Prescription drug · ANDA
Cyclobenzaprine Hydrochloride NDC 76420-269
Cyclobenzaprine hydrochloride 5 mg/1 · Tablet, Film coated · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-269-01 | 76420026901 | 1 TABLET, FILM COATED in 1 BOTTLE (76420-269-01)Marketed from Sep 3, 2022 | |
| 76420-269-02 | 76420026902 | 2 TABLET, FILM COATED in 1 BOTTLE (76420-269-02)Marketed from Sep 3, 2022 | |
| 76420-269-07 | 76420026907 | 7 TABLET, FILM COATED in 1 BOTTLE (76420-269-07)Marketed from Sep 3, 2022 | |
| 76420-269-10 | 76420026910 | 100 TABLET, FILM COATED in 1 BOTTLE (76420-269-10)Marketed from Sep 3, 2022 | |
| 76420-269-15 | 76420026915 | 15 TABLET, FILM COATED in 1 BOTTLE (76420-269-15)Marketed from Sep 3, 2022 | |
| 76420-269-20 | 76420026920 | 20 TABLET, FILM COATED in 1 BOTTLE (76420-269-20)Marketed from Sep 3, 2022 | |
| 76420-269-30 | 76420026930 | 30 TABLET, FILM COATED in 1 BOTTLE (76420-269-30)Marketed from Sep 3, 2022 | |
| 76420-269-60 | 76420026960 | 60 TABLET, FILM COATED in 1 BOTTLE (76420-269-60)Marketed from Sep 3, 2022 | |
| 76420-269-90 | 76420026990 | 90 TABLET, FILM COATED in 1 BOTTLE (76420-269-90)Marketed from Sep 3, 2022 |
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 — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Asclemed USA, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 071611
- Marketing start
- Listing expires
- Other FDA classes
- Centrally-mediated Muscle Relaxation (Physiologic effect)
- Identifiers
- Product ID 76420-269_e7bfa09d-7e18-d2bf-e053-2995a90a9145SPL ID e7bfa09d-7e18-d2bf-e053-2995a90a9145SPL set ID f8dec4e2-3151-4a79-b194-a11a57ada0b6RxCUI 828299, 828320, 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
N476420026901followed by a unit qualifier and the quantityPackage 76420-0269-01. 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 HCl 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. Cyclobenzaprine HCl 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 seldo…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 071611
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 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-271 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 7.5 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-268 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3627 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-3420 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 7.5 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-3421 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-3422 |