FDA.reportPublic FDA data

TRAMADOL HYDROCHLORIDE

Product NDC
71335-1676
11-digit product format
713351676
Labeler code
71335
Product ID
71335-1676_1deef20f-0585-445c-91bc-d4d25e97c0bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA201384
Marketing category
ANDA
Marketing start
2011-12-12
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TRAMADOL HYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRAMADOL HYDROCHLORIDE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9N7R477WCK
Rxcui833711

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
71335-1676-1TRAMADOL HYDROCHLORIDE30 in 1 BOTTLETABLET, EXTENDED RELEASE306
71335-1676-2TRAMADOL HYDROCHLORIDE60 in 1 BOTTLETABLET, EXTENDED RELEASE606
71335-1676-3TRAMADOL HYDROCHLORIDE90 in 1 BOTTLETABLET, EXTENDED RELEASE906
71335-1676-4TRAMADOL HYDROCHLORIDE120 in 1 BOTTLETABLET, EXTENDED RELEASE1206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1676TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 4 package rows20240410_66359f41-9999-4cb8-b632-1fe2ec1e60b2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833711traMADol HCl 200 MG 24HR Extended Release Oral TabletPSN66359f41-9999-4cb8-b632-1fe2ec1e60b26
83371124 HR tramadol hydrochloride 200 MG Extended Release Oral TabletSCD66359f41-9999-4cb8-b632-1fe2ec1e60b26
833711tramadol HCl 200 MG 24 HR Extended Release Oral TabletSY66359f41-9999-4cb8-b632-1fe2ec1e60b26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1676-17133516760130 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1676-1) 2020-07-100000-00-00NoNoCurrent
71335-1676-27133516760260 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1676-2) 2020-07-080000-00-00NoNoCurrent
71335-1676-37133516760390 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1676-3) 2020-08-130000-00-00NoNoCurrent
71335-1676-471335167604120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1676-4) 2024-04-040000-00-00NoNoCurrent