What is NDC 76420-268?

76420-268 is the product NDC for Cyclobenzaprine Hydrochloride, Cyclobenzaprine hydrochloride 7.5 mg/1 tablet, film coated, listed with the FDA by Asclemed USA, Inc.. It has 9 package NDCs, shown above in 10- and 11-digit form.

Asclemed USA, Inc., NDC labeler code 76420. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Cyclobenzaprine Hydrochloride?

221 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Cyclobenzaprine Hydrochloride NDC 76420-268

NDC codes

FDA NDC Directory

Product NDC (as listed)76420-268Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76420-0268Add 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
76420-268-01	7642002680176420026801	1 TABLET, FILM COATED in 1 BOTTLE (76420-268-01)Marketed from Sep 3, 2022
76420-268-02	7642002680276420026802	2 TABLET, FILM COATED in 1 BOTTLE (76420-268-02)Marketed from Sep 3, 2022
76420-268-07	7642002680776420026807	7 TABLET, FILM COATED in 1 BOTTLE (76420-268-07)Marketed from Sep 3, 2022
76420-268-10	7642002681076420026810	100 TABLET, FILM COATED in 1 BOTTLE (76420-268-10)Marketed from Sep 3, 2022
76420-268-15	7642002681576420026815	15 TABLET, FILM COATED in 1 BOTTLE (76420-268-15)Marketed from Sep 3, 2022
76420-268-20	7642002682076420026820	20 TABLET, FILM COATED in 1 BOTTLE (76420-268-20)Marketed from Sep 3, 2022
76420-268-30	7642002683076420026830	30 TABLET, FILM COATED in 1 BOTTLE (76420-268-30)Marketed from Sep 3, 2022
76420-268-60	7642002686076420026860	60 TABLET, FILM COATED in 1 BOTTLE (76420-268-60)Marketed from Sep 3, 2022
76420-268-90	7642002689076420026890	90 TABLET, FILM COATED in 1 BOTTLE (76420-268-90)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 — 7.5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Asclemed USA, Inc.NDC labeler code 76420
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 071611
Marketing start: Jul 20, 2021
Listing expires: Dec 31, 2027
Other FDA classes: Centrally-mediated Muscle Relaxation (Physiologic effect)
Identifiers: Product ID 76420-268_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

N476420026801 followed by a unit qualifier and the quantity

Package 76420-0268-01. 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 Sep 3, 2022.

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.

Full label on DailyMed (opens in a new tab)

About NDC 76420-268

What is NDC 76420-268?: 76420-268 is the product NDC for Cyclobenzaprine Hydrochloride, Cyclobenzaprine hydrochloride 7.5 mg/1 tablet, film coated, listed with the FDA by Asclemed USA, Inc.. It has 9 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Cyclobenzaprine Hydrochloride.
What is the active ingredient?: Cyclobenzaprine hydrochloride.
Who is the labeler?: Asclemed USA, Inc., NDC labeler code 76420. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cyclobenzaprine Hydrochloride?: 221 other product NDCs are listed under this name. See all Cyclobenzaprine Hydrochloride NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Cyclobenzaprine Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 7.5 mg/1	Tablet, Film coatedOral	Carol Way Pharma LLC	85437-013	85437-0013-10
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 7.5 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4751	70518-4751-00
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 10 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-4154	68788-4154-0268788-4154-0368788-4154-05+2 more
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 10 mg/1	TabletOral	REMEDYREPACK INC.	70518-4692	70518-4692-0070518-4692-0170518-4692-02
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 10 mg/1	Tablet, Film coatedOral	Unit Dose Solutions, Inc.	87441-010	87441-0010-01
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 5 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1110	67046-1110-03
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 15 mg/1	Capsule, Extended releaseOral	Preferred Pharmaceuticals Inc.	68788-4087	68788-4087-0368788-4087-06
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 5 mg/1	Tablet, Film coatedOral	Medcore LLC	82461-714	82461-0714-90
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 10 mg/1	Tablet, Film coatedOral	Medcore LLC	82461-716	82461-0716-90
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 10 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1645	67046-1645-03

All 222 Cyclobenzaprine Hydrochloride NDCs

Other NDCs under ANDA 071611

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

FDA NDC Directory listings under ANDA 071611
Product	Strength	Form · route	Labeler	Product NDC
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
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	Asclemed USA, Inc.	76420-269
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 10 mg/1	Tablet, Film coatedOral	Asclemed USA, Inc.	76420-271