FDA.reportPublic FDA data

tramadol hydrochloride

Product NDC
68788-7321
11-digit product format
687887321
Labeler code
68788
Product ID
68788-7321_6e22574e-0e0c-4c11-ba6e-a3df8f1072a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tramadol hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA075964
Marketing category
ANDA
Marketing start
2019-03-12
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
68788-7321-1EA - Each68788-732109534355-ea0a-4eec-bbcd-11db4474e26512019-04-11
68788-7321-2EA - Each68788-73215ab24f2f-7465-445b-83b0-c0ec711f94df12019-04-11
68788-7321-3EA - Each68788-7321632db8a0-703f-451f-9f22-bd2cb5daccef12019-04-11
68788-7321-4EA - Each68788-732102ca3b1e-3cfb-48b5-9231-f202a12fba8e12019-04-11
68788-7321-5EA - Each68788-732189efee66-82bd-48ec-ba3e-209264b18d1412019-04-11
68788-7321-6EA - Each68788-732160f49ab5-d140-482b-8b3f-c048242dfe5212019-04-11
68788-7321-7EA - Each68788-7321765b3014-167f-4b42-9686-35482b72c64a12019-04-11
68788-7321-8EA - Each68788-732101ab5ccf-62ff-414d-b81a-4f708855a09812019-04-11
68788-7321-9EA - Each68788-732197051b15-e0ca-4f5c-824e-4393fe7c2efc12019-04-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7321-168788732101100 TABLET in 1 BOTTLE (68788-7321-1) 100 tablet2019-03-120000-00-00NoNoCurrent
68788-7321-26878873210220 TABLET in 1 BOTTLE (68788-7321-2) 20 tablet2019-03-120000-00-00NoNoCurrent
68788-7321-36878873210330 TABLET in 1 BOTTLE (68788-7321-3) 30 tablet2019-03-120000-00-00NoNoCurrent
68788-7321-46878873210440 TABLET in 1 BOTTLE (68788-7321-4) 40 tablet2019-03-120000-00-00NoNoCurrent
68788-7321-56878873210515 TABLET in 1 BOTTLE (68788-7321-5) 15 tablet2019-03-120000-00-00NoNoCurrent
68788-7321-66878873210660 TABLET in 1 BOTTLE (68788-7321-6) 60 tablet2019-03-120000-00-00NoNoCurrent
68788-7321-76878873210750 TABLET in 1 BOTTLE (68788-7321-7) 50 tablet2019-03-120000-00-00NoNoCurrent
68788-7321-868788732108120 TABLET in 1 BOTTLE (68788-7321-8) 120 tablet2019-03-120000-00-00NoNoCurrent
68788-7321-96878873210990 TABLET in 1 BOTTLE (68788-7321-9) 90 tablet2019-03-120000-00-00NoNoCurrent