FDA.reportPublic FDA data

tramadol hydrochloride

Product NDC
68071-3644
11-digit product format
680713644
Labeler code
68071
Product ID
68071-3644_23aab36b-87f1-4569-e063-6394a90aae17
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tramadol hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA202075
Marketing category
ANDA
Marketing start
2018-03-01
Substance
TRAMADOL HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
tramadol hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRAMADOL HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9N7R477WCK
Rxcui835603

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3644-3tramadol hydrochloride30 in 1 PACKAGETABLET305
68071-3644-4tramadol hydrochloride40 in 1 PACKAGETABLET405
68071-3644-5tramadol hydrochloride15 in 1 PACKAGETABLET155
68071-3644-6tramadol hydrochloride60 in 1 PACKAGETABLET605
68071-3644-9tramadol hydrochloride90 in 1 PACKAGETABLET905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3644TRAMADOL HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS, INC.]5Current NDC, 5 package rows20241006_1cd3caee-bf54-7aba-e063-6394a90ad8cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSN1cd3caee-bf54-7aba-e063-6394a90ad8cb5
835603tramadol hydrochloride 50 MG Oral TabletSCD1cd3caee-bf54-7aba-e063-6394a90ad8cb5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3644-36807136440330 TABLET in 1 PACKAGE (68071-3644-3) 30 tablet2024-07-09NoNoHistorical
68071-3644-46807136440440 TABLET in 1 PACKAGE (68071-3644-4) 40 tablet2024-09-10NoNoHistorical
68071-3644-56807136440515 TABLET in 1 PACKAGE (68071-3644-5) 15 tablet2024-07-09NoNoHistorical
68071-3644-66807136440660 TABLET in 1 PACKAGE (68071-3644-6) 60 tablet2024-09-03NoNoHistorical
68071-3644-96807136440990 TABLET in 1 PACKAGE (68071-3644-9) 90 tablet2024-07-09NoNoHistorical