Oxycodone Hydrochloride Capsule
Application # 200534 5 mg 100-count bottle RLD Y

Oxycodone 5 mg Capsule NDC 64950-901-10 Safety Data Sheet Approved Labeling

Oxycodone Hydrochloride Oral Solution
Application # 200535 100 mg/5 mL 30 mL bottle RLD Y

Oxycodone 100mg/5ml Oral Solution NDC 64950-353-03 Safety Data Sheet Approved Labeling

Oxycodone Hydrochloride Oral Solution, USP
Application # 200535 5 mg/5 mL 500 mL bottle, 5 mL Unit Dose Cup, sold in package of 50 RLD N

Oxycodone 5mg/5mL Oral Solution NDC 64950-354-50 Safety Data Sheet Approved Labeling

Potassium Chloride Oral Solution, USP
Application # 206814 20 mEq/15 mL 473 mL bottle RLD Y

Potassium Chloride 20 mEq Oral Solution NDC 64950-320-47 Safety Data Sheet Approved Labeling

Product Update:

New and improved formulation of Potassium Chloride Oral Solution, USP, 20 mEq/15 ml and 40 mEq/15 ml was approved by FDA in May 2019 and shipments began in July 2019. Due to changes in inactive ingredients a new formulation may appear lighter in color and lighter on taste. However, the new formulation meets the same specifications and has the same purity, potency, and safety standards as the old formulation.

The first lot of Potassium Chloride Oral Solution USP, 40 mEq/15 mL is Lot number 32401419A. The first lot of Potassium Chloride Oral Solution USP, 20 mEq/15 mL is lot number 32301719A. Later lots of the same product can be identified by examining the lot numbers, which begin with the same four digits, and the last two digits represent the year (19 being 2019, 20 being 2020). Thus, any lot code ending in 20, and any lot code ending in 19 that is higher than 32401419A or 32301719A were or will be manufactured with the new formulation.

PCS-31-083 rev. 3/2020

Potassium Chloride Oral Solution, USP
Application # 206814 40 mEq/15 mL 473 mL bottle RLD Y

Potassium Chloride 40 mEq Oral Solution NDC 64950-322-47 Safety Data Sheet Approved Labeling

Product Update:

New and improved formulation of Potassium Chloride Oral Solution, USP, 20 mEq/15 ml and 40 mEq/15 ml was approved by FDA in May 2019 and shipments began in July 2019. Due to changes in inactive ingredients a new formulation may appear lighter in color and lighter on taste. However, the new formulation meets the same specifications and has the same purity, potency, and safety standards as the old formulation.

The first lot of Potassium Chloride Oral Solution USP, 40 mEq/15 mL is Lot number 32401419A. The first lot of Potassium Chloride Oral Solution USP, 20 mEq/15 mL is lot number 32301719A. Later lots of the same product can be identified by examining the lot numbers, which begin with the same four digits, and the last two digits represent the year (19 being 2019, 20 being 2020). Thus, any lot code ending in 20, and any lot code ending in 19 that is higher than 32401419A or 32301719A were or will be manufactured with the new formulation.

PCS-31-083 rev. 3/2020

Potassium Chloride for Oral Solution, USP
Application # 208019 20 mEq Unit Dose Pouch, for 20 mEq, sold in cases of 30 and 100 RLD Y

Potassium Chloride for Oral Solution (Powder) NDC 64950-321-30 Safety Data Sheet Approved Labeling

Cocaine Hydrochloride Nasal Solution, USP
Application # 209963 40 mg/mL 4 mL bottle RLD Y

Cocaine Hydrochloride Nasal Solution NDC 64950-362-04 Safety Data Sheet Approved Labeling

Tivorbex (Indomethacin) Capsule (20mg)
Application # N204768 20 mg 30-count bottle RLD Y

Tivorbex Capsule NDC Safety Data Sheet Approved Labeling

Tivorbex (Indomethacin) Capsule (40mg)
Application # N204768 40 mg 30-count bottle RLD Y

Tivorbex Capsule NDC Safety Data Sheet Approved Labeling

Yosprala (aspirin and omeprazole) delayed-release tablet (81mg/40mg)
Application # 205103 81 mg/40 mg sold in 30-count and 90-count bottles RLD Y

Yosprala delayed-release tablets NDC 64950-424-30 and 64950-424-90
See www.yospralahcp.com for more information
Safety Data Sheet Approved Labeling

Yosprala (aspirin and omeprazole) delayed-release tablet (325mg/40mg)
Application # 205103 325 mg/40 mg sold in 30-count and 90-count bottles RLD Y

Yosprala delayed-release tablets NDC 64950-425-30 and 64950-425-90
See www.yospralahcp.com for more information
Safety Data Sheet Approved Labeling

Hycodan (Hydrocodone Bitartate and Homatropine Methylbromide) oral solution
Application # 005213 5 mg Hydrocodone Bitartrate, USP and 1.5 mg Homatropine Methylbromide, USP per 5 mL 473 mL bottle RLD Y

Hydrocodone Bitartate and Acetaminophen oral solution
Application # 040894 7.5 mg Hydrocodone Bitartrate, USP and 325 mg Acetaminophen, USP per 15 mL 473 mL bottle RLD N