NDC codes

FDA NDC Directory
Product NDC (as listed)71335-1962Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-1962Add 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
71335-1962-07133519620040 TABLET, FILM COATED in 1 BOTTLE (71335-1962-0)Marketed from Feb 14, 2022
71335-1962-17133519620114 TABLET, FILM COATED in 1 BOTTLE (71335-1962-1)Marketed from Oct 11, 2021
71335-1962-27133519620284 TABLET, FILM COATED in 1 BOTTLE (71335-1962-2)Marketed from Feb 14, 2022
71335-1962-37133519620330 TABLET, FILM COATED in 1 BOTTLE (71335-1962-3)Marketed from Oct 8, 2021
71335-1962-47133519620420 TABLET, FILM COATED in 1 BOTTLE (71335-1962-4)Marketed from Oct 8, 2021
71335-1962-57133519620515 TABLET, FILM COATED in 1 BOTTLE (71335-1962-5)Marketed from Dec 30, 2021
71335-1962-67133519620660 TABLET, FILM COATED in 1 BOTTLE (71335-1962-6)Marketed from Oct 8, 2021
71335-1962-77133519620790 TABLET, FILM COATED in 1 BOTTLE (71335-1962-7)Marketed from Oct 8, 2021
71335-1962-87133519620856 TABLET, FILM COATED in 1 BOTTLE (71335-1962-8)Marketed from Feb 14, 2022
71335-1962-971335196209120 TABLET, FILM COATED in 1 BOTTLE (71335-1962-9)Marketed from Nov 16, 2021

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 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 213324
Marketing start
Listing expires
Other FDA classes
Centrally-mediated Muscle Relaxation (Physiologic effect)
Identifiers
Product ID 71335-1962_081b5e7c-a504-8d76-e063-6294a90a821fSPL ID 081b5e7c-a504-8d76-e063-6294a90a821fSPL set ID 4a2d3cae-5c64-4986-9707-cc213b70b7adRxCUI 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

N471335196200 followed by a unit qualifier and the quantity

Package 71335-1962-00. 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 213324

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

FDA NDC Directory listings under ANDA 213324
ProductStrengthForm · routeLabelerProduct NDC
Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochloride 5 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8508
Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochloride 7.5 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-256
Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochloride 5 mg/1Tablet, Film coatedOralSportpharm LLC85766-272
Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochloride 7.5 mg/1Tablet, Film coatedOralSportpharm LLC85766-273
Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralSportpharm LLC85766-274
Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochloride 7.5 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4265
Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochloride 5 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3251
Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochloride 7.5 mg/1Tablet, Film coatedOralSt. Mary's Medical Park Pharmacy60760-780
Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralPHOENIX RX LLC85509-1415
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-3404
Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8637
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 5 mg/1Tablet, Film coatedOralDirectRx72189-280
Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochloride 5 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1961
Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochloride 7.5 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-2471
Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5711
Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5712
Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5713
Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochloride 7.5 mg/1Tablet, Film coatedOralUnichem Pharmaceuticals (USA), Inc.29300-414
Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochloride 5 mg/1Tablet, Film coatedOralUnichem Pharmaceuticals (USA), Inc.29300-413
Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochloride 5 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-839

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