FDA.reportPublic FDA data

Colchicine

Product NDC
60687-727
11-digit product format
606870727
Labeler code
60687
Product ID
60687-727_4f082c98-13b5-9cd0-e063-6294a90a89b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colchicine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA203976
Marketing category
ANDA
Marketing start
2023-08-01
Substance
COLCHICINE
Active strength
.6 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
Colchicine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COLCHICINE.6 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSML2Y3J35T
Rxcui197541

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
60687-727-11Colchicine1 in 1 BLISTER PACKTABLET, FILM COATED17
60687-727-21Colchicine30 in 1 CARTONTABLET, FILM COATED307
60687-727-65Colchicine50 in 1 CARTONTABLET, FILM COATED507

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-727-11EA - Each60687-727b3509152-6b0c-4f1a-a217-d489e99fdc6612023-08-08
60687-727-21EA - Each60687-727de1035f7-b895-4ac6-a2df-0af6a3707ac212023-08-08
60687-727-65EA - Each60687-727d7810987-6f53-4108-85d8-2abe0760b69c12026-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-727COLCHICINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3Current NDC, 3 package rows20241208_4b79a786-3f9e-4dad-aa66-bae5f299b966.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197541colchicine 0.6 MG Oral TabletPSN4b79a786-3f9e-4dad-aa66-bae5f299b9667
197541colchicine 0.6 MG Oral TabletSCD4b79a786-3f9e-4dad-aa66-bae5f299b9667
197541colchicine 600 MCG Oral TabletSY4b79a786-3f9e-4dad-aa66-bae5f299b9667

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-727-11606870727111 in 1 BLISTER PACKHistorical
60687-727-216068707272130 BLISTER PACK in 1 CARTON (60687-727-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-727-11) 30 blister pack2023-08-01NoNoHistorical
60687-727-656068707276550 BLISTER PACK in 1 CARTON (60687-727-65) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-727-11) 50 blister pack2026-04-08NoNoHistorical