What is NDC 85509-1001?

85509-1001 is the product NDC for Cyclobenzaprine HCL, Cyclobenzaprine hydrochloride 7.5 mg/1 tablet, film coated, listed with the FDA by PHOENIX RX LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.

PHOENIX RX LLC, NDC labeler code 85509. 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 85509-1001

NDC codes

FDA NDC Directory

Product NDC (as listed)85509-1001Labeler and product segments. Claims need a package NDC.

Product NDC at billing width85509-1001Add 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
85509-1001-1	8550910010185509100101	120 TABLET, FILM COATED in 1 BOTTLE (85509-1001-1)Marketed from Jul 21, 2025
85509-1001-3	8550910010385509100103	30 TABLET, FILM COATED in 1 BOTTLE (85509-1001-3)Marketed from Jul 21, 2025
85509-1001-6	8550910010685509100106	60 TABLET, FILM COATED in 1 BOTTLE (85509-1001-6)Marketed from Jul 21, 2025
85509-1001-9	8550910010985509100109	90 TABLET, FILM COATED in 1 BOTTLE (85509-1001-9)Marketed from Jul 21, 2025

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 7.5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: PHOENIX RX LLCNDC labeler code 85509
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078722
Marketing start: Mar 25, 2015
Listing expires: Dec 31, 2027
Other FDA classes: Centrally-mediated Muscle Relaxation (Physiologic effect)
Identifiers: Product ID 85509-1001_488202dc-28f3-ad46-e063-6294a90a4238SPL ID 488202dc-28f3-ad46-e063-6294a90a4238SPL set ID 3a397e88-d267-feed-e063-6294a90a7710RxCUI 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

N485509100101 followed by a unit qualifier and the quantity

Package 85509-1001-01. 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 Jan 16, 2026.

Indications (excerpt from the label)

Indications and Usage Section 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 85509-1001

What is NDC 85509-1001?: 85509-1001 is the product NDC for Cyclobenzaprine HCL, Cyclobenzaprine hydrochloride 7.5 mg/1 tablet, film coated, listed with the FDA by PHOENIX RX LLC. It has 4 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?: PHOENIX RX LLC, NDC labeler code 85509. 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 10 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-680	72189-0680-3072189-0680-6072189-0680-90
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 5 mg/1	Tablet, Film coatedOral	Advanced Rx of Tennessee, LLC	80425-0017	80425-0017-01

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	Asclemed USA, Inc.	76420-010
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 7.5 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals, Inc.	68788-9967
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 7.5 mg/1	Tablet, Film coatedOral	Quality Care Products LLC	55700-239
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	Proficient Rx LP	63187-590
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 7.5 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-1848
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 7.5 mg/1	Tablet, Film coatedOral	Direct_Rx	61919-261