43063-339 : Apap 325 mg / Hydrocodone Bitartrate 10 mg Oral Tablet


NDC43063-339
Labeler: Pd-rx Pharmaceuticals, Inc.
Product Type: Human Prescription Drug
Drug Name:  Hydrocodone Bitartrate and Acetaminophen
Dosage Form: Oral Tablet
Application #: ANDA040148
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: WATSON;853
Shapes:  Oval
Colors:  Yellow
Size (mm): 14
Segments: * 2

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 2 indicates a scored pill which can be broken into 2 equal pieces.

WATSON 853: (0591-0853) Apap 325 mg / Hydrocodone Bitartrate 10 mg Oral 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:

  • 43063-339-01: 100 TABLET IN 1 BOTTLE, PLASTIC (43063‑339‑01)
  • 43063-339-20: 20 TABLET IN 1 BOTTLE, PLASTIC (43063‑339‑20)
  • 43063-339-30: 30 TABLET IN 1 BOTTLE, PLASTIC (43063‑339‑30)
  • 43063-339-60: 60 TABLET IN 1 BOTTLE, PLASTIC (43063‑339‑60)
  • 43063-339-90: 90 TABLET IN 1 BOTTLE, PLASTIC (43063‑339‑90)
  • 43063-339-98: 120 TABLET IN 1 BOTTLE, PLASTIC (43063‑339‑98)

Active Ingredients:

  • Acetaminophen
  • Hydrocodone Bitartrate

Dosage Strength:

  • 325 mg
  • 10 mg

Inactive Ingredients:

  • Croscarmellose Sodium
  • Crospovidone
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Povidone
  • Starch, Pregelatinized Corn
  • Stearic Acid
  • D&c Yellow No. 10
  • Aluminum Oxide

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 43063-004 Apap 500 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 43063-091 Apap 325 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 43063-265 Apap 325 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 43063-327 Apap 325 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 43063-338 Apap 750 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 43063-355 Apap 500 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 43063-356 Apap 750 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 43063-357 Apap 500 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 43063-359 Apap 500 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 43063-360 Apap 500 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 43063-361 Apap 650 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 43063-363 Apap 500 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 43063-375 Apap 500 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 43063-461 Apap 500 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 43063-685 Hydrocodone Bitartrate and Acetaminophen Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 43063-686 Hydrocodone Bitartrate and Acetaminophen Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 43063-749 Hydrocodone Bitartrate and Acetaminophen Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 55289-137 Apap 500 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 55289-268 Apap 500 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 55289-311 Apap 650 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • More related products ...

NDC QR Code

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NDC 43063-339 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.