Prescription drug · ANDA

Cyclobenzaprine Hydrochloride NDC 76420-895

Cyclobenzaprine hydrochloride 15 mg/1 · Capsule, Extended release · Oral · Asclemed USA, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)76420-895Labeler and product segments. Claims need a package NDC.
Product NDC at billing width76420-0895Add 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
76420-895-017642008950176420089501100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-895-01)Marketed from Jan 7, 2025
76420-895-30764200895307642008953030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-895-30)Marketed from Jan 7, 2025
76420-895-60764200895607642008956060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-895-60)Marketed from Jan 7, 2025
76420-895-90764200895907642008959090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-895-90)Marketed from Jan 7, 2025

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
Labeler
Asclemed USA, Inc.NDC labeler code 76420
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 76420-895_2b1fe790-9c6e-85ed-e063-6294a90a6471SPL ID 2b1fe790-9c6e-85ed-e063-6294a90a6471SPL set ID 3dd2bde1-f06d-493a-91c7-22b28a5e1699RxCUI 828353, 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

N476420089501 followed by a unit qualifier and the quantity

Package 76420-0895-01. 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)

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 therapy…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76420-895

What is NDC 76420-895?
76420-895 is the product NDC for Cyclobenzaprine Hydrochloride, Cyclobenzaprine hydrochloride 15 mg/1 capsule, extended release, listed with the FDA by Asclemed USA, 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?
Asclemed USA, Inc., NDC labeler code 76420. 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/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-415468788-4154-0268788-4154-0368788-4154-05+2 more
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

All 222 Cyclobenzaprine Hydrochloride NDCs

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 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 releaseOralPreferred Pharmaceuticals, Inc.68788-8522
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 15 mg/1Capsule, Extended releaseOralREMEDYREPACK INC.70518-4225
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 releaseOralProficient Rx LP71205-857
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 30 mg/1Capsule, Extended releaseOralProficient Rx LP71205-858
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 15 mg/1Capsule, Extended releaseOralBryant Ranch Prepack71335-2514
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 15 mg/1Capsule, Extended releaseOralDIRECT RX72189-101
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 30 mg/1Capsule, Extended releaseOralAsclemed USA, Inc.76420-896
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 15 mg/1Capsule, Extended releaseOralAdvanced Rx of Tennessee, LLC80425-0460
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 15 mg/1Capsule, Extended releaseOralPHOENIX RX LLC85509-1035

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