Prescription drug · ANDA
Fexmid (Cyclobenzaprine hydrochloride) NDC 64980-705
Cyclobenzaprine hydrochloride 7.5 mg/1 · Tablet · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64980-705-01 | 64980070501 | 100 TABLET in 1 BOTTLE (64980-705-01)Marketed from Mar 10, 2025 | |
| 64980-705-50 | 64980070550 | 500 TABLET in 1 BOTTLE (64980-705-50)Marketed from Mar 10, 2025 |
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)
- Fexmid
- Generic name (nonproprietary)
- cyclobenzaprine hydrochloride
- Active ingredients
- Cyclobenzaprine hydrochloride — 7.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Rising Pharma Holdings, Inc.NDC labeler code 64980
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218936
- Marketing start
- Listing expires
- Other FDA classes
- Centrally-mediated Muscle Relaxation (Physiologic effect)
- Identifiers
- Product ID 64980-705_8ebfc7eb-5a9a-4f3d-af2c-370732df074fSPL ID 8ebfc7eb-5a9a-4f3d-af2c-370732df074fSPL set ID 41838966-de0b-4855-83b8-2ff6c764ed1fRxCUI 828299, 828301UNII 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
N464980070501followed by a unit qualifier and the quantityPackage 64980-0705-01. 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 Fexmid ® is 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. Fexmid ® 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 for longer periods is seldom warranted. Fexmid ® …
Excerpt only. Read the full label for complete information.
About NDC 64980-705
- What is NDC 64980-705?
- 64980-705 is the product NDC for Fexmid (cyclobenzaprine hydrochloride), Cyclobenzaprine hydrochloride 7.5 mg/1 tablet, listed with the FDA by Rising Pharma Holdings, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fexmid (Cyclobenzaprine Hydrochloride).
- What is the active ingredient?
- Cyclobenzaprine hydrochloride.
- Who is the labeler?
- Rising Pharma Holdings, Inc., NDC labeler code 64980. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Fexmid?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 218936
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 10 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8665 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 5 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 64980-655 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 64980-657 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4692 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2666 |