FDA.reportPublic FDA data

Colchicine

Product NDC
59651-446
Requested package NDC
59651-446-91
11-digit product format
596510446
Labeler code
59651
Product ID
59651-446_4ccdf563-ca5a-439d-acdd-35067133be31
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colchicine
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA215463
Marketing category
ANDA
Marketing start
2024-04-29
Substance
COLCHICINE
Active strength
.6 mg/1
Pharmacologic classes
Alkaloid [EPC], Alkaloids [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished packagepackage59651-44659651-446-91UNFINISHEDActive or certified unfinished drug listing2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A215463-001COLCHICINECOLCHICINE0.6MGCAPSULE / ORALAB2024-04-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A215463-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A215463-001COLCHICINE0.6MGCAPSULE / ORALAB2024-04-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A215463-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ColchicineCOLCHICINEBryant Ranch Prepackd83c6ae4-a41c-4b14-94b3-2d93c9aa28d12025-09-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215463
application number: ANDA215463
ColchicineCOLCHICINEAurobindo Pharma Limiteda1ff526f-e89f-4dca-80b6-653d6bdfd8952025-07-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215463
application number: ANDA215463
ndc (product): 59651-446

Additional Listing Data#

Finished product
Yes
Brand name base
Colchicine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COLCHICINE.6 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SML2Y3J35TInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1550940Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a1ff526f-e89f-4dca-80b6-653d6bdfd895Available on FDA.report

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
59651-446-01Colchicine100 in 1 BOTTLECAPSULE1003
59651-446-30Colchicine30 in 1 BOTTLECAPSULE303
59651-446-99Colchicine1000 in 1 BOTTLECAPSULE10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-446-01EA - Each59651-4464c20e7ca-8990-4821-b08c-a55e70df279d12024-05-16
59651-446-30EA - Each59651-44688b371a0-7583-4cac-9283-201120874f4812025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-446COLCHICINE CAPSULE [AUROBINDO PHARMA LIMITED]2Current NDC, 3 package rows20240706_a1ff526f-e89f-4dca-80b6-653d6bdfd895.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1550940colchicine 0.6 MG Oral CapsulePSNa1ff526f-e89f-4dca-80b6-653d6bdfd8953
1550940colchicine 0.6 MG Oral CapsuleSCDa1ff526f-e89f-4dca-80b6-653d6bdfd8953
1550940colchicine 0.6 MG Oral CapsulePSNd83c6ae4-a41c-4b14-94b3-2d93c9aa28d11
1550940colchicine 0.6 MG Oral CapsuleSCDd83c6ae4-a41c-4b14-94b3-2d93c9aa28d11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startStatus
59651-446-9159651044691100000 CAPSULE in 1 BAG (59651-446-91)100000 capsule29-APR-24Current