0591-0503 : Apap 650 mg / Hydrocodone Bitartrate 10 mg Oral Tablet

NDC:	0591-0503
Labeler:	Watson Laboratories, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Hydrocodone Bitartrate and Acetaminophen
Dosage Form:	Oral Tablet
Application #:	ANDA040094
Rev. Date:	Sep 29, 1995
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;503
Shapes:	Oval
Colors:	Green
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.

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:

• 0591-0503-01: 100 TABLET IN 1 BOTTLE, PLASTIC (0591‑0503‑01)
• 0591-0503-05: 500 TABLET IN 1 BOTTLE, PLASTIC (0591‑0503‑05)

Active Ingredients:

• Acetaminophen
• Hydrocodone Bitartrate

Inactive Ingredients:

• Anhydrous Lactose
• Croscarmellose Sodium
• Crospovidone
• Magnesium Stearate
• Cellulose, Microcrystalline
• Povidones
• Starch, Corn
• Stearic Acid
• Fd&c Blue No. 1
• D&c Yellow No. 10
• Aluminum Oxide

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 0591-0349 Apap 500 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Watson Laboratories, Inc.
• 0591-0385 Apap 500 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Watson Laboratories, Inc.
• 0591-0387 Apap 750 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Watson Laboratories, Inc.
• 0591-0388 Apap 500 mg / Hydrocodone Bitartrate 2.5 mg Oral Tablet by Watson Laboratories, Inc.
• 0591-0502 Apap 650 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Watson Laboratories, Inc.
• 0591-0517 Apap 660 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Watson Laboratories, Inc.
• 0591-0540 Apap 500 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Watson Laboratories, Inc.
• 0591-0853 Apap 325 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Watson Laboratories, Inc.
• 0591-2605 Apap 325 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Watson Laboratories, Inc.
• 0591-2607 Apap 750 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Watson Laboratories, Inc.
• 0591-2609 Apap 500 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Watson Laboratories, Inc.
• 0591-2610 Apap 650 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Watson Laboratories, Inc.
• 0591-2611 Apap 650 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Watson Laboratories, Inc.
• 0591-2612 Apap 325 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Watson Laboratories, Inc.
• 0591-3203 Apap 325 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Watson Laboratories, Inc.
• 0591-3228 Apap 750 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Watson Laboratories, Inc.
• 0591-2172 Hydrocodone Bitartrate and Acetaminophen Oral Tablet by Actavis Pharma, Inc.
• 0591-2174 Hydrocodone Bitartrate and Acetaminophen Oral Tablet by Actavis Pharma, Inc.
• 0591-2175 Hydrocodone Bitartrate and Acetaminophen Oral Tablet by Actavis Pharma, Inc.
• 0591-2176 Hydrocodone Bitartrate and Acetaminophen Oral Tablet by Actavis Pharma, Inc.
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