What is NDC 72189-545?

72189-545 is the product NDC for Cyclobenzaprine Hydrochloride, Cyclobenzaprine hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by Direct_Rx. It has 5 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 Hydrochloride?

223 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 72189-545

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-545Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0545Add 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
72189-545-15	72189054515	15 TABLET, FILM COATED in 1 BOTTLE (72189-545-15)Marketed from Apr 9, 2024
72189-545-21	72189054521	21 TABLET, FILM COATED in 1 BOTTLE (72189-545-21)Marketed from Apr 9, 2024
72189-545-30	72189054530	30 TABLET, FILM COATED in 1 BOTTLE (72189-545-30)Marketed from Apr 9, 2024
72189-545-60	72189054560	60 TABLET, FILM COATED in 1 BOTTLE (72189-545-60)Marketed from Apr 9, 2024
72189-545-90	72189054590	90 TABLET, FILM COATED in 1 BOTTLE (72189-545-90)Marketed from Apr 9, 2024

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: Direct_RxNDC labeler code 72189
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208170
Marketing start: Apr 9, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Centrally-mediated Muscle Relaxation (Physiologic effect)
Identifiers: Product ID 72189-545_4c4c0bb8-ab70-3f03-e063-6294a90af0b9SPL ID 4c4c0bb8-ab70-3f03-e063-6294a90af0b9SPL set ID 15aad4af-5c05-be36-e063-6294a90a9bb3RxCUI 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

N472189054515 followed by a unit qualifier and the quantity

Package 72189-0545-15. 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 Mar 5, 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 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 therapy for longer pe…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72189-545

What is NDC 72189-545?: 72189-545 is the product NDC for Cyclobenzaprine Hydrochloride, Cyclobenzaprine hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by Direct_Rx. It has 5 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?: 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 Hydrochloride?: 223 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	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	70518-4692-0070518-4692-01
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
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 30 mg/1	Capsule, Extended releaseOral	REMEDYREPACK INC.	70518-4523	70518-4523-00

All 224 Cyclobenzaprine Hydrochloride NDCs

Other NDCs under ANDA 208170

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

FDA NDC Directory listings under ANDA 208170
Product	Strength	Form · route	Labeler	Product NDC
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 10 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-1266
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 7.5 mg/1	Tablet, Film coatedOral	HAWAII REPACK, INC.	85534-0085
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 7.5 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals, Inc.	68071-3805
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 10 mg/1	Tablet, Film coatedOral	HAWAII REPACK, INC.	85534-0086
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 10 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-3561
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 5 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	51655-427
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 7.5 mg/1	Tablet, Film coatedOral	Asclemed USA, Inc.	76420-265
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 10 mg/1	Tablet, Film coatedOral	Sportpharm LLC	85766-003
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 5 mg/1	Tablet, Film coatedOral	Medcore LLC	82461-714
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 10 mg/1	Tablet, Film coatedOral	Medcore LLC	82461-716
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 10 mg/1	Tablet, Film coatedOral	Redpharm Drug	67296-2084
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 5 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8471
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 10 mg/1	Tablet, Film coatedOral	Unit Dose Solutions, Inc.	87441-010
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 10 mg/1	Tablet, Film coatedOral	Advanced Rx of Tennessee, LLC	80425-0498
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 10 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8474
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 10 mg/1	Tablet, Film coatedOral	DIRECT RX	72189-080
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 10 mg/1	Tablet, Film coatedOral	Sportpharm LLC	85766-041
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 10 mg/1	Tablet, Film coatedOral	PHOENIX RX LLC	85509-1014
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 5 mg/1	Tablet, Film coatedOral	QPharma, Inc.	42708-197
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 5 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3814

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