What is NDC 68788-8167?

68788-8167 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.

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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Cyclobenzaprine Hydrochloride NDC 68788-8167

NDC codes

FDA NDC Directory

Product NDC (as listed)68788-8167Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68788-8167Add 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 NDC	11-digit (billing)	Package
68788-8167-2	6878881670268788816702	20 TABLET, FILM COATED in 1 BOTTLE (68788-8167-2)Marketed from Apr 8, 2022
68788-8167-3	6878881670368788816703	30 TABLET, FILM COATED in 1 BOTTLE (68788-8167-3)Marketed from Apr 8, 2022
68788-8167-5	6878881670568788816705	15 TABLET, FILM COATED in 1 BOTTLE (68788-8167-5)Marketed from Apr 8, 2022
68788-8167-6	6878881670668788816706	60 TABLET, FILM COATED in 1 BOTTLE (68788-8167-6)Marketed from Apr 8, 2022
68788-8167-9	6878881670968788816709	90 TABLET, FILM COATED in 1 BOTTLE (68788-8167-9)Marketed from Apr 8, 2022

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 078643
Marketing start: Apr 8, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Centrally-mediated Muscle Relaxation (Physiologic effect)
Identifiers: Product ID 68788-8167_6e52b30a-3a9c-47cf-a088-707511645d5bSPL ID 6e52b30a-3a9c-47cf-a088-707511645d5bSPL set ID 014dd648-5b84-4d1d-80fc-a467e2d741efRxCUI 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

N468788816702 followed by a unit qualifier and the quantity

Package 68788-8167-02. 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 Apr 1, 2026.

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, USP 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 a…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68788-8167

What is NDC 68788-8167?: 68788-8167 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 7.5 mg/1	Tablet, Film coatedOral	Carol Way Pharma LLC	85437-013	85437-0013-10
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 7.5 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4751	70518-4751-00
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 10 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-4154	68788-4154-0268788-4154-0368788-4154-05+2 more
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 10 mg/1	TabletOral	REMEDYREPACK INC.	70518-4692	70518-4692-0070518-4692-0170518-4692-02
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 10 mg/1	Tablet, Film coatedOral	Unit Dose Solutions, Inc.	87441-010	87441-0010-01
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 5 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1110	67046-1110-03
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 15 mg/1	Capsule, Extended releaseOral	Preferred Pharmaceuticals Inc.	68788-4087	68788-4087-0368788-4087-06
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 5 mg/1	Tablet, Film coatedOral	Medcore LLC	82461-714	82461-0714-90
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 10 mg/1	Tablet, Film coatedOral	Medcore LLC	82461-716	82461-0716-90
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 10 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1645	67046-1645-03

All 222 Cyclobenzaprine Hydrochloride NDCs

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
Product	Strength	Form · route	Labeler	Product NDC
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 5 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-7400
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 10 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-7401
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 5 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	16571-782
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 10 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	16571-783
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 5 mg/1	Tablet, Film coatedOral	QPharma Inc	42708-172
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 10 mg/1	Tablet, Film coatedOral	Medsource Pharmaceuticals	45865-244
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 10 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-0190
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 10 mg/1	Tablet, Film coatedOral	Redpharm Drug	67296-1893
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 10 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-2659
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 5 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-2790
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 5 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8221
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 10 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3474
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 10 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3764
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 5 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-678
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 10 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2110
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 5 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2156
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 10 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2678
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 10 mg/1	Tablet, Film coatedOral	Asclemed USA, Inc.	76420-599
Cyclobenzaprine Hydrochloride	Cyclobenzaprine hydrochloride 5 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	82868-008