16590-112 : Apap 500 mg / Hydrocodone Bitartrate 2.5 mg Oral Tablet


NDC16590-112
Labeler: Stat Rx USA LLC
Product Type: Human Prescription Drug
Drug Name: Hydrocodone Bitartrate and Acetaminophen
Dosage Form: Oral Tablet
Application #: ANDA081079
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;388
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.

WATSON 388: (0591-0388) Apap 500 mg / Hydrocodone Bitartrate 2.5 mg Oral Tablet by Stat Rx USA LLC
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:

  • 16590-112-30: 30 TABLET IN 1 BOTTLE (16590‑112‑30)
  • 16590-112-60: 60 TABLET IN 1 BOTTLE (16590‑112‑60)
  • 16590-112-72: 120 TABLET IN 1 BOTTLE (16590‑112‑72)
  • 16590-112-90: 90 TABLET IN 1 BOTTLE (16590‑112‑90)

Active Ingredients:

  • Acetaminophen
  • Hydrocodone Bitartrate

Dosage Strength:

  • 500 mg
  • 2.5 mg

Inactive Ingredients:

  • Anhydrous Lactose
  • Croscarmellose Sodium
  • Crospovidone
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Povidone
  • Starch, Pregelatinized Corn
  • Stearic Acid

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 16590-113 Apap 500 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Stat Rx USA LLC
  • 16590-114 Apap 325 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Stat Rx USA LLC
  • 16590-115 Apap 500 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Stat Rx USA LLC
  • 16590-116 Apap 650 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Stat Rx USA LLC
  • 16590-117 Apap 750 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Stat Rx USA LLC
  • 16590-118 Apap 325 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Stat Rx USA LLC
  • 16590-119 Apap 500 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Stat Rx USA LLC
  • 16590-120 Apap 650 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Stat Rx USA LLC
  • 16590-494 Apap 325 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Stat Rx USA LLC
  • 16590-875 Apap 660 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Stat Rx USA LLC
  • 42549-514 Apap 325 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Stat Rx USA LLC
  • 42549-516 Apap 500 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Stat Rx USA LLC
  • 42549-556 Apap 325 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Stat Rx USA LLC
  • 42549-557 Apap 325 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Stat Rx USA LLC
  • 42549-586 Apap 750 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Stat Rx USA LLC
  • 42549-609 Apap 500 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Stat Rx USA LLC
  • 42549-653 Apap 500 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Stat Rx USA LLC
  • 0121-0655 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Pharmaceutical Associates, Inc.
  • 0121-0772 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Pharmaceutical Associates, Inc.
  • 0121-1544 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Pharmaceutical Associates, Inc.
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NDC QR Code

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NDC 16590-112 QR Code

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