FDA.reportPublic FDA data

Tramadol HCL

Product NDC
80425-0127
11-digit product format
804250127
Labeler code
80425
Product ID
80425-0127_2a99a7c1-c4ba-2b01-e063-6294a90aa3b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol HCL
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA091607
Marketing category
ANDA
Marketing start
2011-12-30
Substance
TRAMADOL HYDROCHLORIDE
Active strength
200 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
Brand name suffix
ER
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRAMADOL HYDROCHLORIDE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9N7R477WCK
Rxcui1946527

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
80425-0127-1Tramadol HCLER30 in 1 BOTTLETABLET, EXTENDED RELEASE306
80425-0127-2Tramadol HCLER60 in 1 BOTTLETABLET, EXTENDED RELEASE606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0127-1EA - Each80425-012741f3ca04-56ba-48c6-a5c2-edc94654d6ee12023-03-13
80425-0127-2EA - Each80425-01271fb9eed3-5f2c-4443-b67e-ff4a2732eae212023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0127TRAMADOL HCL ER (TRAMADOL HCL) TABLET, EXTENDED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]6Current NDC, Legacy NDC, 2 package rows20250101_bba287fe-fbf6-65a9-e053-2a95a90a9237.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1946527traMADol hydrochloride 200 MG Matrix Delivery 24HR Extended Release Oral TabletPSNbba287fe-fbf6-65a9-e053-2a95a90a92376
1946527Matrix Delivery 24 HR tramadol hydrochloride 200 MG Extended Release Oral TabletSCDbba287fe-fbf6-65a9-e053-2a95a90a92376
1946527tramadol hydrochloride 200 MG Matrix Delivery 24 HR Extended Release Oral TabletSYbba287fe-fbf6-65a9-e053-2a95a90a92376

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80425-0127-18042501270130 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0127-1) 2011-12-300000-00-00NoNoCurrent
80425-0127-28042501270260 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0127-2) 2011-12-300000-00-00NoNoCurrent