Tramadol Hydrochloride

Product NDC
69420-5150
11-digit product format
694205150
Labeler code
69420
Product ID
69420-5150_ce2144f7-f182-4419-a3d8-a0b3818d2ab9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
SA3, LLC
Application
NDA022370
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2015-07-01
Marketing end
2020-08-31
Substance
TRAMADOL HYDROCHLORIDE
Active strength
150 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69420-5150-12020-08-24C16284748780-19d75b9cf-dfe8-f424-e053-dadaa90a57ce85d2e4b3-e1e9-4a69-9092-b3d3731d4b23
69420-5150-12020-01-31C16284748780-19d75b9cf-dfe8-f424-e053-dadaa90a57ce85d2e4b3-e1e9-4a69-9092-b3d3731d4b23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69420-5150-1EA - Each69420-51506bf99cff-4caf-4f5e-970a-e3cd62814ee212018-11-06