NDC codes

FDA NDC Directory
Product NDC (as listed)63187-157Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0157Add 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
63187-157-10631870157106318701571010 TABLET, FILM COATED in 1 BOTTLE (63187-157-10)Marketed from Sep 1, 2014
63187-157-20631870157206318701572020 TABLET, FILM COATED in 1 BOTTLE (63187-157-20)Marketed from Sep 1, 2014
63187-157-30631870157306318701573030 TABLET, FILM COATED in 1 BOTTLE (63187-157-30)Marketed from Sep 1, 2014
63187-157-90631870157906318701579090 TABLET, FILM COATED in 1 BOTTLE (63187-157-90)Marketed from Sep 1, 2014

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
Labeler
Proficient Rx LPNDC labeler code 63187
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078218
Marketing start
Listing expires
Other FDA classes
Centrally-mediated Muscle Relaxation (Physiologic effect)
Identifiers
Product ID 63187-157_008d1180-1d6e-4ed2-950d-c494700dd7a1SPL ID 008d1180-1d6e-4ed2-950d-c494700dd7a1SPL set ID 50aa421f-1d73-4b43-8528-2617ef2507dcRxCUI 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

N463187015710 followed by a unit qualifier and the quantity

Package 63187-0157-10. 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 is 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 should be used only for short periods (up to two or three 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 therapy for lon…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63187-157

What is NDC 63187-157?
63187-157 is the product NDC for Cyclobenzaprine Hydrochloride, Cyclobenzaprine hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Cyclobenzaprine Hydrochloride.
What is the active ingredient?
Cyclobenzaprine hydrochloride.
Who is the labeler?
Proficient Rx LP, NDC labeler code 63187. 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 Hydrochloride?
221 other product NDCs are listed under this name. See all Cyclobenzaprine Hydrochloride 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 Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 7.5 mg/1Tablet, Film coatedOralCarol Way Pharma LLC85437-01385437-0013-10
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 7.5 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-475170518-4751-00
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-415468788-4154-0268788-4154-0368788-4154-05+2 more
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1TabletOralREMEDYREPACK INC.70518-469270518-4692-0070518-4692-0170518-4692-02
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralUnit Dose Solutions, Inc.87441-01087441-0010-01
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 5 mg/1Tablet, Film coatedOralCoupler LLC67046-111067046-1110-03
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 15 mg/1Capsule, Extended releaseOralPreferred Pharmaceuticals Inc.68788-408768788-4087-0368788-4087-06
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 5 mg/1Tablet, Film coatedOralMedcore LLC82461-71482461-0714-90
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralMedcore LLC82461-71682461-0716-90
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralCoupler LLC67046-164567046-1645-03

All 222 Cyclobenzaprine Hydrochloride NDCs

Other NDCs under ANDA 078218

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

FDA NDC Directory listings under ANDA 078218
ProductStrengthForm · routeLabelerProduct NDC
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 5 mg/1Tablet, Film coatedOralAmneal Pharmaceuticals of New York LLC53746-540
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralAmneal Pharmaceuticals of New York LLC53746-541
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 5 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Inc.62332-646
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Inc.62332-647
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 7.5 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Inc.62332-649
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 5 mg/1Tablet, Film coatedOralAmneal Pharmaceuticals LLC65162-540
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralAmneal Pharmaceuticals LLC65162-541

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