NDC codes

FDA NDC Directory
Product NDC (as listed)76420-599Labeler and product segments. Claims need a package NDC.
Product NDC at billing width76420-0599Add 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
76420-599-02764200599022 TABLET, FILM COATED in 1 BOTTLE (76420-599-02)Marketed from Sep 2, 2023
76420-599-05764200599055 TABLET, FILM COATED in 1 BOTTLE (76420-599-05)Marketed from Sep 2, 2023
76420-599-07764200599077 TABLET, FILM COATED in 1 BOTTLE (76420-599-07)Marketed from Sep 2, 2023
76420-599-1076420059910100 TABLET, FILM COATED in 1 BOTTLE (76420-599-10)Marketed from Sep 2, 2023
76420-599-147642005991414 TABLET, FILM COATED in 1 BOTTLE (76420-599-14)Marketed from Sep 2, 2023
76420-599-207642005992020 TABLET, FILM COATED in 1 BOTTLE (76420-599-20)Marketed from Sep 2, 2023
76420-599-307642005993030 TABLET, FILM COATED in 1 BOTTLE (76420-599-30)Marketed from Sep 2, 2023
76420-599-607642005996060 TABLET, FILM COATED in 1 BOTTLE (76420-599-60)Marketed from Sep 2, 2023
76420-599-907642005999090 TABLET, FILM COATED in 1 BOTTLE (76420-599-90)Marketed from Sep 2, 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 — 10 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078643
Marketing start
Listing expires
Other FDA classes
Centrally-mediated Muscle Relaxation (Physiologic effect)
Identifiers
Product ID 76420-599_04ab2bbb-1be5-1bfc-e063-6394a90a103eSPL ID 04ab2bbb-1be5-1bfc-e063-6394a90a103eSPL set ID 74af1727-e84f-4dad-82be-045e7d23beafRxCUI 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

N476420059902 followed by a unit qualifier and the quantity

Package 76420-0599-02. 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 078643

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

FDA NDC Directory listings under ANDA 078643
ProductStrengthForm · routeLabelerProduct NDC
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2110
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 5 mg/1Tablet, Film coatedOralQPharma Inc42708-172
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-191
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 5 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-190
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3764
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralMedsource Pharmaceuticals45865-244
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 5 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC82868-008
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8167
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2678
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 5 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2156
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 5 mg/1Tablet, Film coatedOralProficient Rx LP71205-678
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 5 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8221
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-0190
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 5 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7400
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3474
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7401
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralRising Pharma Holdings, Inc.16571-783
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 5 mg/1Tablet, Film coatedOralRising Pharma Holdings, Inc.16571-782
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-2659
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralRedpharm Drug67296-1893

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