61919-494 : Hydrocodone Bitartrate Oral Tablet

NDC:	61919-494
Labeler:	Direct Rx
Product Type:	Human Prescription Drug
Drug Name:	Hydrocodone Bitartrate
Dosage Form:	Oral Tablet
Application #:	ANDA040736
Rev. Date:	Jul 23, 2019
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:	IP;109
Shapes:	Capsule
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:

• 61919-494-08: 8 TABLET IN 1 BOTTLE (61919‑494‑08)
• 61919-494-20: 20 TABLET IN 1 BOTTLE (61919‑494‑20)
• 61919-494-30: 30 TABLET IN 1 BOTTLE (61919‑494‑30)
• 61919-494-60: 60 TABLET IN 1 BOTTLE (61919‑494‑60)
• 61919-494-72: 120 BOTTLE IN 1 BOTTLE (61919‑494‑72) > 90 BOTTLE IN 1 BOTTLE (61919‑494‑90) > 60 BOTTLE IN 1 BOTTLE (61919‑494‑60) > 30 TABLET IN 1 BOTTLE (61919‑494‑30)
• 61919-494-90: 90 TABLET IN 1 BOTTLE (61919‑494‑90)

Active Ingredients:

• Hydrocodone Bitartrate
• Acetaminophen

Inactive Ingredients:

• Crospovidone, Unspecified
• Starch, Corn
• Povidone
• Stearic Acid /

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 61919-118 Hydrocodone Bitartrate Oral Tablet by Direct Rx
• 61919-296 Hydrocodone Bitartrate Oral Tablet, Coated by Direct Rx
• 47781-392 Hydrocodone Bitartrate 20 mg Oral Tablet, Extended Release by Alvogen Inc.
• 47781-393 Hydrocodone Bitartrate 30 mg Oral Tablet, Extended Release by Alvogen Inc.
• 47781-394 Hydrocodone Bitartrate 40 mg Oral Tablet, Extended Release by Alvogen Inc.
• 47781-395 Hydrocodone Bitartrate 60 mg Oral Tablet, Extended Release by Alvogen Inc.
• 47781-396 Hydrocodone Bitartrate 80 mg Oral Tablet, Extended Release by Alvogen Inc.
• 47781-397 Hydrocodone Bitartrate 100 mg Oral Tablet, Extended Release by Alvogen Inc.
• 47781-398 Hydrocodone Bitartrate 120 mg Oral Tablet, Extended Release by Alvogen Inc.
• 47781-409 Hydrocodone Bitartrate 10 mg Oral Capsule, Extended Release by Alvogen Inc.
• 47781-410 Hydrocodone Bitartrate 15 mg Oral Capsule, Extended Release by Alvogen Inc.
• 47781-411 Hydrocodone Bitartrate 20 mg Oral Capsule, Extended Release by Alvogen Inc.
• 47781-412 Hydrocodone Bitartrate 30 mg Oral Capsule, Extended Release by Alvogen Inc.
• 47781-413 Hydrocodone Bitartrate 40 mg Oral Capsule, Extended Release by Alvogen Inc.
• 47781-414 Hydrocodone Bitartrate 50 mg Oral Capsule, Extended Release by Alvogen Inc.
• 65224-910 Hydrocodone Bitartrate 10 mg Oral Capsule, Extended Release by Persion Pharmaceuticals LLC
• 65224-915 Hydrocodone Bitartrate 15 mg Oral Capsule, Extended Release by Persion Pharmaceuticals LLC
• 65224-920 Hydrocodone Bitartrate 20 mg Oral Capsule, Extended Release by Persion Pharmaceuticals LLC
• 65224-930 Hydrocodone Bitartrate 30 mg Oral Capsule, Extended Release by Persion Pharmaceuticals LLC
• 65224-940 Hydrocodone Bitartrate 40 mg Oral Capsule, Extended Release by Persion Pharmaceuticals LLC
• More related products ...

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