Prescription drug · ANDA

Cyclobenzaprine Hydrochloride NDC 68788-4154

Cyclobenzaprine hydrochloride 10 mg/1 · Tablet, Film coated · Oral · Preferred Pharmaceuticals Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)68788-4154Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-4154Add 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
68788-4154-2687884154026878841540220 TABLET, FILM COATED in 1 BOTTLE (68788-4154-2)Marketed from Jul 15, 2026
68788-4154-3687884154036878841540330 TABLET, FILM COATED in 1 BOTTLE (68788-4154-3)Marketed from Jul 15, 2026
68788-4154-5687884154056878841540515 TABLET, FILM COATED in 1 BOTTLE (68788-4154-5)Marketed from Jul 15, 2026
68788-4154-6687884154066878841540660 TABLET, FILM COATED in 1 BOTTLE (68788-4154-6)Marketed from Jul 15, 2026
68788-4154-9687884154096878841540990 TABLET, FILM COATED in 1 BOTTLE (68788-4154-9)Marketed from Jul 15, 2026

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
Labeler
Preferred Pharmaceuticals Inc.NDC labeler code 68788
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077563
Marketing start
Listing expires
Other FDA classes
Centrally-mediated Muscle Relaxation (Physiologic effect)
Identifiers
Product ID 68788-4154_84be93c5-1526-465e-ab0b-c6d10ba1521dSPL ID 84be93c5-1526-465e-ab0b-c6d10ba1521dSPL set ID 84be93c5-1526-465e-ab0b-c6d10ba1521dRxCUI 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

N468788415402 followed by a unit qualifier and the quantity

Package 68788-4154-02. 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

Current FDA label (SPL), effective .

Indications (excerpt from the label)

INDICATIONS AND USAGE Cyclobenzaprine hydrochloride 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 hydrochloride tablets should be used only for short periods (up to 2 or 3 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68788-4154

What is NDC 68788-4154?
68788-4154 is the product NDC for Cyclobenzaprine Hydrochloride, Cyclobenzaprine hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 5 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?
Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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/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
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 30 mg/1Capsule, Extended releaseOralREMEDYREPACK INC.70518-452370518-4523-00

All 222 Cyclobenzaprine Hydrochloride NDCs

Other NDCs under ANDA 077563

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

FDA NDC Directory listings under ANDA 077563
ProductStrengthForm · routeLabelerProduct NDC
Cyclobenzaprine HCLCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralDirect_Rx72189-680
Cyclobenzaprine HCLCyclobenzaprine hydrochloride 5 mg/1Tablet, Film coatedOralAdvanced Rx of Tennessee, LLC80425-0017
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralAvKARE42291-154
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralJubilant Cadista Pharmaceuticals Inc.59746-177
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 5 mg/1Tablet, Film coatedOralJubilant Cadista Pharmaceuticals Inc.59746-211
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 7.5 mg/1Tablet, Film coatedOralJubilant Cadista Pharmaceuticals Inc.59746-735
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 5 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-2424
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralCoupler LLC67046-1645
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralDoc Rx69306-872
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 7.5 mg/1Tablet, Film coatedOralSA3, LLC69420-1001
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralSOLA Pharmaceuticals, LLC70512-872
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-907
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 5 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-1692
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralAdvanced Rx of Tennessee, LLC80425-0547

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