FDA.reportPublic FDA data

Tramadol Hydrochloride

Product NDC
80425-0548
11-digit product format
804250548
Labeler code
80425
Product ID
80425-0548_4641b78d-bdc6-12d5-e063-6394a90a728a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA211825
Marketing category
ANDA
Marketing start
2025-08-27
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
80425-0548-1Tramadol Hydrochloride15 in 1 BOTTLE, PLASTICTABLET, FILM COATED153
80425-0548-2Tramadol Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED303
80425-0548-3Tramadol Hydrochloride60 in 1 BOTTLE, PLASTICTABLET, FILM COATED603
80425-0548-4Tramadol Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED903
80425-0548-5Tramadol Hydrochloride120 in 1 BOTTLE, PLASTICTABLET, FILM COATED1203
80425-0548-6Tramadol Hydrochloride40 in 1 BOTTLE, PLASTICTABLET, FILM COATED403
80425-0548-7Tramadol Hydrochloride180 in 1 BOTTLE, PLASTICTABLET, FILM COATED1803
80425-0548-8Tramadol Hydrochloride240 in 1 BOTTLE, PLASTICTABLET, FILM COATED2403

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0548-1EA - Each80425-0548bad65c76-d3f9-490b-97a4-175d3cf4e8ea12025-10-14
80425-0548-2EA - Each80425-054881760d91-3fda-43a4-87af-12e9bb389f3112025-10-14
80425-0548-3EA - Each80425-054839474083-7a93-412d-aaca-4997d711728f12025-10-14
80425-0548-4EA - Each80425-0548de095b93-e887-4eb2-aa18-f27ce88fc8eb12025-10-14
80425-0548-5EA - Each80425-05480c4cab16-c419-4fbd-b834-3710053b29fb12025-10-14
80425-0548-6EA - Each80425-0548e248b839-4c7c-4281-bd75-adb0d7ba0d3312025-10-14
80425-0548-7EA - Each80425-0548d677fc0c-e3a1-4fde-91b1-b20c5356ac9712025-10-14
80425-0548-8EA - Each80425-0548341ea764-5f75-4740-843d-b09626eda49212025-10-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSN3d719560-7449-f970-e063-6294a90a9bd83
835603tramadol hydrochloride 50 MG Oral TabletSCD3d719560-7449-f970-e063-6294a90a9bd83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80425-0548-18042505480115 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-1) 2025-08-27NoNoHistorical
80425-0548-28042505480230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-2) 2025-08-27NoNoHistorical
80425-0548-38042505480360 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-3) 2025-08-27NoNoHistorical
80425-0548-48042505480490 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-4) 2025-08-27NoNoHistorical
80425-0548-580425054805120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-5) 2025-08-27NoNoHistorical
80425-0548-68042505480640 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-6) 2025-08-27NoNoHistorical
80425-0548-780425054807180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-7) 2025-08-27NoNoHistorical
80425-0548-880425054808240 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-8) 2025-08-27NoNoHistorical