Cyclobenzaprine Hydrochloride NDC 85534-0085

Product information

Brand name (proprietary)

Cyclobenzaprine Hydrochloride

Generic name (nonproprietary)

cyclobenzaprine hydrochloride

Active ingredients

Cyclobenzaprine hydrochloride — 7.5 mg/1

Dosage form

Tablet, Film coated

Route

Oral

Labeler

HAWAII REPACK, INC.NDC labeler code 85534

Product type

Prescription drug

Marketing category

ANDA — Abbreviated New Drug Application (generic)Application ANDA 208170

Marketing start

May 31, 2017

Listing expires

Dec 31, 2027

Other FDA classes

Centrally-mediated Muscle Relaxation (Physiologic effect)

Identifiers

Product ID 85534-0085_5b88dd9c-af33-970c-e063-6394a90a7ebbSPL ID 5b88dd9c-af33-970c-e063-6394a90a7ebb

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

N485534008500 followed by a unit qualifier and the quantity Copy

Package 85534-0085-00. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 85534-0085

What is NDC 85534-0085?

85534-0085 is the product NDC for Cyclobenzaprine Hydrochloride, Cyclobenzaprine hydrochloride 7.5 mg/1 tablet, film coated, listed with the FDA by HAWAII REPACK, INC.. 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?

HAWAII REPACK, INC., NDC labeler code 85534. 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.

Related NDCs: other Cyclobenzaprine Hydrochloride products

Other finished products listed under the same name: strengths, forms and labelers.

All 222 Cyclobenzaprine Hydrochloride NDCs

Other NDCs under ANDA 208170

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

Showing 20 of 39.