TRAMADOL HYDROCHLORIDE

Product NDC
68788-7762
11-digit product format
687887762
Labeler code
68788
Product ID
68788-7762_820477b9-3601-4aeb-b262-b30c01129c88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA201384
Marketing category
ANDA
Marketing start
2020-07-22
Marketing end
0000-00-00
Substance
TRAMADOL HYDROCHLORIDE
Active strength
200 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
68788-7762-2EA - Each68788-7762c3c807aa-adfa-4761-b9e7-80e81f3fc6c112020-09-14
68788-7762-3EA - Each68788-7762dcb75afa-3eb1-46a9-9a68-c298e73e288912020-09-14
68788-7762-6EA - Each68788-776232d2ca78-9fc1-45c8-a646-a9adca6eaf6412020-09-14
68788-7762-9EA - Each68788-7762611496a1-8172-4ae0-997f-b9b593ef9f6612020-09-14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7762-26878877620220 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7762-2) 2020-07-220000-00-00NoNoCurrent
68788-7762-36878877620330 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7762-3) 2020-07-220000-00-00NoNoCurrent
68788-7762-66878877620660 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7762-6) 2020-07-220000-00-00NoNoCurrent
68788-7762-96878877620990 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7762-9) 2020-07-220000-00-00NoNoCurrent