tramadol hydrochloride

Product NDC
0904-7179
11-digit product format
009047179
Labeler code
0904
Product ID
0904-7179_0742ec44-f8b4-45c5-a36e-2638bdaa2e44
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tramadol hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA075964
Marketing category
ANDA
Marketing start
2002-06-22
Marketing end
0000-00-00
Substance
TRAMADOL HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CIV
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
0904-7179-61EA - Each0904-7179b5c7b439-9e5c-47ee-b2aa-e7b23e6e3dd212022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7179TRAMADOL HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]3Legacy NDC20241102_0742ec44-f8b4-45c5-a36e-2638bdaa2e44.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7179-6100904717961100 BLISTER PACK in 1 CARTON (0904-7179-61) > 1 TABLET in 1 BLISTER PACK100 blister pack2002-06-220000-00-00NoNoCurrent