Prescription drug · ANDA

Cyclobenzaprine Hydrochloride NDC 60760-766

Cyclobenzaprine hydrochloride 5 mg/1 · Tablet, Film coated · Oral · ST. MARY'S MEDICAL PARK PHARMACY

NDC codes

FDA NDC Directory
Product NDC (as listed)60760-766Labeler and product segments. Claims need a package NDC.
Product NDC at billing width60760-0766Add 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
60760-766-04607600766044 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-766-04)Marketed from Jun 29, 2023
60760-766-156076007661515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-766-15)Marketed from Jun 29, 2023
60760-766-306076007663030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-766-30)Marketed from May 31, 2017
60760-766-906076007669090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-766-90)Marketed from Nov 1, 2023

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 — 5 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 60760-766_52465554-8bbf-6ffa-e063-6394a90a87cfSPL ID 52465554-8bbf-6ffa-e063-6394a90a87cfSPL set ID 00b20a8c-debd-e930-e063-6394a90a7ed0RxCUI 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

N460760076604 followed by a unit qualifier and the quantity

Package 60760-0766-04. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

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 coatedOralProficient Rx LP71205-065
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

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