FDA.reportPublic FDA data

LODOCO

Product NDC
82867-001
11-digit product format
828670001
Labeler code
82867
Product ID
82867-001_247fc59c-53cc-90da-e063-6394a90aac8d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colchicine Tablets 0.5 mg
Dosage form
TABLET
Route
ORAL
Labeler
AGEPHA Pharma USA, LLC
Application
NDA215727
Marketing category
NDA
Marketing start
2023-06-16
Substance
COLCHICINE
Active strength
.5 mg/1
Pharmacologic classes
Alkaloid [EPC], Alkaloids [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COLCHICINE.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSML2Y3J35T
Rxcui197540, 2663988

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
51989a2b-944a-b31f-835e-469c133570adProduct name220250716
11e940b0-77bd-45d4-a80f-028ff6bd67e2Product name220250214
14efe2b0-2695-4943-8b2f-24f519c99fedProduct name120231023
bf4e8ffd-8f13-3050-5248-581676b7ea42Product name620221214
987af351-b977-4822-ac44-c76d29e24e78Product name120190611

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82867-001-01LODOCO30 in 1 BLISTER PACKTABLET303
82867-001-01LODOCO1 in 1 CARTONTABLET13
82867-001-02LODOCO1 in 1 CARTONTABLET13
82867-001-02LODOCO30 in 1 BLISTER PACKTABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82867-001LODOCO (COLCHICINE TABLETS 0.5 MG) TABLET [AGEPHA PHARMA USA, LLC]2Current NDC, 4 package rows20240828_ff06d68f-d65f-d097-e053-6294a90a7e5f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197540colchicine 0.5 MG Oral TabletPSNff06d68f-d65f-d097-e053-6294a90a7e5f3
2663988LODOCO 0.5 MG Oral TabletPSNff06d68f-d65f-d097-e053-6294a90a7e5f3
2663988colchicine 0.5 MG Oral Tablet [Lodoco]SBDff06d68f-d65f-d097-e053-6294a90a7e5f3
197540colchicine 0.5 MG Oral TabletSCDff06d68f-d65f-d097-e053-6294a90a7e5f3
2663988Lodoco 0.5 MG Oral TabletSYff06d68f-d65f-d097-e053-6294a90a7e5f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82867-001-01828670001011 BLISTER PACK in 1 CARTON (82867-001-01) / 30 TABLET in 1 BLISTER PACK1 blister pack2023-06-16NoNoCurrent
82867-001-02828670001021 BLISTER PACK in 1 CARTON (82867-001-02) / 30 TABLET in 1 BLISTER PACK1 blister pack2023-06-16YesNoCurrent