53002-0520 : Cyclobenzaprine Hydrochloride 5 mg Oral Tablet, Film Coated


NDC: 53002-0520
Labeler: Rpk Pharmaceuticals, Inc.
Product Type: Human Prescription Drug
Drug Name:  Cyclobenzaprine Hydrochloride
Dosage Form: Oral Tablet, Film Coated
Application #: ANDA078048
Rev. Date: 


Appearance:


Markings: K;6
Shapes:  Round
Colors:  Orange
Size (mm): 8
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

  • 53002-0520-1: 5 TABLET, FILM COATED IN 1 BOTTLE (53002‑0520‑1)
  • 53002-0520-2: 10 TABLET, FILM COATED IN 1 BOTTLE (53002‑0520‑2)
  • 53002-0520-3: 15 TABLET, FILM COATED IN 1 BOTTLE (53002‑0520‑3)
  • 53002-0520-4: 20 TABLET, FILM COATED IN 1 BOTTLE (53002‑0520‑4)
  • 53002-0520-5: 30 TABLET, FILM COATED IN 1 BOTTLE (53002‑0520‑5)

Active Ingredients:

  • Cyclobenzaprine Hydrochloride

Dosage Strength:

  • 5 mg

Inactive Ingredients:

  • Lactose Monohydrate
  • Microcrystalline Cellulose
  • Croscarmellose Sodium
  • Silicon Dioxide
  • Magnesium Stearate
  • Carnauba Wax
  • Titanium Dioxide
  • Polyethylene Glycol, Unspecified
  • Ferric Oxide Yellow
  • Polyvinyl Alcohol, Unspecified
  • Talc
  • Lecithin, Soybean
  • Fd&c Yellow No. 6

Pharmaceutical Classes:

  • Centrally-mediated Muscle Relaxation [PE]
  • Muscle Relaxant [EPC]

Related Products:

Based on records with the same trade name.
  • 53002-0521 Cyclobenzaprine Hydrochloride 5 mg Oral Tablet, Film Coated by Rpk Pharmaceuticals, Inc.
  • 53002-0522 Cyclobenzaprine Hydrochloride 5 mg Oral Tablet, Film Coated by Rpk Pharmaceuticals, Inc.
  • 53002-0523 Cyclobenzaprine Hydrochloride 5 mg Oral Tablet, Film Coated by Rpk Pharmaceuticals, Inc.
  • 53002-0524 Cyclobenzaprine Hydrochloride 5 mg Oral Tablet, Film Coated by Rpk Pharmaceuticals, Inc.
  • 53002-3080 Cyclobenzaprine Hydrochloride 10 mg Oral Tablet, Film Coated by Rpk Pharmaceuticals, Inc.
  • 53002-3081 Cyclobenzaprine Hydrochloride 10 mg Oral Tablet, Film Coated by Rpk Pharmaceuticals, Inc.
  • 0093-1920 Cyclobenzaprine Hydrochloride 15 mg Oral Capsule, Extended Release by Teva Pharmaceuticals USA, Inc.
  • 0093-1921 Cyclobenzaprine Hydrochloride 30 mg Oral Capsule, Extended Release by Teva Pharmaceuticals USA, Inc.
  • 0093-3420 Cyclobenzaprine Hydrochloride 5 mg Oral Tablet, Film Coated by Teva Pharmaceuticals USA, Inc.
  • 0093-3421 Cyclobenzaprine Hydrochloride 7.5 mg Oral Tablet, Film Coated by Teva Pharmaceuticals USA, Inc.
  • 0093-3422 Cyclobenzaprine Hydrochloride 10 mg Oral Tablet, Film Coated by Teva Pharmaceuticals USA, Inc.
  • 0115-1436 Cyclobenzaprine Hydrochloride 15 mg Oral Capsule, Extended Release by Impax Generics
  • 0115-1437 Cyclobenzaprine Hydrochloride 30 mg Oral Capsule, Extended Release by Impax Generics
  • 0179-0057 Cyclobenzaprine Hydrochloride 10 mg Oral Tablet by Kaiser Foundation Hospitals
  • 0179-0189 Cyclobenzaprine Hydrochloride 5 mg Oral Tablet by Kaiser Foundation Hospitals
  • 0378-0751 Cyclobenzaprine Hydrochloride 10 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0378-0761 Cyclobenzaprine Hydrochloride 7.5 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0378-0771 Cyclobenzaprine Hydrochloride 5 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0440-1350 Cyclobenzaprine Hydrochloride 10 mg Oral Tablet by Liberty Pharmaceuticals, Inc.
  • 0440-7350 Cyclobenzaprine Hydrochloride 10 mg Oral Tablet, Film Coated by Liberty Pharmaceuticals, Inc.
  • More related products ...

NDC QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.