TRAMADOL HYDROCHLORIDE

Product NDC
55700-996
11-digit product format
557000996
Labeler code
55700
Product ID
55700-996_77c7c0be-a1bf-4912-b895-77bdcfe7c67f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA200503
Marketing category
ANDA
Marketing start
2023-01-24
Marketing end
2027-01-31
Substance
TRAMADOL HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CIV
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TRAMADOL HYDROCHLORIDE

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRAMADOL HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9N7R477WCK
Rxcui833709

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
55700-996-30TRAMADOL HYDROCHLORIDE30 in 1 BOTTLETABLET, EXTENDED RELEASE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-996-30EA - Each55700-9967fd06ab3-6ab2-423a-a9cf-842cd60b8a5d12023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-996TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE [QUALITY CARE PRODUCTS, LLC]2Current NDC, 1 package rows20241222_7e421fb6-737c-49b3-b299-50511e281a4d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833709traMADol HCl 100 MG 24HR Extended Release Oral TabletPSN7e421fb6-737c-49b3-b299-50511e281a4d2
83370924 HR tramadol hydrochloride 100 MG Extended Release Oral TabletSCD7e421fb6-737c-49b3-b299-50511e281a4d2
833709tramadol hydrochloride 100 MG 24 HR Extended Release Oral TabletSY7e421fb6-737c-49b3-b299-50511e281a4d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-996-305570009963030 TABLET, EXTENDED RELEASE in 1 BOTTLE (55700-996-30) 2023-01-242027-01-31NoNoHistorical