FDA.reportPublic FDA data

Tramadol Hydrochloride and Acetaminophen

Product NDC
63629-3406
11-digit product format
636293406
Labeler code
63629
Product ID
63629-3406_34f0bb89-bf50-451d-bca5-aa07a44e751a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090485
Marketing category
ANDA
Marketing start
2009-12-17
Marketing end
0000-00-00
Substance
TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN
Active strength
38 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-3406-1EA - Each63629-3406e7ea077d-c640-4d8a-b263-82277f3f702112012-07-24
63629-3406-2EA - Each63629-3406f18b140d-8c5a-4d5e-a5a3-bceaf2e76e8112012-07-24
63629-3406-3EA - Each63629-3406c5057c4c-12f9-4271-ab80-7196e8ba53f812012-07-24
63629-3406-4EA - Each63629-34061c608f0f-c175-4a1f-8f63-3defb8805dab12012-07-24
63629-3406-5EA - Each63629-3406884c8520-6a61-4415-95bc-7fa5c45b954812012-07-24
63629-3406-6EA - Each63629-3406bcc086b8-73df-416b-90c1-fc981eb29cea12012-07-24
63629-3406-7EA - Each63629-34067c51ca92-d8e6-4221-a083-7f59168f170912012-07-24
63629-3406-8EA - Each63629-34061d4fbd74-3a5f-4d3f-adef-c02da6eee1c212013-02-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-3406-06362934060028 TABLET in 1 BOTTLE (63629-3406-0) 28 tablet2009-12-170000-00-00NoNoCurrent
63629-3406-16362934060120 TABLET in 1 BOTTLE (63629-3406-1) 20 tablet2009-12-170000-00-00NoNoCurrent
63629-3406-26362934060260 TABLET in 1 BOTTLE (63629-3406-2) 60 tablet2009-12-170000-00-00NoNoCurrent
63629-3406-36362934060350 TABLET in 1 BOTTLE (63629-3406-3) 50 tablet2009-12-170000-00-00NoNoCurrent
63629-3406-46362934060430 TABLET in 1 BOTTLE (63629-3406-4) 30 tablet2009-12-170000-00-00NoNoCurrent
63629-3406-56362934060540 TABLET in 1 BOTTLE (63629-3406-5) 40 tablet2009-12-170000-00-00NoNoCurrent
63629-3406-66362934060690 TABLET in 1 BOTTLE (63629-3406-6) 90 tablet2009-12-170000-00-00NoNoCurrent
63629-3406-763629340607120 TABLET in 1 BOTTLE (63629-3406-7) 120 tablet2009-12-170000-00-00NoNoCurrent
63629-3406-863629340608100 TABLET in 1 BOTTLE (63629-3406-8) 100 tablet2009-12-170000-00-00NoNoCurrent
63629-3406-96362934060945 TABLET in 1 BOTTLE (63629-3406-9) 45 tablet2009-12-170000-00-00NoNoCurrent