Prescription drug · NDA AUTHORIZED GENERIC

Cyclobenzaprine HCL ER (cyclobenzaprine hcl) NDC 80425-0292

Cyclobenzaprine hydrochloride 15 mg/1 · Capsule, Extended release · Oral · Advanced Rx Pharmacy of Tennessee, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)80425-0292Labeler and product segments. Claims need a package NDC.
Product NDC at billing width80425-0292Add 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
80425-0292-18042502920130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0292-1)Marketed from Mar 31, 2023
80425-0292-28042502920260 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0292-2)Marketed from Mar 31, 2023
80425-0292-38042502920390 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0292-3)Marketed from Mar 31, 2023

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 HCL ERSuffix: ER
Generic name (nonproprietary)
cyclobenzaprine hcl
Active ingredients
Cyclobenzaprine hydrochloride — 15 mg/1
Dosage form
Capsule, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 021777
Marketing start
Listing expires
Other FDA classes
Centrally-mediated Muscle Relaxation (Physiologic effect)
Identifiers
Product ID 80425-0292_2a9bfe6a-6d67-b262-e063-6294a90a1cf3SPL ID 2a9bfe6a-6d67-b262-e063-6294a90a1cf3SPL set ID f8360da5-f1d3-1d89-e053-6294a90ad31cRxCUI 828358UNII 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

N480425029201 followed by a unit qualifier and the quantity

Package 80425-0292-01. 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)

1. Indications and Usage Cyclobenzaprine hydrochloride extended-release capsules 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, and limitation of motion. Limitations of Use: Cyclobenzaprine hydrochloride extended-release capsules 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 dura…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 021777

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

FDA NDC Directory listings under NDA 021777
ProductStrengthForm · routeLabelerProduct NDC
Cyclobenzaprine HCL ERCyclobenzaprine hydrochloride 15 mg/1Capsule, Extended releaseOralDirect_Rx72189-389
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 15 mg/1Capsule, Extended releaseOralAdvanced Rx of Tennessee, LLC80425-0451
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 15 mg/1Capsule, Extended releaseOralREMEDYREPACK INC.70518-4246
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 30 mg/1Capsule, Extended releaseOralBryant Ranch Prepack71335-2696
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 15 mg/1Capsule, Extended releaseOralTeva Pharmaceuticals USA, Inc.0093-1920
Amrixcyclobenzaprine hydrochlorideCyclobenzaprine hydrochloride 15 mg/1Capsule, Extended releaseOralCephalon, LLC63459-700
Amrixcyclobenzaprine hydrochlorideCyclobenzaprine hydrochloride 30 mg/1Capsule, Extended releaseOralCephalon, LLC63459-701
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 15 mg/1Capsule, Extended releaseOralPHOENIX RX LLC85509-1920
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 30 mg/1Capsule, Extended releaseOralTeva Pharmaceuticals USA, Inc.0093-1921
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 15 mg/1Capsule, Extended releaseOralPreferred Pharmaceuticals Inc.68788-4087
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 15 mg/1Capsule, Extended releaseOralAmneal Pharmaceuticals of New York LLC0115-1436
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 30 mg/1Capsule, Extended releaseOralAmneal Pharmaceuticals of New York LLC0115-1437
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 30 mg/1Capsule, Extended releaseOralREMEDYREPACK INC.70518-4174
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 15 mg/1Capsule, Extended releaseOralBryant Ranch Prepack63629-8206
Cyclobenzaprine HCL ERCyclobenzaprine hydrochloride 15 mg/1Capsule, Extended releaseOralDirect_Rx72189-362
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 15 mg/1Capsule, Extended releaseOralDoc Rx69306-015

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in