Prescription drug · ANDA
Cyclobenzaprine Hydrochloride NDC 43063-494
Cyclobenzaprine hydrochloride 5 mg/1 · Tablet, Film coated · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-494-01 | 43063049401 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-01)Marketed from Dec 5, 2018 | |
| 43063-494-10 | 43063049410 | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-10)Marketed from Jul 31, 2014 | |
| 43063-494-14 | 43063049414 | 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-14)Marketed from Jul 31, 2014 | |
| 43063-494-15 | 43063049415 | 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-15)Marketed from Jul 31, 2014 | |
| 43063-494-20 | 43063049420 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-20)Marketed from Sep 4, 2019 | |
| 43063-494-21 | 43063049421 | 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-21)Marketed from Jul 31, 2014 | |
| 43063-494-30 | 43063049430 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-30)Marketed from Jul 31, 2014 | |
| 43063-494-60 | 43063049460 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-60)Marketed from Jul 31, 2014 | |
| 43063-494-82 | 43063049482 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-82)Marketed from Dec 5, 2018 | |
| 43063-494-90 | 43063049490 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-90)Marketed from Jul 31, 2014 | |
| 43063-494-95 | 43063049495 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-95)Marketed from Dec 4, 2018 |
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
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078048
- Marketing start
- Listing expires
- Other FDA classes
- Centrally-mediated Muscle Relaxation (Physiologic effect)
- Identifiers
- Product ID 43063-494_4138b440-6586-92bc-e063-6394a90a3a3dSPL ID 4138b440-6586-92bc-e063-6394a90a3a3dSPL set ID e505c31b-4618-4e4f-8da6-92030464004fRxCUI 828320UNII 0VE05JYS2PUPC 0343063494219
- 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
N443063049401followed by a unit qualifier and the quantityPackage 43063-0494-01. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 078048
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 | Aphena Pharma Solutions - Tennessee, LLC | 71610-016 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 5 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-753 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 5 mg/1 | Tablet, Film coatedOral | KVK-TECH, Inc. | 10702-006 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 10 mg/1 | Tablet, Film coatedOral | KVK-TECH, Inc. | 10702-007 |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-094 |