Hydrocodone Bitartrate and Ibuprofen

Product NDC
68084-841
11-digit product format
680840841
Labeler code
68084
Product ID
68084-841_ec1a8451-4cc9-5e13-e053-2a95a90a3376
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA076642
Marketing category
ANDA
Marketing start
2014-09-24
Marketing end
0000-00-00
Substance
HYDROCODONE BITARTRATE; IBUPROFEN
Active strength
8 mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-841-01EA - Each68084-841bb1b46b2-2feb-4ee8-8881-cff450a4064112015-03-03
68084-841-09EA - Each68084-8410d3c3338-c295-4477-9863-e7c0e9c0056912014-11-05
68084-841-11EA - Each68084-8414e3c646a-b599-4ebe-8cb4-2cb4e5cbbec212014-11-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-841-0168084084101100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-841-01) > 1 TABLET in 1 BLISTER PACK (68084-841-11) 100 blister pack2015-02-130000-00-00NoNoCurrent