FDA.reportPublic FDA data

Tramadol Hydrochloride

Product NDC
68788-4035
11-digit product format
687884035
Labeler code
68788
Product ID
68788-4035_e6e275c3-1e16-4a00-b7fd-608ae6cbd515
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA211825
Marketing category
ANDA
Marketing start
2025-09-29
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
68788-4035-1Tramadol Hydrochloride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1001
68788-4035-2Tramadol Hydrochloride20 in 1 BOTTLE, PLASTICTABLET, FILM COATED201
68788-4035-3Tramadol Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301
68788-4035-4Tramadol Hydrochloride40 in 1 BOTTLE, PLASTICTABLET, FILM COATED401
68788-4035-5Tramadol Hydrochloride15 in 1 BOTTLE, PLASTICTABLET, FILM COATED151
68788-4035-6Tramadol Hydrochloride60 in 1 BOTTLE, PLASTICTABLET, FILM COATED601
68788-4035-7Tramadol Hydrochloride60 in 1 BOTTLE, PLASTICTABLET, FILM COATED601
68788-4035-8Tramadol Hydrochloride120 in 1 BOTTLE, PLASTICTABLET, FILM COATED1201
68788-4035-9Tramadol Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSNe6e275c3-1e16-4a00-b7fd-608ae6cbd5151
835603tramadol hydrochloride 50 MG Oral TabletSCDe6e275c3-1e16-4a00-b7fd-608ae6cbd5151

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-4035-168788403501100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4035-1) 2025-09-29NoNoHistorical
68788-4035-26878840350220 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4035-2) 2025-09-29NoNoHistorical
68788-4035-36878840350330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4035-3) 2025-09-29NoNoHistorical
68788-4035-46878840350440 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4035-4) 2025-09-29NoNoHistorical
68788-4035-56878840350515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4035-5) 2025-09-29NoNoHistorical
68788-4035-66878840350660 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4035-6) 2025-09-29NoNoHistorical
68788-4035-76878840350760 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4035-7) 2025-09-29NoNoHistorical
68788-4035-868788403508120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4035-8) 2025-09-29NoNoHistorical
68788-4035-96878840350990 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4035-9) 2025-09-29NoNoHistorical