43063-753 : Buprenorphine Hcl 8 mg Sublingual Tablet


NDC43063-753
Labeler: Pd-rx Pharmaceuticals, Inc.
Product Type: Human Prescription Drug
Drug Name:  Buprenorphine Hcl
Dosage Form: Sublingual Tablet
Application #: ANDA078633
Rev. Date: 
CSA Schedule: CIII (US) [1]


[1] Schedule III / IIIN Controlled Substance: Has a potential for abuse less than substances in Schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence. (i.e. Products containing not more than 90 milligrams of Codeine per dosage unit [such as Tylenol with Codeine], other narcotics such as Buprenorphine (Suboxone), and Schedule IIIN non-narcotics such as Didrex, Ketamine, Phendimetrazine, and Anabolic Steroids). More Details: US Dept of Justice Controlled Substance Schedules.

Appearance:


Markings: 54;411
Shapes:  Round
Colors:  White
Size (mm): 10
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.

54 411: (0054-0177) Buprenorphine Hcl 8 mg Sublingual Tablet by Pd-rx Pharmaceuticals, 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:

  • 43063-753-06: 9 TABLET IN 1 BOTTLE, PLASTIC (43063‑753‑06)

Active Ingredients:

  • Buprenorphine Hydrochloride

Dosage Strength:

  • 8 mg

Inactive Ingredients:

  • Anhydrous Citric Acid
  • Starch, Corn
  • Crospovidone (15 Mpa.s At 5%)
  • Lactose Monohydrate
  • Magnesium Stearate
  • Mannitol
  • Povidones
  • Sodium Citrate, Unspecified Form

Pharmaceutical Classes:

  • Partial Opioid Agonist [EPC]
  • Partial Opioid Agonists [MoA]

Related Products:

Based on records with the same trade name.
  • 0054-0176 Buprenorphine 2 mg (As Buprenorphine Hydrochloride 2.16 mg) Sublingual Tablet by Roxane Laboratories, Inc
  • 0054-0177 Buprenorphine 8 mg (As Buprenorphine Hydrochloride 8.64 mg) Sublingual Tablet by Roxane Laboratories, Inc
  • 0904-7154 Buprenorphine Hcl 2 mg Sublingual Tablet by Major Pharmaceuticals
  • 0904-7155 Buprenorphine Hcl 8 mg Sublingual Tablet by Major Pharmaceuticals
  • 55154-4962 Buprenorphine 2 mg (As Buprenorphine Hydrochloride 2.16 mg) Sublingual Tablet by Cardinal Health
  • 55700-302 Buprenorphine Hcl 2 mg Sublingual Tablet by Lake Erie Medical Dba Quality Care Products LLC
  • 55700-303 Buprenorphine Hcl 8 mg Sublingual Tablet by Lake Erie Medical Dba Quality Care Products LLC
  • 58118-0176 Buprenorphine Hcl 2 mg Sublingual Tablet by Clinical Solutions Wholesale, LLC
  • 58118-0177 Buprenorphine Hcl 8 mg Sublingual Tablet by Clinical Solutions Wholesale, LLC
  • 67046-998 Buprenorphine Hcl 2 mg Sublingual Tablet by Contract Pharmacy Services-pa
  • 67046-999 Buprenorphine Hcl 8 mg Sublingual Tablet by Contract Pharmacy Services-pa
  • 68071-2915 Buprenorphine Hcl 8 mg Sublingual Tablet by Nucare Pharmaceuticals, Inc.
  • 70518-2014 Buprenorphine Hcl 8 mg Sublingual Tablet by Remedyrepack Inc.
  • 70518-2226 Buprenorphine Hcl 2 mg Sublingual Tablet by Remedyrepack Inc.
  • 71335-1163 Buprenorphine Hcl 8 mg Sublingual Tablet by Bryant Ranch Prepack

NDC QR Code

Scan the QR code below to easily reference this data in the future:

NDC 43063-753 QR Code

< Prev: 43063-752Next: 43063-754 >

Related Discussions:

buprenorphine 8mg 460
I have been prescribed the 54 411 buprenorphine pills for about 7 years now. After my last doc visit I filled my script ... 45 replies
Buprenorphine for Treatment Resistant Depression
Has anyone any experience taking this medication and has it helped for your Depression? I realize this is not yet consid... 42 replies
BUPRENORPHINE OR METHADONE
WHICH IS BETTER? I have been on a dose of 150mg of Methadone for approx. 8 or so years. I just recently heard of this dr... 33 replies
Buprenorphine 8mg Tablet Comparisons
Is there a difference between 54 411 tablets and the orange half moon subutex? My son seems to think the 54 411 makes hi... 19 replies
Buprenorphine by Roxanne labs Pgh Pa
Can not find pharmacy again that has 8 mg buprenorphine by Roxanne Labs. Have a prescription but can not find a place to... 15 replies
Buprenorphine + Naloxone / Suboxone 8mg-2mg
I took this medicine to get off of Hydrocodone. I don't even take a quarter of a whole one a day. I usually take a s... 9 replies
Buprenorphine 8mg vs 8.2mg tablets
What is the difference between buprenorphine 8 mg and 8.2 mg? Thank you. ## There is a medication called Subutex that so... 7 replies
Buprenorphine 8mg white pill 460
I just took this pill from sun pharmacies and it had this mint like burn to it... If u are not allergic to suboxone can ... 6 replies
Buprenorphine Availability In Florida
I've been prescribed buprenorphine for long acting pain management as well as Medication Assisted Treatment for 3 ye... 6 replies
buprenorphine hydrochloride for pain
They have me on buprenorphine for chronic pain ## Hello, Mike! How are you? Have you tried it, yet? The FDA does classif... 5 replies




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.