NDC 0245-1645

Pacerone

Amiodarone Hydrochloride

Pacerone is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Upsher-smith Laboratories, Llc. The primary component is Amiodarone Hydrochloride.

Product ID0245-1645_f949425f-2c71-4663-b230-8d2992aecd8b
NDC0245-1645
Product TypeHuman Prescription Drug
Proprietary NamePacerone
Generic NameAmiodarone Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2020-07-02
Marketing CategoryANDA / ANDA
Application NumberANDA075135
Labeler NameUpsher-Smith Laboratories, LLC
Substance NameAMIODARONE HYDROCHLORIDE
Active Ingredient Strength400 mg/1
Pharm ClassesCytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0245-1645-01

100 BLISTER PACK in 1 CARTON (0245-1645-01) > 1 TABLET in 1 BLISTER PACK (0245-1645-89)
Marketing Start Date2020-10-01
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Pacerone" or generic name "Amiodarone Hydrochloride"

NDCBrand NameGeneric Name
0245-0144PaceroneAmiodarone Hydrochloride
0245-0145PaceroneAmiodarone Hydrochloride
0245-0147PaceroneAmiodarone Hydrochloride
0245-1645PaceroneAmiodarone Hydrochloride
55154-5606PaceronePacerone
65084-456PaceronePacerone
67544-570PaceronePacerone
42494-307Amiodarone HClAmiodarone Hydrochloride
0143-9875Amiodarone HydrochlorideAmiodarone Hydrochloride
0185-0144Amiodarone HydrochlorideAmiodarone Hydrochloride
0404-9815Amiodarone HydrochlorideAmiodarone Hydrochloride
0615-4545Amiodarone HydrochlorideAmiodarone Hydrochloride
0615-8213Amiodarone hydrochlorideAmiodarone hydrochloride
0615-8258Amiodarone HydrochlorideAmiodarone Hydrochloride
0904-6556Amiodarone hydrochlorideAmiodarone hydrochloride
0904-6993Amiodarone HydrochlorideAmiodarone Hydrochloride
16714-843Amiodarone HydrochlorideAmiodarone Hydrochloride
16714-844Amiodarone HydrochlorideAmiodarone Hydrochloride
16714-845Amiodarone HydrochlorideAmiodarone Hydrochloride
21695-796Amiodarone hydrochlorideAmiodarone hydrochloride
25021-302amiodarone hydrochlorideamiodarone hydrochloride
29300-359Amiodarone HydrochlorideAmiodarone Hydrochloride
42291-118Amiodarone HydrochlorideAmiodarone Hydrochloride
42291-139Amiodarone HydrochlorideAmiodarone Hydrochloride

Trademark Results [Pacerone]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PACERONE
PACERONE
75028678 2127660 Live/Registered
UPSHER-SMITH LABORATORIES, LLC
1995-12-06
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.