What is NDC 42291-154?

42291-154 is the product NDC for Cyclobenzaprine Hydrochloride, Cyclobenzaprine hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by AvKARE. It has 8 package NDCs, shown above in 10- and 11-digit form.

AvKARE, NDC labeler code 42291. 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 42291-154

NDC codes

FDA NDC Directory

Product NDC (as listed)42291-154Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42291-0154Add 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
42291-154-10	4229101541042291015410	1000 TABLET, FILM COATED in 1 BOTTLE (42291-154-10)Marketed from Apr 3, 2020
42291-154-12	4229101541242291015412	120 TABLET, FILM COATED in 1 BOTTLE (42291-154-12)Marketed from Apr 3, 2020
42291-154-18	4229101541842291015418	180 TABLET, FILM COATED in 1 BOTTLE (42291-154-18)Marketed from Apr 3, 2020
42291-154-27	4229101542742291015427	270 TABLET, FILM COATED in 1 BOTTLE (42291-154-27)Marketed from Apr 3, 2020
42291-154-30	4229101543042291015430	30 TABLET, FILM COATED in 1 BOTTLE (42291-154-30)Marketed from Apr 3, 2020
42291-154-45	4229101544542291015445	45 TABLET, FILM COATED in 1 BOTTLE (42291-154-45)Marketed from Apr 3, 2020
42291-154-60	4229101546042291015460	60 TABLET, FILM COATED in 1 BOTTLE (42291-154-60)Marketed from Apr 3, 2020
42291-154-90	4229101549042291015490	90 TABLET, FILM COATED in 1 BOTTLE (42291-154-90)Marketed from Apr 3, 2020

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 — 10 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: AvKARENDC labeler code 42291
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077563
Marketing start: Apr 3, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Centrally-mediated Muscle Relaxation (Physiologic effect)
Identifiers: Product ID 42291-154_3ab20dcb-627a-53c4-e063-6394a90a20cbSPL ID 3ab20dcb-627a-53c4-e063-6394a90a20cbSPL set ID a264ab9f-cc12-325f-e053-2a95a90a53d9RxCUI 828348UNII 0VE05JYS2PUPC 0342291154605
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

N442291015410 followed by a unit qualifier and the quantity

Package 42291-0154-10. 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 Jul 24, 2025.

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 should be used only for short periods (up to 2 or 3 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42291-154

What is NDC 42291-154?: 42291-154 is the product NDC for Cyclobenzaprine Hydrochloride, Cyclobenzaprine hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by AvKARE. It has 8 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?: AvKARE, NDC labeler code 42291. 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 077563

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

FDA NDC Directory listings under ANDA 077563
Product	Strength	Form · route	Labeler	Product NDC
Cyclobenzaprine HCL	Cyclobenzaprine hydrochloride 10 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-680
Cyclobenzaprine HCL	Cyclobenzaprine hydrochloride 5 mg/1	Tablet, Film coatedOral	Advanced Rx of Tennessee, LLC	80425-0017
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 10 mg/1	Tablet, Film coatedOral	Jubilant Cadista Pharmaceuticals Inc.	59746-177
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 5 mg/1	Tablet, Film coatedOral	Jubilant Cadista Pharmaceuticals Inc.	59746-211
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 7.5 mg/1	Tablet, Film coatedOral	Jubilant Cadista Pharmaceuticals Inc.	59746-735
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 5 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	63629-2424
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 10 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1645
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 10 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-4154
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 10 mg/1	Tablet, Film coatedOral	Doc Rx	69306-872
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 7.5 mg/1	Tablet, Film coatedOral	SA3, LLC	69420-1001
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 10 mg/1	Tablet, Film coatedOral	SOLA Pharmaceuticals, LLC	70512-872
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 10 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-907
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 5 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-1692
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 10 mg/1	Tablet, Film coatedOral	Advanced Rx of Tennessee, LLC	80425-0547