Prescription drug · ANDA

Cyclobenzaprine Hydrochloride NDC 71205-857

Cyclobenzaprine hydrochloride 15 mg/1 · Capsule, Extended release · Oral · Proficient Rx LP

NDC codes

FDA NDC Directory
Product NDC (as listed)71205-857Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71205-0857Add 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
71205-857-0071205085700100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-857-00)Marketed from May 6, 2022
71205-857-11712050857111000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-857-11)Marketed from May 6, 2022
71205-857-307120508573030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-857-30)Marketed from May 6, 2022
71205-857-5571205085755500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-857-55)Marketed from May 6, 2022
71205-857-607120508576060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-857-60)Marketed from May 6, 2022
71205-857-7271205085772120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-857-72)Marketed from May 6, 2022
71205-857-907120508579090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-857-90)Marketed from May 6, 2022

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 hydrochloride
Active ingredients
Cyclobenzaprine hydrochloride — 15 mg/1
Dosage form
Capsule, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091281
Marketing start
Listing expires
Other FDA classes
Centrally-mediated Muscle Relaxation (Physiologic effect)
Identifiers
Product ID 71205-857_ffd82a69-a64c-4399-8f5d-bddc70cdc3cfSPL ID ffd82a69-a64c-4399-8f5d-bddc70cdc3cfSPL set ID ffd82a69-a64c-4399-8f5d-bddc70cdc3cfRxCUI 828353, 828358UNII 0VE05JYS2PUPC 0371205857301, 0371205858308
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

N471205085700 followed by a unit qualifier and the quantity

Package 71205-0857-00. 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

Current FDA label (SPL), effective .

Indications (excerpt from the label)

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 duration and specific thera…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 091281

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

FDA NDC Directory listings under ANDA 091281
ProductStrengthForm · routeLabelerProduct NDC
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 30 mg/1Capsule, Extended releaseOralProficient Rx LP71205-858
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 15 mg/1Capsule, Extended releaseOralREMEDYREPACK INC.70518-4225
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 15 mg/1Capsule, Extended releaseOralUpsher-Smith Laboratories, LLC24979-035
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 30 mg/1Capsule, Extended releaseOralUpsher-Smith Laboratories, LLC24979-036
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 15 mg/1Capsule, Extended releaseOralDIRECT RX72189-101
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 15 mg/1Capsule, Extended releaseOralAdvanced Rx of Tennessee, LLC80425-0460
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 15 mg/1Capsule, Extended releaseOralPreferred Pharmaceuticals, Inc.68788-8522
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 15 mg/1Capsule, Extended releaseOralPHOENIX RX LLC85509-1035
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 30 mg/1Capsule, Extended releaseOralREMEDYREPACK INC.70518-4523
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 15 mg/1Capsule, Extended releaseOralProficient Rx LP71205-454
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 15 mg/1Capsule, Extended releaseOralBryant Ranch Prepack71335-2514
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 15 mg/1Capsule, Extended releaseOralAsclemed USA, Inc.76420-895
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 30 mg/1Capsule, Extended releaseOralAsclemed USA, Inc.76420-896

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