FDA.reportPublic FDA data

Tramadol Hydrochloride

Product NDC
13811-689
11-digit product format
138110689
Labeler code
13811
Product ID
13811-689_0e535876-333d-4ac4-8cdf-847613083c06
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tramadol hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Trigen Laboratories, LLC
Application
NDA022370
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2015-06-22
Substance
TRAMADOL HYDROCHLORIDE
Active strength
100 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
Brand name suffix
Extended-Release
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRAMADOL HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9N7R477WCK
Rxcui1148478, 1148485, 1148489

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
13811-689-30Tramadol HydrochlorideExtended-Release30 in 1 BOTTLE, PLASTICCAPSULE3016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13811-689-30EA - Each13811-689ad5c22f8-d4ca-43a2-8754-948600226ac312015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE EXTENDED-RELEASE (TRAMADOL HYDROCHLORIDE) CAPSULE [TRIGEN LABORATORIES, LLC]2
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE EXTENDED-RELEASE (TRAMADOL HYDROCHLORIDE) CAPSULE [TRIGEN LABORATORIES, LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE EXTENDED-RELEASE (TRAMADOL HYDROCHLORIDE) CAPSULE [TRIGEN LABORATORIES, LLC]2
D&C RED NO. 7INACTIVE INGREDIENTECW0LZ41X8TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE (TRAMADOL HYDROCHLORIDE) CAPSULE [TRIGEN LABORATORIES, LLC]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTRAMADOL HYDROCHLORIDE EXTENDED-RELEASE (TRAMADOL HYDROCHLORIDE) CAPSULE [TRIGEN LABORATORIES, LLC]2
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)INACTIVE INGREDIENTP2OM2Q86BITRAMADOL HYDROCHLORIDE EXTENDED-RELEASE (TRAMADOL HYDROCHLORIDE) CAPSULE [TRIGEN LABORATORIES, LLC]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTRAMADOL HYDROCHLORIDE EXTENDED-RELEASE (TRAMADOL HYDROCHLORIDE) CAPSULE [TRIGEN LABORATORIES, LLC]2
GELATININACTIVE INGREDIENT2G86QN327LTRAMADOL HYDROCHLORIDE EXTENDED-RELEASE (TRAMADOL HYDROCHLORIDE) CAPSULE [TRIGEN LABORATORIES, LLC]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE (TRAMADOL HYDROCHLORIDE) CAPSULE [TRIGEN LABORATORIES, LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRAMADOL HYDROCHLORIDE EXTENDED-RELEASE (TRAMADOL HYDROCHLORIDE) CAPSULE [TRIGEN LABORATORIES, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE (TRAMADOL HYDROCHLORIDE) CAPSULE [TRIGEN LABORATORIES, LLC]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTRAMADOL HYDROCHLORIDE EXTENDED-RELEASE (TRAMADOL HYDROCHLORIDE) CAPSULE [TRIGEN LABORATORIES, LLC]2
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQTRAMADOL HYDROCHLORIDE EXTENDED-RELEASE (TRAMADOL HYDROCHLORIDE) CAPSULE [TRIGEN LABORATORIES, LLC]2
SHELLACINACTIVE INGREDIENT46N107B71OTRAMADOL HYDROCHLORIDE EXTENDED-RELEASE (TRAMADOL HYDROCHLORIDE) CAPSULE [TRIGEN LABORATORIES, LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE EXTENDED-RELEASE (TRAMADOL HYDROCHLORIDE) CAPSULE [TRIGEN LABORATORIES, LLC]2
SUCROSE STEARATEINACTIVE INGREDIENT274KW0O50MTRAMADOL HYDROCHLORIDE EXTENDED-RELEASE (TRAMADOL HYDROCHLORIDE) CAPSULE [TRIGEN LABORATORIES, LLC]2
TALCINACTIVE INGREDIENT7SEV7J4R1UTRAMADOL HYDROCHLORIDE EXTENDED-RELEASE (TRAMADOL HYDROCHLORIDE) CAPSULE [TRIGEN LABORATORIES, LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAMADOL HYDROCHLORIDE EXTENDED-RELEASE (TRAMADOL HYDROCHLORIDE) CAPSULE [TRIGEN LABORATORIES, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13811-689TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE (TRAMADOL HYDROCHLORIDE) CAPSULE [TRIGEN LABORATORIES, LLC]15Current NDC, Legacy NDC, 1 package rows20240328_c0bc7218-3fd0-4646-96f4-25355fc84aa9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148478traMADol HCl 100 MG 24HR Extended Release Oral CapsulePSNc0bc7218-3fd0-4646-96f4-25355fc84aa916
1148485traMADol HCl 200 MG 24HR Extended Release Oral CapsulePSNc0bc7218-3fd0-4646-96f4-25355fc84aa916
1148489traMADol HCl 300 MG 24HR Extended Release Oral CapsulePSNc0bc7218-3fd0-4646-96f4-25355fc84aa916
114847824 HR tramadol hydrochloride 100 MG Extended Release Oral CapsuleSCDc0bc7218-3fd0-4646-96f4-25355fc84aa916
114848524 HR tramadol hydrochloride 200 MG Extended Release Oral CapsuleSCDc0bc7218-3fd0-4646-96f4-25355fc84aa916
114848924 HR tramadol hydrochloride 300 MG Extended Release Oral CapsuleSCDc0bc7218-3fd0-4646-96f4-25355fc84aa916
1148485tramadol hydrochloride 200 MG 24 HR Extended Release Oral CapsuleSYc0bc7218-3fd0-4646-96f4-25355fc84aa916
1148489tramadol hydrochloride 300 MG 24 HR Extended Release Oral CapsuleSYc0bc7218-3fd0-4646-96f4-25355fc84aa916

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13811-689-301381106893030 CAPSULE in 1 BOTTLE, PLASTIC (13811-689-30) 30 capsule2015-06-220000-00-00NoNoCurrent