What is NDC 72189-680?

72189-680 is the product NDC for Cyclobenzaprine HCL, Cyclobenzaprine hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by Direct_Rx. It has 3 package NDCs, shown above in 10- and 11-digit form.

Direct_Rx, NDC labeler code 72189. 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 HCL?

6 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Cyclobenzaprine HCL NDC 72189-680 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-680Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0680Add 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
72189-680-30	7218906803072189068030	30 TABLET, FILM COATED in 1 BOTTLE (72189-680-30)Marketed from Jun 29, 2026
72189-680-60	7218906806072189068060	60 TABLET, FILM COATED in 1 BOTTLE (72189-680-60)Marketed from Jun 29, 2026
72189-680-90	7218906809072189068090	90 TABLET, FILM COATED in 1 BOTTLE (72189-680-90)Marketed from Jun 29, 2026

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 HCL
Generic name (nonproprietary): cyclobenzaprine hcl
Active ingredients: Cyclobenzaprine hydrochloride — 10 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Direct_RxNDC labeler code 72189
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077563
Marketing start: Jun 29, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Centrally-mediated Muscle Relaxation (Physiologic effect)
Identifiers: Product ID 72189-680_558c977f-c5be-188a-e063-6294a90adf7aSPL ID 558c977f-c5be-188a-e063-6294a90adf7aSPL set ID 55683c5c-0f86-9a26-e063-6294a90a8e8cRxCUI 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

N472189068030 followed by a unit qualifier and the quantity

Package 72189-0680-30. 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 1, 2026.

Indications (excerpt from the label)

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 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 lon…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72189-680

What is NDC 72189-680?: 72189-680 is the product NDC for Cyclobenzaprine HCL, Cyclobenzaprine hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by Direct_Rx. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Cyclobenzaprine HCL.
What is the active ingredient?: Cyclobenzaprine hydrochloride.
Who is the labeler?: Direct_Rx, NDC labeler code 72189. 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 HCL?: 6 other product NDCs are listed under this name. See all Cyclobenzaprine HCL 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 HCL NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Cyclobenzaprine HCL	Cyclobenzaprine hydrochloride 5 mg/1	Tablet, Film coatedOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0155	80425-0155-0180425-0155-0280425-0155-03+2 more
Cyclobenzaprine HCL	Cyclobenzaprine hydrochloride 5 mg/1	Tablet, Film coatedOral	Advanced Rx of Tennessee, LLC	80425-0016	80425-0016-0180425-0016-0280425-0016-03+1 more
Cyclobenzaprine HCL	Cyclobenzaprine hydrochloride 10 mg/1	Tablet, Film coatedOral	Advanced Rx of Tennessee, LLC	80425-0018	80425-0018-0180425-0018-0280425-0018-03
Cyclobenzaprine HCL	Cyclobenzaprine hydrochloride 7.5 mg/1	Tablet, Film coatedOral	Advanced Rx of Tennessee, LLC	80425-0078	80425-0078-0180425-0078-0280425-0078-03+1 more
Cyclobenzaprine HCL	Cyclobenzaprine hydrochloride 7.5 mg/1	Tablet, Film coatedOral	PHOENIX RX LLC	85509-1001	85509-1001-0185509-1001-0385509-1001-06+1 more
Cyclobenzaprine HCL	Cyclobenzaprine hydrochloride 5 mg/1	Tablet, Film coatedOral	Advanced Rx of Tennessee, LLC	80425-0017	80425-0017-01

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 5 mg/1	Tablet, Film coatedOral	Advanced Rx of Tennessee, LLC	80425-0017
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 10 mg/1	Tablet, Film coatedOral	AvKARE	42291-154
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