TRAMADOL HYDROCHLORIDE

Product NDC
55700-996
11-digit product format
557000996
Labeler code
55700
Product ID
55700-996_77c7c0be-a1bf-4912-b895-77bdcfe7c67f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA200503
Marketing category
ANDA
Marketing start
2023-01-24
Marketing end
2027-01-31
Substance
TRAMADOL HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CIV
NDC exclude flag
No
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
9N7R477WCKTRAMADOL HYDROCHLORIDE36282-47-0TRAMADOL HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-996-305570009963030 TABLET, EXTENDED RELEASE in 1 BOTTLE (55700-996-30) 2023-01-242027-01-31NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
TRAMADOL HYDROCHLORIDEQuality Care Products, LLC2024-12-19HUMAN PRESCRIPTION DRUG LABEL2