Tramadol Hydrochloride

Product NDC
33261-960
11-digit product format
332610960
Labeler code
33261
Product ID
33261-960_d21288f6-b27e-4d24-93ba-2422b08036ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
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
2019-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-960-30Tramadol Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301
33261-960-60Tramadol Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-960-30EA - Each33261-9605514c9f3-75ff-447a-99d2-91a1ce722d5712017-03-06
33261-960-60EA - Each33261-9607790c416-e92a-44c4-b8ad-660139a327c412017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-960TRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 2 package rows20170302_fba82d4a-f015-4f1f-bca8-049096154c09.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248115traMADol HCl 150 MG 24HR Extended Release Oral CapsulePSNfba82d4a-f015-4f1f-bca8-049096154c091
124811524 HR tramadol hydrochloride 150 MG Extended Release Oral CapsuleSCDfba82d4a-f015-4f1f-bca8-049096154c091
1248115tramadol HCl 150 MG 24 HR Extended Release Oral CapsuleSYfba82d4a-f015-4f1f-bca8-049096154c091

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-960-303326109603030 in 1 BOTTLEHistorical
33261-960-603326109606060 in 1 BOTTLEHistorical