FDA.reportPublic FDA data

Tramadol Hydrochloride

Product NDC
80425-0501
11-digit product format
804250501
Labeler code
80425
Product ID
80425-0501_2e738ab3-ae9a-9416-e063-6394a90afc75
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA076003
Marketing category
ANDA
Marketing start
2025-02-13
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
80425-0501-1Tramadol Hydrochloride15 in 1 BOTTLETABLET, COATED151
80425-0501-2Tramadol Hydrochloride30 in 1 BOTTLETABLET, COATED301
80425-0501-3Tramadol Hydrochloride60 in 1 BOTTLETABLET, COATED601
80425-0501-4Tramadol Hydrochloride90 in 1 BOTTLETABLET, COATED901
80425-0501-5Tramadol Hydrochloride120 in 1 BOTTLETABLET, COATED1201
80425-0501-6Tramadol Hydrochloride40 in 1 BOTTLETABLET, COATED401
80425-0501-7Tramadol Hydrochloride180 in 1 BOTTLETABLET, COATED1801
80425-0501-8Tramadol Hydrochloride240 in 1 BOTTLETABLET, COATED2401

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0501-1EA - Each80425-05015b367eca-98d7-4034-a218-38197df636e712025-03-04
80425-0501-2EA - Each80425-0501b9cf99f9-897c-4f4f-94f6-3ccaf4f83a9212025-03-04
80425-0501-3EA - Each80425-0501b7c9bbe8-370c-428d-b7d8-916758373a8912025-03-04
80425-0501-4EA - Each80425-0501756c208b-56a5-4df6-9f17-65c41677bde512025-03-04
80425-0501-5EA - Each80425-05011f8064f3-66bb-4859-850f-f42fbc72a96c12025-03-04
80425-0501-6EA - Each80425-0501f406d2e2-a3ba-40aa-a5a7-fa458eceb81e12025-03-04
80425-0501-7EA - Each80425-05016f965c02-75e5-44aa-b55a-feb03d48262612025-03-04
80425-0501-8EA - Each80425-0501bf6a096b-a9fc-4ba5-92c8-38303e66a4ab12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0501TRAMADOL HYDROCHLORIDE TABLET, COATED [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 8 package rows20250221_2e738ced-9cde-e776-e063-6294a90a7e33.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSN2e738ced-9cde-e776-e063-6294a90a7e331
835603tramadol hydrochloride 50 MG Oral TabletSCD2e738ced-9cde-e776-e063-6294a90a7e331

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80425-0501-18042505010115 TABLET, COATED in 1 BOTTLE (80425-0501-1) 2025-02-13NoNoHistorical
80425-0501-28042505010230 TABLET, COATED in 1 BOTTLE (80425-0501-2) 2025-02-13NoNoHistorical
80425-0501-38042505010360 TABLET, COATED in 1 BOTTLE (80425-0501-3) 2025-02-13NoNoHistorical
80425-0501-48042505010490 TABLET, COATED in 1 BOTTLE (80425-0501-4) 2025-02-13NoNoHistorical
80425-0501-580425050105120 TABLET, COATED in 1 BOTTLE (80425-0501-5) 2025-02-13NoNoHistorical
80425-0501-68042505010640 TABLET, COATED in 1 BOTTLE (80425-0501-6) 2025-02-13NoNoHistorical
80425-0501-780425050107180 TABLET, COATED in 1 BOTTLE (80425-0501-7) 2025-02-13NoNoHistorical
80425-0501-880425050108240 TABLET, COATED in 1 BOTTLE (80425-0501-8) 2025-02-13NoNoHistorical