12634-783 : Apap 500 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet

NDC:	12634-783
Labeler:	Apotheca Inc.
Product Type:	Human Prescription Drug
Drug Name:	Hydrocodone Bitartrate and Acetaminophen
Dosage Form:	Oral Tablet
Application #:	ANDA081080
Rev. Date:	May 2, 2006
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;385
Shapes:	Capsule
Colors:	White
Size (mm):	18
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:

• 12634-783-00: 10 TABLET IN 1 BOTTLE (12634‑783‑00)
• 12634-783-01: 100 TABLET IN 1 BOTTLE (12634‑783‑01)
• 12634-783-50: 50 TABLET IN 1 BOTTLE (12634‑783‑50)
• 12634-783-55: 15 TABLET IN 1 BLISTER PACK (12634‑783‑55)
• 12634-783-71: 30 TABLET IN 1 BOTTLE (12634‑783‑71)
• 12634-783-80: 20 TABLET IN 1 BOTTLE (12634‑783‑80)
• 12634-783-85: 15 TABLET IN 1 BOTTLE (12634‑783‑85)
• 12634-783-91: 1 TABLET IN 1 BLISTER PACK (12634‑783‑91)
• 12634-783-96: 6 TABLET IN 1 BOTTLE (12634‑783‑96)

Active Ingredients:

• Acetaminophen
• Hydrocodone Bitartrate

Inactive Ingredients:

• Croscarmellose Sodium
• Crospovidone
• Magnesium Stearate
• Cellulose, Microcrystalline
• Povidone
• Stearic Acid

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 12634-166 Apap 650 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Apotheca Inc.
• 12634-514 Apap 500 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Apotheca Inc.
• 12634-849 Apap 750 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Apotheca Inc.
• 12634-144 Apap 325 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Apotheca, Inc.
• 12634-256 Apap 650 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Apotheca, Inc.
• 12634-260 Hydrocodone Bitartrate and Acetaminophen Oral Tablet by Apotheca, Inc.
• 12634-615 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Apotheca, Inc
• 12634-616 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Apotheca, Inc
• 12634-978 Apap 500 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Apotheca, Inc.
• 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.
• 0121-2316 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Pharmaceutical Associates, Inc.
• 0121-4655 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Pharmaceutical Associates, Inc.
• 0121-4771 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Pharmaceutical Associates, Inc.
• 0121-4772 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Pharmaceutical Associates, Inc.
• 0179-0112 Apap 325 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Kaiser Foundation Hospitals
• 0179-0113 Apap 325 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Kaiser Foundation Hospitals
• 0179-0116 Apap 325 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Kaiser Foundation Hospitals
• 0179-1026 Apap 500 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Kaiser Foundation Hospitals
• More related products ...

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