Hydrocodone Bitatrate and Acetaminophen

Product NDC

65084-453

11-digit product format

650840453

Labeler code

65084

Product ID

65084-453_1aee5ab4-6f3d-44f4-952b-0a2aa7915679

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Hydrocodone Bitatrate and Acetaminophen

Dosage form

TABLET

Route

ORAL

Labeler

Mckesson Rxpak Inc

Application

ANDA040148

Marketing category

ANDA

Marketing start

2013-03-12

Marketing end

0000-00-00

Substance

HYDROCODONE BITARTRATE; ACETAMINOPHEN

Active strength

10 mg/1; mg/1

Pharmacologic classes

Opioid Agonist [EPC],Opioid Agonists [MoA]

NDC exclude flag

E

Listing certified through

2018-12-31

Current FDA listing

Historical FDA.report record