FDA.reportPublic FDA data

Tramadol Hydrochloride

Product NDC
68180-383
11-digit product format
681800383
Labeler code
68180
Product ID
68180-383_e674f8e1-d70a-4e39-b2c3-6b7ad77e3796
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA200503
Marketing category
ANDA
Marketing start
2011-09-26
Substance
TRAMADOL HYDROCHLORIDE
Active strength
100 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 HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9N7R477WCK
Rxcui833709, 833711, 833713

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
68180-383-01Tramadol Hydrochloride100 in 1 BOTTLETABLET, EXTENDED RELEASE1006
68180-383-02Tramadol Hydrochloride500 in 1 BOTTLETABLET, EXTENDED RELEASE5006
68180-383-06Tramadol Hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-383TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]6Current NDC, 3 package rows20231215_3e0ccb95-3e8e-477c-b4d2-6060ee05f930.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833709traMADol HCl 100 MG 24HR Extended Release Oral TabletPSN3e0ccb95-3e8e-477c-b4d2-6060ee05f9306
833711traMADol HCl 200 MG 24HR Extended Release Oral TabletPSN3e0ccb95-3e8e-477c-b4d2-6060ee05f9306
833713traMADol HCl 300 MG 24HR Extended Release Oral TabletPSN3e0ccb95-3e8e-477c-b4d2-6060ee05f9306
83370924 HR tramadol hydrochloride 100 MG Extended Release Oral TabletSCD3e0ccb95-3e8e-477c-b4d2-6060ee05f9306
83371124 HR tramadol hydrochloride 200 MG Extended Release Oral TabletSCD3e0ccb95-3e8e-477c-b4d2-6060ee05f9306
83371324 HR tramadol hydrochloride 300 MG Extended Release Oral TabletSCD3e0ccb95-3e8e-477c-b4d2-6060ee05f9306
833711tramadol HCl 200 MG 24 HR Extended Release Oral TabletSY3e0ccb95-3e8e-477c-b4d2-6060ee05f9306
833709tramadol hydrochloride 100 MG 24 HR Extended Release Oral TabletSY3e0ccb95-3e8e-477c-b4d2-6060ee05f9306
833713tramadol hydrochloride 300 MG 24 HR Extended Release Oral TabletSY3e0ccb95-3e8e-477c-b4d2-6060ee05f9306

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68180-383-0168180038301100 in 1 BOTTLEHistorical
68180-383-0268180038302500 in 1 BOTTLEHistorical
68180-383-066818003830630 in 1 BOTTLEHistorical