0591-2609 : Apap 500 mg / Hydrocodone Bitartrate 10 mg Oral Tablet


NDC0591-2609
Labeler: Watson Laboratories, 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;540
Shapes:  Oval
Colors:  White
Size (mm): 15
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.

NDC Package Codes:

  • 0591-2609-01: 100 TABLET IN 1 BOTTLE, PLASTIC (0591‑2609‑01)
  • 0591-2609-05: 500 TABLET IN 1 BOTTLE, PLASTIC (0591‑2609‑05)

Active Ingredients:

  • Acetaminophen
  • Hydrocodone Bitartrate

Dosage Strength:

  • 500 mg
  • 10 mg

Inactive Ingredients:

  • Croscarmellose Sodium
  • Crospovidone
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Povidones
  • Starch, Corn
  • Stearic Acid

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 0591-0349 Apap 500 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Watson Laboratories, Inc.
  • 0591-0385 Apap 500 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Watson Laboratories, Inc.
  • 0591-0387 Apap 750 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Watson Laboratories, Inc.
  • 0591-0388 Apap 500 mg / Hydrocodone Bitartrate 2.5 mg Oral Tablet by Watson Laboratories, Inc.
  • 0591-0502 Apap 650 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Watson Laboratories, Inc.
  • 0591-0503 Apap 650 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Watson Laboratories, Inc.
  • 0591-0517 Apap 660 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Watson Laboratories, Inc.
  • 0591-0540 Apap 500 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Watson Laboratories, Inc.
  • 0591-0853 Apap 325 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Watson Laboratories, Inc.
  • 0591-2605 Apap 325 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Watson Laboratories, Inc.
  • 0591-2607 Apap 750 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Watson Laboratories, Inc.
  • 0591-2610 Apap 650 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Watson Laboratories, Inc.
  • 0591-2611 Apap 650 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Watson Laboratories, Inc.
  • 0591-2612 Apap 325 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Watson Laboratories, Inc.
  • 0591-3203 Apap 325 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Watson Laboratories, Inc.
  • 0591-3228 Apap 750 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Watson Laboratories, Inc.
  • 0591-2172 Hydrocodone Bitartrate and Acetaminophen Oral Tablet by Actavis Pharma, Inc.
  • 0591-2174 Hydrocodone Bitartrate and Acetaminophen Oral Tablet by Actavis Pharma, Inc.
  • 0591-2175 Hydrocodone Bitartrate and Acetaminophen Oral Tablet by Actavis Pharma, Inc.
  • 0591-2176 Hydrocodone Bitartrate and Acetaminophen Oral Tablet by Actavis Pharma, Inc.
  • More related products ...

NDC QR Code

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NDC 0591-2609 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.