tramadol hydrochloride

Product NDC
70518-0258
11-digit product format
705180258
Labeler code
70518
Product ID
70518-0258_eb50c305-0d05-c712-e053-2a95a90a7382
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tramadol hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA075964
Marketing category
ANDA
Marketing start
2017-02-23
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
70518-0258-2EA - Each70518-0258315022a7-efe9-47d4-bf11-f6faed79f95512022-12-07
70518-0258-3EA - Each70518-02580ba97e32-0404-4fca-8e6a-8db7b63dd0ad12024-05-16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-0258-07051802580030 TABLET in 1 BLISTER PACK (70518-0258-0) 30 tablet2017-02-230000-00-00NoNoCurrent
70518-0258-170518025801120 TABLET in 1 BOTTLE, PLASTIC (70518-0258-1) 120 tablet2018-09-060000-00-00NoNoCurrent
70518-0258-27051802580290 TABLET in 1 BOTTLE, PLASTIC (70518-0258-2) 90 tablet2018-11-020000-00-00NoNoCurrent
70518-0258-37051802580330 TABLET in 1 BOTTLE, PLASTIC (70518-0258-3) 30 tablet2019-02-040000-00-00NoNoCurrent
70518-0258-470518025804180 TABLET in 1 BOTTLE, PLASTIC (70518-0258-4) 180 tablet2020-03-090000-00-00NoNoCurrent