TYLENOL with Codeine

Product NDC

50458-515

11-digit product format

504580515

Labeler code

50458

Product ID

50458-515_44171662-6387-11ea-b4d5-18e4fb2ca371

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

acetaminophen and codeine phosphate

Dosage form

TABLET

Route

ORAL

Labeler

Janssen Pharmaceuticals, Inc.

Application

ANDA085055

Marketing category

ANDA

Marketing start

1977-08-17

Marketing end

2021-01-11

Substance

ACETAMINOPHEN; CODEINE PHOSPHATE

Active strength

300 mg/1; mg/1

Pharmacologic classes

Full Opioid Agonists [MoA],Opioid Agonist [EPC]

DEA schedule

CIII

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record