Prescription drug · ANDA

Cyclobenzaprine Hydrochloride NDC 71205-065

Cyclobenzaprine hydrochloride 10 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP

NDC codes

FDA NDC Directory
Product NDC (as listed)71205-065Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71205-0065Add 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
71205-065-107120500651010 TABLET, FILM COATED in 1 BOTTLE (71205-065-10)Marketed from Jul 2, 2018
71205-065-127120500651212 TABLET, FILM COATED in 1 BOTTLE (71205-065-12)Marketed from Jul 2, 2018
71205-065-157120500651515 TABLET, FILM COATED in 1 BOTTLE (71205-065-15)Marketed from Jul 2, 2018
71205-065-207120500652020 TABLET, FILM COATED in 1 BOTTLE (71205-065-20)Marketed from Jul 2, 2018
71205-065-217120500652121 TABLET, FILM COATED in 1 BOTTLE (71205-065-21)Marketed from Jul 2, 2018
71205-065-307120500653030 TABLET, FILM COATED in 1 BOTTLE (71205-065-30)Marketed from Jul 2, 2018
71205-065-457120500654545 TABLET, FILM COATED in 1 BOTTLE (71205-065-45)Marketed from Jul 2, 2018
71205-065-607120500656060 TABLET, FILM COATED in 1 BOTTLE (71205-065-60)Marketed from Jul 2, 2018
71205-065-7271205006572120 TABLET, FILM COATED in 1 BOTTLE (71205-065-72)Marketed from Jul 2, 2018
71205-065-907120500659090 TABLET, FILM COATED in 1 BOTTLE (71205-065-90)Marketed from Jul 2, 2018

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
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 71205-065_7cb81f85-9453-48a6-a1dd-ac81e2de0dbaSPL ID 7cb81f85-9453-48a6-a1dd-ac81e2de0dbaSPL set ID 88bdee56-d6d9-4f14-be77-1e6898ba36f5RxCUI 828348UNII 0VE05JYS2PUPC 0371205065607
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

N471205006510 followed by a unit qualifier and the quantity

Package 71205-0065-10. 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 .

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)

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 HydrochlorideCyclobenzaprine hydrochloride 5 mg/1Tablet, Film coatedOralNORTHSTAR RX LLC72603-310
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 5 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3814
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 7.5 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-265
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralRedpharm Drug67296-2084
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8474
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 7.5 mg/1Tablet, Film coatedOralHAWAII REPACK, INC.85534-0085
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralDIRECT RX72189-080
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralHAWAII REPACK, INC.85534-0086
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralSportpharm LLC85766-003
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralUnit Dose Solutions, Inc.87441-010
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 5 mg/1Tablet, Film coatedOralQPharma, Inc.42708-197
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 5 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-547
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 5 mg/1Tablet, Film coatedOralMedcore LLC82461-714
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralMedcore LLC82461-716
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralSportpharm LLC85766-041
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralPHOENIX RX LLC85509-1014
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 7.5 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4751
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 5 mg/1Tablet, Film coatedOralNuCare Pharmaceutuicals,Inc.68071-4655
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralAdvanced Rx of Tennessee, LLC80425-0498
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 5 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc.68071-3915

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