61919-208 : Direct Rx Oral Tablet


NDC61919-208
Labeler: Direct Rx
Product Type: Human Prescription Drug
Drug Name: Direct Rx
Dosage Form: Oral Tablet
Application #: ANDA201013
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: U02
Shapes:  Capsule
Colors:  White
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.

NDC Package Codes:

  • 61919-208-26: 26 TABLET IN 1 BOTTLE (61919‑208‑26)
  • 61919-208-30: 30 TABLET IN 1 BOTTLE (61919‑208‑30)
  • 61919-208-60: 60 TABLET IN 1 BOTTLE (61919‑208‑60)
  • 61919-208-72: 120 TABLET IN 1 BOTTLE (61919‑208‑72)
  • 61919-208-90: 90 TABLET IN 1 BOTTLE (61919‑208‑90)

Active Ingredients:

  • Hydrocodone Bitartrate
  • Acetaminophen

Dosage Strength:

  • 7.5 mg
  • 325 mg

Inactive Ingredients:

  • Croscarmellose Sodium
  • Crospovidone (15 Mpa.s At 5%)
  • Magnesium Stearate
  • Starch, Corn
  • Stearic Acid
  • Silicon Dioxide
  • Cellulose, Microcrystalline
  • Povidone K30 /
  • Magnesium Stearate
  • Povidone K30
  • Silicon Dioxide
  • Crospovidone (15 Mpa.s At 5%)
  • Stearic Acid
  • Croscarmellose Sodium
  • Cellulose, Microcrystalline
  • Starch, Corn /
  • Silicon Dioxide
  • Cellulose, Microcrystalline
  • Croscarmellose Sodium
  • Crospovidone (15 Mpa.s At 5%)
  • Magnesium Stearate
  • Stearic Acid
  • Povidone K30
  • Starch, Corn /
  • Silicon Dioxide
  • Croscarmellose Sodium
  • Crospovidone
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Povidone K30
  • Starch, Corn
  • Stearic Acid

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 61919-061 Direct Rx Oral Tablet by Direct Rx
  • 61919-066 Direct Rx 500 mg Oral Tablet by Direct Rx
  • 61919-080 Direct Rx Oral Tablet by Direct Rx
  • 61919-269 Direct Rx 1.5 mg Oral Tablet by Direct Rx
  • 61919-283 Direct Rx 200 mg Oral Tablet by Direct Rx
  • 61919-297 Direct Rx .125 mg Oral Tablet by Direct Rx
  • 61919-335 Direct Rx Oral Tablet by Direct Rx
  • 61919-389 Direct Rx 20 mg Oral Tablet by Direct Rx
  • 61919-390 Direct Rx 40 mg Oral Tablet by Direct Rx
  • 61919-474 Direct Rx 100 mg Oral Tablet by Direct Rx
  • 61919-775 Direct Rx 100 mg Oral Capsule by Direct Rx
  • 61919-919 Direct Rx 1 g/1 Oral Capsule by Direct Rx

NDC QR Code

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NDC 61919-208 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.