Prescription drug · ANDA

Cyclobenzaprine HCL NDC 80425-0016

Cyclobenzaprine hydrochloride 5 mg/1 · Tablet, Film coated · Oral · Advanced Rx of Tennessee, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)80425-0016Labeler and product segments. Claims need a package NDC.
Product NDC at billing width80425-0016Add 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 NDC11-digit (billing)PackageCopy
80425-0016-18042500160160 TABLET, FILM COATED in 1 BOTTLE (80425-0016-1)Marketed from May 31, 2017
80425-0016-28042500160230 TABLET, FILM COATED in 1 BOTTLE (80425-0016-2)Marketed from May 31, 2017
80425-0016-38042500160390 TABLET, FILM COATED in 1 BOTTLE (80425-0016-3)Marketed from May 31, 2017
80425-0016-480425001604120 TABLET, FILM COATED in 1 BOTTLE (80425-0016-4)Marketed from May 31, 2017

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 — 5 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Advanced Rx of Tennessee, LLCNDC labeler code 80425
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 208170
Marketing start
Listing expires
Other FDA classes
Centrally-mediated Muscle Relaxation (Physiologic effect)
Identifiers
Product ID 80425-0016_2a985779-947a-6d0e-e063-6294a90aa2a7SPL ID 2a985779-947a-6d0e-e063-6294a90aa2a7SPL set ID afca1267-4d8f-7453-e053-2995a90a865cRxCUI 828320UNII 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

N480425001601 followed by a unit qualifier and the quantity

Package 80425-0016-01. 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 .

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 80425-0016

What is NDC 80425-0016?
80425-0016 is the product NDC for Cyclobenzaprine HCL, Cyclobenzaprine hydrochloride 5 mg/1 tablet, film coated, listed with the FDA by Advanced Rx of Tennessee, 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?
Advanced Rx of Tennessee, LLC, NDC labeler code 80425. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Cyclobenzaprine HCLCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralDirect_Rx72189-68072189-0680-3072189-0680-6072189-0680-90
Cyclobenzaprine HCLCyclobenzaprine hydrochloride 5 mg/1Tablet, Film coatedOralAdvanced Rx Pharmacy of Tennessee, LLC80425-015580425-0155-0180425-0155-0280425-0155-03+2 more
Cyclobenzaprine HCLCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralAdvanced Rx of Tennessee, LLC80425-001880425-0018-0180425-0018-0280425-0018-03
Cyclobenzaprine HCLCyclobenzaprine hydrochloride 7.5 mg/1Tablet, Film coatedOralAdvanced Rx of Tennessee, LLC80425-007880425-0078-0180425-0078-0280425-0078-03+1 more
Cyclobenzaprine HCLCyclobenzaprine hydrochloride 7.5 mg/1Tablet, Film coatedOralPHOENIX RX LLC85509-100185509-1001-0185509-1001-0385509-1001-06+1 more
Cyclobenzaprine HCLCyclobenzaprine hydrochloride 5 mg/1Tablet, Film coatedOralAdvanced Rx of Tennessee, LLC80425-001780425-0017-01

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
ProductStrengthForm · routeLabelerProduct NDC
Cyclobenzaprine HCLCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralAdvanced Rx of Tennessee, LLC80425-0018
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 5 mg/1Tablet, Film coatedOralQPharma, Inc.42708-197
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-4722
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-4727
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-4729
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-4730
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6864
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 5 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-427
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-539
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-592
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 5 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-818
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 5 mg/1Tablet, Film coatedOralTruPharma LLC52817-330
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 7.5 mg/1Tablet, Film coatedOralTruPharma LLC52817-331
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralTruPharma LLC52817-332
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 5 mg/1Tablet, Film coatedOralST. MARY'S MEDICAL PARK PHARMACY60760-766
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralST. MARY'S MEDICAL PARK PHARMACY60760-767
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 5 mg/1Tablet, Film coatedOralCoupler LLC67046-1110
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralCoupler LLC67046-1566
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralRedpharm Drug67296-2084
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralRedpharm Drug67296-2306

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