FDA.reportPublic FDA data

Tramadol HCL

Product NDC
80425-0057
11-digit product format
804250057
Labeler code
80425
Product ID
80425-0057_2a98da36-e8b2-759b-e063-6294a90ab33b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol HCL
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA076003
Marketing category
ANDA
Marketing start
2010-11-15
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 HCL
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
80425-0057-1Tramadol HCL30 in 1 BOTTLETABLET, COATED309
80425-0057-2Tramadol HCL60 in 1 BOTTLETABLET, COATED609
80425-0057-3Tramadol HCL90 in 1 BOTTLETABLET, COATED909
80425-0057-4Tramadol HCL15 in 1 BOTTLETABLET, COATED159
80425-0057-5Tramadol HCL120 in 1 BOTTLETABLET, COATED1209

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0057-1EA - Each80425-0057504be37b-91ad-4507-a4aa-1f8cd3a6f86212023-03-13
80425-0057-2EA - Each80425-00574c02de54-897e-4e5b-ac17-54b2b024bb7912023-03-13
80425-0057-3EA - Each80425-0057ad860459-e36b-4269-87a3-ee63a4811db712023-03-13
80425-0057-4EA - Each80425-005753aa85da-c9bb-42b1-93bb-fd4d2d165c8512023-03-13
80425-0057-5EA - Each80425-0057998304a3-5bc5-44c3-ab3d-2e3b4e522fae12023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0057TRAMADOL HCL TABLET, COATED [ADVANCED RX OF TENNESSEE, LLC]9Current NDC, Legacy NDC, 5 package rows20250101_af87fc31-07c2-b1f7-e053-2995a90a499f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSNaf87fc31-07c2-b1f7-e053-2995a90a499f9
835603tramadol hydrochloride 50 MG Oral TabletSCDaf87fc31-07c2-b1f7-e053-2995a90a499f9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80425-0057-18042500570130 TABLET, COATED in 1 BOTTLE (80425-0057-1) 2010-11-150000-00-00NoNoCurrent
80425-0057-28042500570260 TABLET, COATED in 1 BOTTLE (80425-0057-2) 2010-11-150000-00-00NoNoCurrent
80425-0057-38042500570390 TABLET, COATED in 1 BOTTLE (80425-0057-3) 2010-11-150000-00-00NoNoCurrent
80425-0057-48042500570415 TABLET, COATED in 1 BOTTLE (80425-0057-4) 2010-11-150000-00-00NoNoCurrent
80425-0057-580425005705120 TABLET, COATED in 1 BOTTLE (80425-0057-5) 2010-11-150000-00-00NoNoCurrent