FDA.reportPublic FDA data

Tramadol Hydrochloride

Product NDC
63874-532
11-digit product format
638740532
Labeler code
63874
Product ID
63874-532_48b18a1e-404e-4b1e-b539-94d6993c8a76
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Altura Pharmaceuticals, Inc.
Application
ANDA076003
Marketing category
ANDA
Marketing start
2010-01-01
Marketing end
0000-00-00
Substance
TRAMADOL HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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
63874-532-002019-10-21C16284748780-1956f9ecf-c123-621f-e053-dbdaa90a74adTramadol Hydrochloride Tablets
63874-532-012019-10-21C16284748780-1956f9ecf-c123-621f-e053-dbdaa90a74adTramadol Hydrochloride Tablets
63874-532-332019-10-21C16284748780-1956f9ecf-c123-621f-e053-dbdaa90a74adTramadol Hydrochloride Tablets
63874-532-632019-10-21C16284748780-1956f9ecf-c123-621f-e053-dbdaa90a74adTramadol Hydrochloride Tablets
63874-532-932019-10-21C16284748780-1956f9ecf-c123-621f-e053-dbdaa90a74adTramadol Hydrochloride Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63874-532-00Tramadol Hydrochloride120 in 1 BOTTLE, PLASTICTABLET1202
63874-532-01Tramadol Hydrochloride100 in 1 BOTTLE, PLASTICTABLET1002
63874-532-33Tramadol Hydrochloride30 in 1 BOTTLE, PLASTICTABLET302
63874-532-63Tramadol Hydrochloride60 in 1 BOTTLE, PLASTICTABLET602
63874-532-93Tramadol Hydrochloride90 in 1 BOTTLE, PLASTICTABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63874-532-00EA - Each63874-532487d669e-8b33-4152-a69e-ed16cdb30c4512012-07-24
63874-532-01EA - Each63874-532eb7dfba6-7e5c-4a3f-9edf-21399bf0446712012-07-24
63874-532-33EA - Each63874-53231ae2a35-7043-47fb-9d85-92e639ebeb1812012-07-24
63874-532-63EA - Each63874-53216eb4c09-ea0d-49ea-88d2-dcee4465ddf812012-07-24
63874-532-93EA - Each63874-532890ea1e6-2085-4e8d-bb3f-36d6665143fb12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET [ALTURA PHARMACEUTICALS, INC.]2
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET [ALTURA PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63874-532TRAMADOL HYDROCHLORIDE TABLET [ALTURA PHARMACEUTICALS, INC.]2Legacy NDC, 5 package rows20100428_4acbc6df-7616-413c-bcca-2be75a176dcf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSN4acbc6df-7616-413c-bcca-2be75a176dcf2
835603tramadol hydrochloride 50 MG Oral TabletSCD4acbc6df-7616-413c-bcca-2be75a176dcf2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63874-532-0063874053200120 in 1 BOTTLE, PLASTICHistorical
63874-532-0163874053201100 in 1 BOTTLE, PLASTICHistorical
63874-532-336387405323330 in 1 BOTTLE, PLASTICHistorical
63874-532-636387405326360 in 1 BOTTLE, PLASTICHistorical
63874-532-936387405329390 in 1 BOTTLE, PLASTICHistorical