50111-563 : Cyclobenzaprine Hydrochloride 10 mg Oral Tablet


NDC50111-563
Labeler: Pliva Inc.
Product Type: Human Prescription Drug
Drug Name:  Cyclobenzaprine Hydrochloride
Dosage Form: Oral Tablet, Film Coated
Application #: ANDA074421
Rev. Date: 


Appearance:


Markings: PLIVA;563
Shapes:  Round
Colors:  Yellow
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.

PLIVA 563: (50111-563) Cyclobenzaprine Hydrochloride 10 mg Oral Tablet by Pliva Inc.
The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.

NDC Package Codes:

  • 50111-563-01: 100 TABLET, FILM COATED IN 1 BOTTLE (50111‑563‑01)
  • 50111-563-02: 500 TABLET, FILM COATED IN 1 BOTTLE (50111‑563‑02)
  • 50111-563-03: 1000 TABLET, FILM COATED IN 1 BOTTLE (50111‑563‑03)

Active Ingredients:

  • Cyclobenzaprine Hydrochloride

Dosage Strength:

  • 10 mg

Inactive Ingredients:

  • Anhydrous Lactose
  • Carnauba Wax
  • Starch, Corn
  • Crospovidone
  • Hypromellose 2910 (3 Mpa.s)
  • Hypromellose 2910 (6 Mpa.s)
  • Magnesium Stearate
  • Polyethylene Glycol 400
  • Polyethylene Glycol 8000
  • Polysorbate 80
  • Titanium Dioxide
  • D&c Yellow No. 10
  • Aluminum Oxide
  • Fd&c Blue No. 2
  • 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.
  • 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.
  • 0591-3256 Cyclobenzaprine Hydrochloride 5 mg Oral Tablet by Watson Laboratories, Inc.
  • 0591-3330 Cyclobenzaprine Hydrochloride 7.5 mg Oral Tablet by Watson Laboratories, Inc.
  • 0591-5658 Cyclobenzaprine Hydrochloride 10 mg Oral Tablet by Watson Laboratories, Inc.
  • 0603-3078 Cyclobenzaprine Hydrochloride 5 mg Oral Tablet by Qualitest Pharmaceuticals
  • 0603-3079 Cyclobenzaprine Hydrochloride 10 mg Oral Tablet by Qualitest Pharmaceuticals
  • 0615-3520 Cyclobenzaprine Hydrochloride 10 mg Oral Tablet by Ncs Healthcare of Ky, Inc Dba Vangard Labs
  • 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.