FDA.reportPublic FDA data

TRAMADOL HYDROCHLORIDE

Product NDC
47335-533
11-digit product format
473350533
Labeler code
47335
Product ID
47335-533_e080bc94-c122-41f3-8bda-0fb9318f8aa6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
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 HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRAMADOL HYDROCHLORIDE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9N7R477WCK
Rxcui1946525, 1946527, 1946529

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
47335-533-08TRAMADOL HYDROCHLORIDE100 in 1 BOTTLETABLET, EXTENDED RELEASE10028
47335-533-18TRAMADOL HYDROCHLORIDE1000 in 1 BOTTLETABLET, EXTENDED RELEASE100028
47335-533-83TRAMADOL HYDROCHLORIDE30 in 1 BOTTLETABLET, EXTENDED RELEASE3028
47335-533-88TRAMADOL HYDROCHLORIDE100 in 1 BOTTLETABLET, EXTENDED RELEASE10028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47335-533-83EA - Each47335-533f4697080-bf43-404e-8287-0fcf8ba56b1412012-07-24
47335-533-88EA - Each47335-533fb197cd0-7a2b-4b85-b852-18aa0997652812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]3
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]3
AMMONIAINACTIVE INGREDIENT5138Q19F1XTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]3
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]3
CELLULOSE ACETATEINACTIVE INGREDIENT3J2P07GVB6TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]3
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]3
MANNITOLINACTIVE INGREDIENT3OWL53L36ATRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]3
SHELLACINACTIVE INGREDIENT46N107B71OTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-533TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]24Current NDC, Legacy NDC, 4 package rows20240119_dc420d50-6192-482d-b3da-3be55870a79a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1946529traMADol hydrochloride 100 MG Matrix Delivery 24HR Extended Release Oral TabletPSNdc420d50-6192-482d-b3da-3be55870a79a28
1946527traMADol hydrochloride 200 MG Matrix Delivery 24HR Extended Release Oral TabletPSNdc420d50-6192-482d-b3da-3be55870a79a28
1946525traMADol hydrochloride 300 MG Matrix Delivery 24HR Extended Release Oral TabletPSNdc420d50-6192-482d-b3da-3be55870a79a28
1946529Matrix Delivery 24 HR tramadol hydrochloride 100 MG Extended Release Oral TabletSCDdc420d50-6192-482d-b3da-3be55870a79a28
1946527Matrix Delivery 24 HR tramadol hydrochloride 200 MG Extended Release Oral TabletSCDdc420d50-6192-482d-b3da-3be55870a79a28
1946525Matrix Delivery 24 HR tramadol hydrochloride 300 MG Extended Release Oral TabletSCDdc420d50-6192-482d-b3da-3be55870a79a28
1946529tramadol hydrochloride 100 MG Matrix Delivery 24 HR Extended Release Oral TabletSYdc420d50-6192-482d-b3da-3be55870a79a28
1946527tramadol hydrochloride 200 MG Matrix Delivery 24 HR Extended Release Oral TabletSYdc420d50-6192-482d-b3da-3be55870a79a28
1946525tramadol hydrochloride 300 MG Matrix Delivery 24 HR Extended Release Oral TabletSYdc420d50-6192-482d-b3da-3be55870a79a28
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
47335-533-0847335053308100 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-533-08) 2011-12-300000-00-00NoNoCurrent
47335-533-18473350533181000 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-533-18) 2011-12-300000-00-00NoNoCurrent
47335-533-834733505338330 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-533-83) 2011-12-300000-00-00NoNoCurrent
47335-533-8847335053388100 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-533-88) 2011-12-300000-00-00NoNoCurrent