Tramadol Hydrochloride

Product NDC
61919-583
11-digit product format
619190583
Labeler code
61919
Product ID
61919-583_584cc232-9a02-440d-9c4d-6e529f301f18
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct Rx
Application
NDA022370
Marketing category
NDA
Marketing start
2015-01-01
Marketing end
0000-00-00
Substance
TRAMADOL HYDROCHLORIDE
Active strength
150 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-583-30Tramadol Hydrochloride30 in 1 BOTTLECAPSULE301
61919-583-60Tramadol Hydrochloride60 in 1 BOTTLECAPSULE601
61919-583-72Tramadol Hydrochloride120 in 1 BOTTLECAPSULE1201
61919-583-90Tramadol Hydrochloride90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-583-30EA - Each61919-583802eb7e7-93b3-495f-91a0-e258d518820712016-09-02
61919-583-60EA - Each61919-583a7a8ed1c-52af-4f84-a5e8-708a9544023d12016-09-02
61919-583-72EA - Each61919-5836cadf712-a8df-4d80-a7f7-a8996ad08a0012016-09-02
61919-583-90EA - Each61919-583ba0ebc7d-11e2-4aa9-850e-ba52a5838d5412016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE CAPSULE [DIRECT RX]1
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE CAPSULE [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE CAPSULE [DIRECT RX]1
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)INACTIVE INGREDIENTP2OM2Q86BITRAMADOL HYDROCHLORIDE CAPSULE [DIRECT RX]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTRAMADOL HYDROCHLORIDE CAPSULE [DIRECT RX]1
GELATININACTIVE INGREDIENT2G86QN327LTRAMADOL HYDROCHLORIDE CAPSULE [DIRECT RX]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRAMADOL HYDROCHLORIDE CAPSULE [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE CAPSULE [DIRECT RX]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTRAMADOL HYDROCHLORIDE CAPSULE [DIRECT RX]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XTRAMADOL HYDROCHLORIDE CAPSULE [DIRECT RX]1
SHELLACINACTIVE INGREDIENT46N107B71OTRAMADOL HYDROCHLORIDE CAPSULE [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE CAPSULE [DIRECT RX]1
SUCROSE STEARATEINACTIVE INGREDIENT274KW0O50MTRAMADOL HYDROCHLORIDE CAPSULE [DIRECT RX]1
TALCINACTIVE INGREDIENT7SEV7J4R1UTRAMADOL HYDROCHLORIDE CAPSULE [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAMADOL HYDROCHLORIDE CAPSULE [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-583TRAMADOL HYDROCHLORIDE CAPSULE [DIRECT RX]1Legacy NDC, 4 package rows20150919_1e2e4814-b916-46d5-99a3-3a0a3127e74e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-583-306191905833030 in 1 BOTTLEHistorical
61919-583-606191905836060 in 1 BOTTLEHistorical
61919-583-7261919058372120 in 1 BOTTLEHistorical
61919-583-906191905839090 in 1 BOTTLEHistorical