Cyclobenzaprine Hydrochloride NDC 76420-010

NDC codes

FDA NDC Directory

Product NDC (as listed)76420-010Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76420-0010Add 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
76420-010-01	76420001001	100 TABLET, FILM COATED in 1 BOTTLE (76420-010-01)Marketed from Oct 21, 2022
76420-010-05	76420001005	500 TABLET, FILM COATED in 1 BOTTLE (76420-010-05)Marketed from Oct 21, 2022
76420-010-12	76420001012	120 TABLET, FILM COATED in 1 BOTTLE (76420-010-12)Marketed from Mar 16, 2023
76420-010-15	76420001015	15 TABLET, FILM COATED in 1 BOTTLE (76420-010-15)Marketed from Oct 21, 2022
76420-010-30	76420001030	30 TABLET, FILM COATED in 1 BOTTLE (76420-010-30)Marketed from Jan 23, 2020
76420-010-60	76420001060	60 TABLET, FILM COATED in 1 BOTTLE (76420-010-60)Marketed from Jan 23, 2020
76420-010-90	76420001090	90 TABLET, FILM COATED in 1 BOTTLE (76420-010-90)Marketed from Oct 21, 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 — 7.5 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 078722
Marketing start: Sep 28, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Centrally-mediated Muscle Relaxation (Physiologic effect)
Identifiers: Product ID 76420-010_17d7186f-a791-93d2-e063-6294a90ac7d4SPL ID 17d7186f-a791-93d2-e063-6294a90ac7d4SPL set ID 07e3ec53-f1f2-4231-aec6-1772a146ba88RxCUI 828299UNII 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

N476420001001 followed by a unit qualifier and the quantity

Package 76420-0010-01. 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 May 7, 2024.

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, 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 a…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078722

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

FDA NDC Directory listings under ANDA 078722
Product	Strength	Form · route	Labeler	Product NDC
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 7.5 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-590
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 7.5 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-1848
Cyclobenzaprine HCL	Cyclobenzaprine hydrochloride 7.5 mg/1	Tablet, Film coatedOral	PHOENIX RX LLC	85509-1001
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 7.5 mg/1	Tablet, Film coatedOral	Direct_Rx	61919-261
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 7.5 mg/1	Tablet, Film coatedOral	SA3, LLC	69420-1001
Cyclobenzaprine HCL	Cyclobenzaprine hydrochloride 7.5 mg/1	Tablet, Film coatedOral	Advanced Rx of Tennessee, LLC	80425-0078
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 7.5 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0096
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 7.5 mg/1	Tablet, Film coatedOral	Quality Care Products LLC	55700-239
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 7.5 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals, Inc.	68788-9967