FDA.reportPublic FDA data

Doxycycline

Product NDC
0713-0429
11-digit product format
007130429
Labeler code
0713
Product ID
0713-0429_c0e92d78-81a0-449f-81bb-e8466699c309
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline
Dosage form
CAPSULE
Route
ORAL
Labeler
G&W Laboratories, Inc.
Application
ANDA204446
Marketing category
ANDA
Marketing start
2015-05-28
Marketing end
2019-09-30
Substance
DOXYCYCLINE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0713-0429DDiscontinued by firm2026-07-31
excluded packagepackage0713-04290713-0429-50DDiscontinued by firm2026-07-31
excluded packagepackage0713-04290713-0429-93DDiscontinued 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 · 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
0713-0429-50EA - Each0713-0429d2b781da-e29d-41ea-97bb-9b6709ee5d6f12016-05-16
0713-0429-93EA - Each0713-042975fc68e6-2810-418f-9ce1-8ff20363c48c12016-05-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649990doxycycline monohydrate 100 MG Oral CapsulePSN6aafcc8c-9bd5-d377-e053-2a91aa0a15142
1649990doxycycline monohydrate 100 MG Oral CapsuleSCD6aafcc8c-9bd5-d377-e053-2a91aa0a15142
1649990doxycycline monohydrate 100 MG Oral CapsulePSN33d5265e-b4fb-2d47-e054-00144ff88e881
205621Monodox 100 MG Oral CapsulePSN33d5265e-b4fb-2d47-e054-00144ff88e881
205621doxycycline monohydrate 100 MG Oral Capsule [Monodox]SBD33d5265e-b4fb-2d47-e054-00144ff88e881
1649990doxycycline monohydrate 100 MG Oral CapsuleSCD33d5265e-b4fb-2d47-e054-00144ff88e881
205621Monodox (as doxycycline monohydrate) 100 MG Oral CapsuleSY33d5265e-b4fb-2d47-e054-00144ff88e881
205621Monodox 100 MG Oral CapsuleSY33d5265e-b4fb-2d47-e054-00144ff88e881