Cyclobenzaprine Hydrochloride NDC 63187-094

NDC codes

FDA NDC Directory

Product NDC (as listed)63187-094Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63187-0094Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
63187-094-10	63187009410	10 TABLET, FILM COATED in 1 BOTTLE (63187-094-10)Marketed from Jun 1, 2018
63187-094-15	63187009415	15 TABLET, FILM COATED in 1 BOTTLE (63187-094-15)Marketed from Jan 13, 2020
63187-094-30	63187009430	30 TABLET, FILM COATED in 1 BOTTLE (63187-094-30)Marketed from Jul 1, 2015
63187-094-40	63187009440	40 TABLET, FILM COATED in 1 BOTTLE (63187-094-40)Marketed from Mar 24, 2020
63187-094-60	63187009460	60 TABLET, FILM COATED in 1 BOTTLE (63187-094-60)Marketed from Jul 1, 2015
63187-094-72	63187009472	120 TABLET, FILM COATED in 1 BOTTLE (63187-094-72)Marketed from Jul 1, 2015
63187-094-78	63187009478	180 TABLET, FILM COATED in 1 BOTTLE (63187-094-78)Marketed from Jul 1, 2015
63187-094-90	63187009490	90 TABLET, FILM COATED in 1 BOTTLE (63187-094-90)Marketed from Jul 1, 2015

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: Proficient Rx LP
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078048
Marketing start: Jul 31, 2014
Listing expires: Dec 31, 2026
Other FDA classes: Centrally-mediated Muscle Relaxation (Physiologic effect)
Identifiers: Product ID 63187-094_6d258146-9e61-40a6-b433-d5fb21aecc5eSPL ID 6d258146-9e61-40a6-b433-d5fb21aecc5eSPL set ID f14bc532-e30f-490f-b97b-d0dab9a2ba0cRxCUI 828320UNII 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

N463187009410 followed by a unit qualifier and the quantity

Package 63187-0094-10. 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 Oct 1, 2021.

Indications (excerpt from the label)

INDICATIONS & USAGE Cyclobenzaprine hydrochloride tablets, USP 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 hydrochloride tablets, USP 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078048

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 078048
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 5 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	43063-494
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 10 mg/1	Tablet, Film coatedOral	KVK-TECH, Inc.	10702-007