61919-901 : Cyclobenzaprine Hcl 5 mg Oral Tablet, Film Coated


NDC61919-901
Labeler: Directrx
Product Type: Human Prescription Drug
Drug Name:  Cyclobenzaprine Hcl
Dosage Form: Oral Tablet, Film Coated
Application #: ANDA077797
Rev. Date: 


Appearance:


Markings: 2631;V
Shapes:  Round
Colors:  Orange
Size (mm): 7
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.

2631 V: (0603-3078) Cyclobenzaprine Hcl 5 mg Oral Tablet, Film Coated by Directrx
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:

  • 61919-901-15: 15 TABLET, FILM COATED IN 1 BOTTLE (61919‑901‑15)
  • 61919-901-20: 20 TABLET, FILM COATED IN 1 BOTTLE (61919‑901‑20)
  • 61919-901-30: 30 TABLET, FILM COATED IN 1 BOTTLE (61919‑901‑30)
  • 61919-901-45: 45 TABLET, FILM COATED IN 1 BOTTLE (61919‑901‑45)
  • 61919-901-60: 60 TABLET, FILM COATED IN 1 BOTTLE (61919‑901‑60)
  • 61919-901-82: 180 TABLET, FILM COATED IN 1 BOTTLE (61919‑901‑82)
  • 61919-901-90: 90 TABLET, FILM COATED IN 1 BOTTLE (61919‑901‑90)

Active Ingredients:

  • Cyclobenzaprine Hydrochloride

Dosage Strength:

  • 5 mg

Inactive Ingredients:

  • Lactose Monohydrate
  • Polyethylene Glycol, Unspecified
  • Magnesium Stearate
  • Croscarmellose Sodium
  • Cellulose, Microcrystalline
  • Fd&c Yellow No. 6
  • Hypromelloses
  • Titanium Dioxide
  • Fd&c Red No. 40 /
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Polyethylene Glycol, Unspecified
  • Fd&c Red No. 40
  • Croscarmellose Sodium
  • Hypromelloses
  • Titanium Dioxide
  • Fd&c Yellow No. 6
  • Lactose Monohydrate /
  • Polyethylene Glycol, Unspecified
  • Croscarmellose Sodium
  • Fd&c Yellow No. 6
  • Cellulose, Microcrystalline
  • Titanium Dioxide
  • Fd&c Red No. 40
  • Hypromelloses
  • Lactose Monohydrate
  • Magnesium Stearate /

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 69584-148 Cyclobenzaprine Hcl 5 mg Oral Tablet, Film Coated by Oxford Pharmaceuticals, LLC
  • 69584-149 Cyclobenzaprine Hcl 10 mg Oral Tablet, Film Coated by Oxford Pharmaceuticals, LLC
  • 80425-0015 Cyclobenzaprine Hcl 7.5 mg Oral Tablet, Film Coated by Advanced Rx Pharmacy of Tennessee, LLC
  • 80425-0016 Cyclobenzaprine Hcl 5 mg Oral Tablet, Film Coated by Advanced Rx Pharmacy of Tennessee, LLC
  • 80425-0017 Cyclobenzaprine Hcl 5 mg Oral Tablet, Film Coated by Advanced Rx Pharmacy of Tennessee, LLC
  • 80425-0018 Cyclobenzaprine Hcl 10 mg Oral Tablet, Film Coated by Advanced Rx Pharmacy of Tennessee, LLC
  • 80425-0078 Cyclobenzaprine Hcl 7.5 mg Oral Tablet, Film Coated by Advanced Rx Pharmacy of Tennessee, LLC
  • 80425-0155 Cyclobenzaprine Hcl 5 mg Oral Tablet, Film Coated by Advanced Rx Pharmacy of Tennessee, LLC

NDC QR Code

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NDC 61919-901 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.