Tramadol Hydrochloride

Product NDC
63187-615
11-digit product format
631870615
Labeler code
63187
Product ID
63187-615_e42cf782-73d9-4cb9-9d74-9ca0535fc2ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
NDA022370
Marketing category
NDA
Marketing start
2015-07-01
Marketing end
0000-00-00
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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-615-30EA - Each63187-615c6bfbff3-5a49-451b-939b-0d975119e28c12016-12-07
63187-615-60EA - Each63187-615a3b88326-ea10-4055-b537-37756ec0e5b412016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-615TRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]4Legacy NDC20200219_33e082f6-6df8-4da5-a47e-8e7f5af168d5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-615-156318706151515 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63187-615-15) 2018-12-010000-00-00NoNoCurrent
63187-615-206318706152020 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63187-615-20) 2018-12-010000-00-00NoNoCurrent
63187-615-306318706153030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63187-615-30) 2018-12-010000-00-00NoNoCurrent
63187-615-606318706156060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63187-615-60) 2018-12-010000-00-00NoNoCurrent
63187-615-7263187061572120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63187-615-72) 2018-12-010000-00-00NoNoCurrent
63187-615-7863187061578180 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63187-615-78) 2018-12-010000-00-00NoNoCurrent
63187-615-906318706159090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63187-615-90) 2018-12-010000-00-00NoNoCurrent