16590-114 : Apap 325 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet

NDC:	16590-114
Labeler:	Stat Rx USA LLC
Product Type:	Human Prescription Drug
Drug Name:	Hydrocodone Bitartrate and Acetaminophen
Dosage Form:	Oral Tablet
Application #:	ANDA040148
Rev. Date:	Sep 12, 2000
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;3203
Shapes:	Oval
Colors:	Orange
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.

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:

• 16590-114-15: 15 TABLET IN 1 BOTTLE (16590‑114‑15)
• 16590-114-20: 20 TABLET IN 1 BOTTLE (16590‑114‑20)
• 16590-114-28: 28 TABLET IN 1 BOTTLE (16590‑114‑28)
• 16590-114-30: 30 TABLET IN 1 BOTTLE (16590‑114‑30)
• 16590-114-40: 40 TABLET IN 1 BOTTLE (16590‑114‑40)
• 16590-114-45: 45 TABLET IN 1 BOTTLE (16590‑114‑45)
• 16590-114-60: 60 TABLET IN 1 BOTTLE (16590‑114‑60)
• 16590-114-71: 100 TABLET IN 1 BOTTLE (16590‑114‑71)
• 16590-114-72: 120 TABLET IN 1 BOTTLE (16590‑114‑72)
• 16590-114-82: 180 TABLET IN 1 BOTTLE (16590‑114‑82)
• 16590-114-90: 90 TABLET IN 1 BOTTLE (16590‑114‑90)

Active Ingredients:

• Acetaminophen
• Hydrocodone Bitartrate

Inactive Ingredients:

• Croscarmellose Sodium
• Crospovidone
• Magnesium Stearate
• Cellulose, Microcrystalline
• Povidone
• Starch, Pregelatinized Corn
• Stearic Acid
• Fd&c Yellow No. 6
• Aluminum Oxide

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 16590-112 Apap 500 mg / Hydrocodone Bitartrate 2.5 mg Oral Tablet by Stat Rx USA LLC
• 16590-113 Apap 500 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Stat Rx USA LLC
• 16590-115 Apap 500 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Stat Rx USA LLC
• 16590-116 Apap 650 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Stat Rx USA LLC
• 16590-117 Apap 750 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Stat Rx USA LLC
• 16590-118 Apap 325 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Stat Rx USA LLC
• 16590-119 Apap 500 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Stat Rx USA LLC
• 16590-120 Apap 650 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Stat Rx USA LLC
• 16590-494 Apap 325 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Stat Rx USA LLC
• 16590-875 Apap 660 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Stat Rx USA LLC
• 42549-514 Apap 325 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Stat Rx USA LLC
• 42549-516 Apap 500 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Stat Rx USA LLC
• 42549-556 Apap 325 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Stat Rx USA LLC
• 42549-557 Apap 325 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Stat Rx USA LLC
• 42549-586 Apap 750 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Stat Rx USA LLC
• 42549-609 Apap 500 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Stat Rx USA LLC
• 42549-653 Apap 500 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Stat Rx USA LLC
• 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.
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