FDA.reportPublic FDA data

Doxycycline

Product NDC
0713-0570
11-digit product format
007130570
Labeler code
0713
Product ID
0713-0570_7603372c-888b-43c2-9753-aa38ce0b0ee3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline
Dosage form
CAPSULE
Route
ORAL
Labeler
Cosette Pharmaceuticals, Inc.
Application
ANDA204446
Marketing category
ANDA
Marketing start
2015-05-28
Marketing end
0000-00-00
Substance
DOXYCYCLINE
Active strength
50 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0713-0570DDiscontinued by firm2026-08-03
excluded packagepackage0713-05700713-0570-01DDiscontinued by firm2026-08-03

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204446-001DOXYCYCLINEDOXYCYCLINEEQ 50MG BASECAPSULE / ORAL2015-05-28
A204446-002DOXYCYCLINEDOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2015-05-28
A204446-003DOXYCYCLINEDOXYCYCLINEEQ 100MG BASECAPSULE / ORAL2015-05-28

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 22:54:322026-06A204446-001DOXYCYCLINEEQ 50MG BASECAPSULE / ORAL2015-05-28a50c72e98297…
2026-08-01 22:54:322026-06A204446-002DOXYCYCLINEEQ 75MG BASECAPSULE / ORAL2015-05-28a50c72e98297…
2026-08-01 22:54:322026-06A204446-003DOXYCYCLINEEQ 100MG BASECAPSULE / ORAL2015-05-28a50c72e98297…

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
DOXYCYCLINEDOXYCYCLINEDIRECT RX31512ece-cb16-2a9a-e054-00144ff88e882026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204446
application number: ANDA204446
DoxycyclineDOXYCYCLINELupin Pharmaceuticals,Inc.6512bf22-c211-4127-a8c8-2419656580f62024-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204446
application number: ANDA204446

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0570-01EA - Each0713-0570a8d2a5f3-9c06-47a0-97f1-a196fdc0336512021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0570DOXYCYCLINE CAPSULE [COSETTE PHARMACEUTICALS, INC.]2Legacy NDC20241215_a990e1bd-e126-43eb-84dc-2537a5f0ff94.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0713-0570-0100713057001100 CAPSULE in 1 BOTTLE (0713-0570-01) 100 capsule2021-07-010000-00-00NoNoCurrent