Tramadol Hydrochloride

Product NDC
69467-1001
11-digit product format
694671001
Labeler code
69467
Product ID
69467-1001_92e4569c-9936-4ffe-8c3c-2221f7e71a4b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
STA3, LLC
Application
NDA022370
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2015-07-01
Marketing end
2020-08-31
Substance
TRAMADOL HYDROCHLORIDE
Active strength
150 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
0000-00-00
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69467-1001-1EA - Each69467-10014d0ce4b2-dd97-4564-a819-4ee4e7ae749e12015-09-10

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248115traMADol HCl 150 MG 24HR Extended Release Oral CapsulePSN4a135ba1-56b4-487a-bff1-74a850148cc81
1248115traMADol HCl 150 MG 24HR Extended Release Oral CapsulePSN5b3602f4-54f0-9461-e053-2a91aa0a99b91
1248115traMADol HCl 150 MG 24HR Extended Release Oral CapsulePSNfba82d4a-f015-4f1f-bca8-049096154c091
124811524 HR tramadol hydrochloride 150 MG Extended Release Oral CapsuleSCD4a135ba1-56b4-487a-bff1-74a850148cc81
124811524 HR tramadol hydrochloride 150 MG Extended Release Oral CapsuleSCD5b3602f4-54f0-9461-e053-2a91aa0a99b91
124811524 HR tramadol hydrochloride 150 MG Extended Release Oral CapsuleSCDfba82d4a-f015-4f1f-bca8-049096154c091
1248115tramadol HCl 150 MG 24 HR Extended Release Oral CapsuleSY4a135ba1-56b4-487a-bff1-74a850148cc81
1248115tramadol HCl 150 MG 24 HR Extended Release Oral CapsuleSY5b3602f4-54f0-9461-e053-2a91aa0a99b91
1248115tramadol HCl 150 MG 24 HR Extended Release Oral CapsuleSYfba82d4a-f015-4f1f-bca8-049096154c091