43063-349 : Hydrocodone Bitartrate 7.5 mg / Ibuprofen 200 mg Oral Tablet


NDC43063-349
Labeler: Pd-rx Pharmaceuticals, Inc.
Product Type: Human Prescription Drug
Drug Name:  Hydrocodone Bitartrate and Ibuprofen
Dosage Form: Oral Tablet, Film Coated
Application #: ANDA076604
Rev. Date: 
CSA Schedule: CII (US) [1]


[1] Schedule II / IIN Controlled Substance: High potential for abuse which may lead to severe psychological or physical dependence. (i.e. Narcotics such as Dilaudid, Methadone, Demerol, Oxycodone, Percocet, Fentanyl, Morphine, Opium, Codeine, and Hydrocodone ... Schedule IIN stimulants include non-narcotic Amphetamines such as Dexedrine, Adderall, Desoxyn, Methylphenidate (Ritalin) ... Other Schedule II substances include Amobarbital, Glutethimide, and Pentobarbital. More Details: US Dept of Justice Controlled Substance Schedules.

Appearance:


Markings: 524
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.

524: (62037-524) Hydrocodone Bitartrate 7.5 mg / Ibuprofen 200 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:

  • 43063-349-15: 15 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (43063‑349‑15)
  • 43063-349-20: 20 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (43063‑349‑20)
  • 43063-349-30: 30 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (43063‑349‑30)
  • 43063-349-60: 60 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (43063‑349‑60)

Active Ingredients:

  • Hydrocodone Bitartrate
  • Ibuprofen

Dosage Strength:

  • 7.5 mg
  • 200 mg

Inactive Ingredients:

  • Colloidal Silicon Dioxide
  • Croscarmellose Sodium
  • Hypromellose 2910 (3 Mpa.s)
  • Hypromellose 2910 (6 Mpa.s)
  • Lactose Monohydrate
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Polyethylene Glycol 400
  • Polyethylene Glycol 8000
  • Polydextrose
  • Starch, Pregelatinized Corn
  • Titanium Dioxide
  • Triacetin

Pharmaceutical Classes:

  • Opioid Agonist [EPC]
  • Opioid Agonists [MoA]
  • Cyclooxygenase Inhibitors [MoA]
  • Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
  • Nonsteroidal Anti-inflammatory Drug [EPC]

Related Products:

Based on records with the same trade name.
  • 55289-944 Hydrocodone Bitartrate 7.5 mg / Ibuprofen 200 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 0093-5161 Hydrocodone Bitartrate 7.5 mg / Ibuprofen 200 mg Oral Tablet by Teva Pharmaceuticals USA Inc
  • 0603-3584 Hydrocodone Bitartrate and Ibuprofen Oral Tablet, Film Coated by Qualitest Pharmaceuticals
  • 0603-3586 Hydrocodone Bitartrate and Ibuprofen Oral Tablet, Film Coated by Qualitest Pharmaceuticals
  • 0603-3897 Hydrocodone Bitartrate 7.5 mg / Ibuprofen 200 mg Oral Tablet by Qualitest Pharmaceuticals
  • 13107-004 Hydrocodone Bitartrate and Ibuprofen Oral Tablet, Film Coated by Aurolife Pharma, LLC
  • 16590-296 Hydrocodone Bitartrate 7.5 mg / Ibuprofen 200 mg Oral Tablet by Stat Rx USA LLC
  • 33261-378 Hydrocodone Bitartrate 7.5 mg / Ibuprofen 200 mg Oral Tablet by Aidarex Pharmaceuticals LLC
  • 35356-586 Hydrocodone Bitartrate 5 mg / Ibuprofen 200 mg Oral Tablet by Lake Erie Medical Dba Quality Care Products LLC Care Producst
  • 35356-804 Hydrocodone Bitartrate 7.5 mg / Ibuprofen 200 mg Oral Tablet by Lake Erie Medical Dba Quality Care Products LLC Care Producst
  • 42549-656 Hydrocodone Bitartrate 7.5 mg / Ibuprofen 200 mg Oral Tablet by Stat Rx USA LLC
  • 49999-588 Hydrocodone Bitartrate 7.5 mg / Ibuprofen 200 mg Oral Tablet by Lake Erie Medical Dba Quality Care Products LLC
  • 52959-738 Hydrocodone Bitartrate 7.5 mg / Ibuprofen 200 mg Oral Tablet by H.j. Harkins Company, Inc.
  • 53746-116 Hydrocodone Bitartrate 2.5 mg / Ibuprofen 200 mg Oral Tablet by Amneal Pharmaceuticals, LLC
  • 53746-117 Hydrocodone Bitartrate 10 mg / Ibuprofen 200 mg Oral Tablet by Amneal Pharmaceuticals, LLC
  • 53746-145 Hydrocodone Bitartrate 7.5 mg / Ibuprofen 200 mg Oral Tablet by Amneal Pharmaceuticals, LLC
  • 53746-146 Hydrocodone Bitartrate 5 mg / Ibuprofen 200 mg Oral Tablet by Amneal Pharmaceuticals, LLC
  • 54569-6121 Hydrocodone Bitartrate 7.5 mg / Ibuprofen 200 mg Oral Tablet by A-s Medication Solutions LLC
  • 54868-4976 Hydrocodone Bitartrate 7.5 mg / Ibuprofen 200 mg Oral Tablet by Physicians Total Care, Inc.
  • 55700-639 Hydrocodone Bitartrate and Ibuprofen Oral Tablet, Film Coated by Lake Erie Medical Dba Quality Care Products LLC
  • More related products ...

NDC QR Code

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