tramadol hydrochloride

Product NDC
68071-4802
11-digit product format
680714802
Labeler code
68071
Product ID
68071-4802_bb8f4be2-c3f1-3be6-e053-2995a90aac3f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tramadol hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
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
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4802-22024-06-14C16284748780-1f386c64a-4059-0266-e053-dadaa90a7c1a84008e09-8bc2-536b-e053-2a91aa0a2a16
68071-4802-22023-01-30C16284748780-1f386c64a-4059-0266-e053-dadaa90a7c1a84008e09-8bc2-536b-e053-2a91aa0a2a16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4802-26807148020220 TABLET in 1 BOTTLE (68071-4802-2) 20 tablet2019-03-130000-00-00NoNoCurrent