FDA.reportPublic FDA data

Doxycycline

Product NDC
60505-4775
11-digit product format
605054775
Labeler code
60505
Product ID
60505-4775_25ff4cd8-a10a-1c3e-5360-edfd3ecd93a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline
Dosage form
CAPSULE
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA217170
Marketing category
ANDA
Marketing start
2024-10-31
Substance
DOXYCYCLINE
Active strength
40 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC], Tetracyclines [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
excluded packagepackage60505-477560505-4775-5DDiscontinued by firm2026-07-31

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
A217170-001DOXYCYCLINEDOXYCYCLINE40MGCAPSULE / ORALAB2024-07-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217170-001AB

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 22:54:322026-06A217170-001DOXYCYCLINE40MGCAPSULE / ORALAB2024-07-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A217170-001AB1a50c72e98297…

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
DoxycyclineDOXYCYCLINEApotex Corp.7fb99e0c-10f6-2924-7940-84e52e7e2a362025-09-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217170
application number: ANDA217170
ndc (product): 60505-4775
DoxycyclineDOXYCYCLINEAvKARE3dd8c11c-aa52-9e22-e063-6294a90a5cbd2025-09-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217170
application number: ANDA217170

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
N12000U13OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
901399Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7fb99e0c-10f6-2924-7940-84e52e7e2a36Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b4321c75-2e87-4d90-9726-9a28fb2293a3Product name320260112
5e99724e-0654-4aec-b7a2-0b9b10e312eeProduct name320250227
d2d36660-68ce-7e7d-0630-ec4b0d859fadProduct name620220921
a239f4dd-cf93-4660-b190-f97d000f249fProduct name720210607
a9d03566-caeb-4466-8021-74599b048880Product name320210604
12750814-20f7-4f35-b5fa-dbc8811ba858Product name920201007
00a5dbaa-1b7d-4e56-be0c-fedc7bbf5adeProduct name120200706
7b4b06ac-8c50-45f0-9556-293ea558a294Product name120180808
6a5b4392-5ab0-af0d-e0be-47b34e9dbb84Product name520171121
01a4aa74-7e05-63bd-bc10-1b5ceb111371Product name220171115
58b1278c-6dce-49b6-a05e-ea16f389acbaProduct name120160620

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-4775-3Doxycycline30 in 1 BOTTLECAPSULE304
60505-4775-5Doxycycline500 in 1 BOTTLECAPSULE5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-4775-3EA - Each60505-4775e070eef7-7aeb-4998-b5d2-2a9db2b2609d12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-4775DOXYCYCLINE CAPSULE [APOTEX CORP.]2Current NDC, 2 package rows20241102_7fb99e0c-10f6-2924-7940-84e52e7e2a36.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
901399doxycycline anhydrous 40 MG Delayed Release Oral CapsulePSN7fb99e0c-10f6-2924-7940-84e52e7e2a364
901399doxycycline anhydrous 40 MG Delayed Release Oral CapsuleSCD7fb99e0c-10f6-2924-7940-84e52e7e2a364
901399doxycycline anhydrous 40 MG Delayed Release Oral CapsulePSN3dd8c11c-aa52-9e22-e063-6294a90a5cbd1
901399doxycycline anhydrous 40 MG Delayed Release Oral CapsuleSCD3dd8c11c-aa52-9e22-e063-6294a90a5cbd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60505-4775-36050547750330 CAPSULE in 1 BOTTLE (60505-4775-3) 30 capsule2024-10-31NoNoCurrent
60505-4775-560505477505500 in 1 BOTTLEHistorical