cadista Pharmaceuticals Inc. | 59746-735 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-2424 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1645 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4154 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Doc Rx | 69306-872 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 7.5 mg/1 | Tablet, Film coatedOral | SA3, LLC | 69420-1001 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | SOLA Pharmaceuticals, LLC | 70512-872 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-907 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-1692 |