Tramadol Hydrochloride

Product NDC
69677-316
11-digit product format
696770316
Labeler code
69677
Product ID
69677-316_5b3602f4-54f1-9461-e053-2a91aa0a99b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Mas Management Group, Inc.
Application
NDA022370
Marketing category
NDA
Marketing start
2017-07-01
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
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
43d017e1-6ae6-7555-71d1-c249236d6f26Product name420251117
bff1fbab-f4cc-4993-b7de-2b555ee5eb73Product name120220509
c563c906-2606-457c-bb1b-5a623daed55bProduct name120210511
43a9f8f9-34aa-8ae8-719e-5489454f7720Product name520200123
abd2f6f2-3fa7-4571-af8a-d67f89bdcb75Product name120190927
377068df-225f-7318-a910-a1987cdfa361Product name320170608
9457302e-0ca3-d9ff-0863-1b24b6107218Product name120140508
d5c49867-1fe9-7a44-3319-814417011d51Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69677-316-012020-01-31C16284748780-19d75b9d0-427c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Tramadol Hydrochloride Extended- Release Capsules safely and effectively. See full prescribing information for Tramadol Hydrochloride Extended-Release Capsules. Tramadol Hydrochloride Extended-Release Capsules Initial U.S. Approval: 1995
69677-316-302020-01-31C16284748780-19d75b9d0-427c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Tramadol Hydrochloride Extended- Release Capsules safely and effectively. See full prescribing information for Tramadol Hydrochloride Extended-Release Capsules. Tramadol Hydrochloride Extended-Release Capsules Initial U.S. Approval: 1995
69677-316-602020-01-31C16284748780-19d75b9d0-427c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Tramadol Hydrochloride Extended- Release Capsules safely and effectively. See full prescribing information for Tramadol Hydrochloride Extended-Release Capsules. Tramadol Hydrochloride Extended-Release Capsules Initial U.S. Approval: 1995
69677-316-902020-01-31C16284748780-19d75b9d0-427c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Tramadol Hydrochloride Extended- Release Capsules safely and effectively. See full prescribing information for Tramadol Hydrochloride Extended-Release Capsules. Tramadol Hydrochloride Extended-Release Capsules Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69677-316-01Tramadol Hydrochloride120 in 1 BOTTLECAPSULE, EXTENDED RELEASE1201
69677-316-30Tramadol Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301
69677-316-60Tramadol Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE601
69677-316-90Tramadol Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69677-316TRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MAS MANAGEMENT GROUP, INC.]1Legacy NDC, 4 package rows20171108_5b3602f4-54f0-9461-e053-2a91aa0a99b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248115traMADol HCl 150 MG 24HR Extended Release Oral CapsulePSN5b3602f4-54f0-9461-e053-2a91aa0a99b91
124811524 HR tramadol hydrochloride 150 MG Extended Release Oral CapsuleSCD5b3602f4-54f0-9461-e053-2a91aa0a99b91
1248115tramadol HCl 150 MG 24 HR Extended Release Oral CapsuleSY5b3602f4-54f0-9461-e053-2a91aa0a99b91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
69677-316-0169677031601120 in 1 BOTTLEHistorical
69677-316-306967703163030 in 1 BOTTLEHistorical
69677-316-606967703166060 in 1 BOTTLEHistorical
69677-316-906967703169090 in 1 BOTTLEHistorical