Prescription drug · ANDA

Cyclobenzaprine Hydrochloride (Cyclobenzaprine) NDC 63187-812

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

NDC codes

FDA NDC Directory
Product NDC (as listed)63187-812Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0812Add 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
63187-812-0763187081207631870812077 TABLET, FILM COATED in 1 BOTTLE (63187-812-07)Marketed from May 14, 2021
63187-812-10631870812106318708121010 TABLET, FILM COATED in 1 BOTTLE (63187-812-10)Marketed from Aug 1, 2017
63187-812-12631870812126318708121212 TABLET, FILM COATED in 1 BOTTLE (63187-812-12)Marketed from Apr 2, 2018
63187-812-15631870812156318708121515 TABLET, FILM COATED in 1 BOTTLE (63187-812-15)Marketed from Feb 2, 2017
63187-812-20631870812206318708122020 TABLET, FILM COATED in 1 BOTTLE (63187-812-20)Marketed from Feb 2, 2017
63187-812-21631870812216318708122121 TABLET, FILM COATED in 1 BOTTLE (63187-812-21)Marketed from Feb 1, 2017
63187-812-30631870812306318708123030 TABLET, FILM COATED in 1 BOTTLE (63187-812-30)Marketed from Feb 1, 2017
63187-812-45631870812456318708124545 TABLET, FILM COATED in 1 BOTTLE (63187-812-45)Marketed from Feb 1, 2017
63187-812-60631870812606318708126060 TABLET, FILM COATED in 1 BOTTLE (63187-812-60)Marketed from Feb 1, 2017
63187-812-726318708127263187081272120 TABLET, FILM COATED in 1 BOTTLE (63187-812-72)Marketed from Feb 1, 2018
63187-812-90631870812906318708129090 TABLET, FILM COATED in 1 BOTTLE (63187-812-90)Marketed from Feb 1, 2017

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
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 090478
Marketing start
Listing expires
Other FDA classes
Centrally-mediated Muscle Relaxation (Physiologic effect)
Identifiers
Product ID 63187-812_3afe19fb-b693-47f7-a08e-a46cc756ffdaSPL ID 3afe19fb-b693-47f7-a08e-a46cc756ffdaSPL set ID ae6de8d8-33c2-40bd-9dd3-782c879a9d8fRxCUI 828348UNII 0VE05JYS2PUPC 0363187812720
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

N463187081207 followed by a unit qualifier and the quantity

Package 63187-0812-07. 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 HCl 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 HCl 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 longer per…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63187-812

What is NDC 63187-812?
63187-812 is the product NDC for Cyclobenzaprine Hydrochloride (cyclobenzaprine), Cyclobenzaprine hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 11 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Cyclobenzaprine Hydrochloride (Cyclobenzaprine).
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 090478

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

FDA NDC Directory listings under ANDA 090478
ProductStrengthForm · routeLabelerProduct NDC
Cyclobenzaprine HydrochloridecyclobenzaprineCyclobenzaprine hydrochloride 10 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-933
Cyclobenzaprine HydrochloridecyclobenzaprineCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-973
Cyclobenzaprine HydrochloridecyclobenzaprineCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-558
Cyclobenzaprine HydrochloridecyclobenzaprineCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc.68071-3150
Cyclobenzaprine HydrochloridecyclobenzaprineCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc.68071-3154
Cyclobenzaprine HydrochloridecyclobenzaprineCyclobenzaprine hydrochloride 10 mg/1TabletOralEXELAN PHARMACEUTICALS, INC.76282-283
Cyclobenzaprine HydrochloridecyclobenzaprineCyclobenzaprine hydrochloride 5 mg/1Tablet, Film coatedOralCipla USA Inc.69097-845
Cyclobenzaprine HydrochloridecyclobenzaprineCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralCipla USA Inc.69097-846
Cyclobenzaprine HydrochloridecyclobenzaprineCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8084
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 5 mg/1Tablet, Film coatedOralAvPAK50268-190
Cyclobenzaprine HydrochloridecyclobenzaprineCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralAvPAK50268-191

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in