FDA.reportPublic FDA data

Doxycycline

Product NDC
51655-350
11-digit product format
516550350
Labeler code
51655
Product ID
51655-350_49d7ff1e-293a-4374-e063-6394a90aad44
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA091605
Marketing category
ANDA
Marketing start
2022-11-29
Substance
DOXYCYCLINE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091605-001DOXYCYCLINEDOXYCYCLINEEQ 50MG BASETABLET / ORALAB2011-12-20
A091605-002DOXYCYCLINEDOXYCYCLINEEQ 75MG BASETABLET / ORALAB2011-12-20
A091605-003DOXYCYCLINEDOXYCYCLINEEQ 100MG BASETABLET / ORALAB2011-12-20
A091605-004DOXYCYCLINEDOXYCYCLINEEQ 150MG BASETABLET / ORALABRS2011-12-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A091605-001AB
A091605-002AB
A091605-003AB
A091605-004AB

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 22:54:322026-06A091605-001DOXYCYCLINEEQ 50MG BASETABLET / ORALAB2011-12-20a50c72e98297…
2026-08-01 22:54:322026-06A091605-002DOXYCYCLINEEQ 75MG BASETABLET / ORALAB2011-12-20a50c72e98297…
2026-08-01 22:54:322026-06A091605-003DOXYCYCLINEEQ 100MG BASETABLET / ORALAB2011-12-20a50c72e98297…
2026-08-01 22:54:322026-06A091605-004DOXYCYCLINEEQ 150MG BASETABLET / ORALABRS2011-12-20a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A091605-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A091605-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A091605-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A091605-004AB1a50c72e98297…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoxycyclineDOXYCYCLINEProficient Rx LP112c35d6-a397-45de-a57a-6e687cb27b4f2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091605
application number: ANDA091605
DoxycyclineDOXYCYCLINENorthwind Health Company, LLCf2f1ee15-9323-1263-e053-2995a90a01fa2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091605
application number: ANDA091605
ndc (product): 51655-350
DoxycyclineDOXYCYCLINEChartwell RX, LLC5bebf320-1395-43b9-9404-fe479d70b2402025-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091605
application number: ANDA091605
DoxycyclineDOXYCYCLINEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.2bcde264-5f6f-47f6-ae2e-1b7010deacf72025-07-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091605
application number: ANDA091605
DoxycyclineDOXYCYCLINEA-S Medication Solutions2b3b3c48-eb60-400c-bdfe-50635a136c902025-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091605
application number: ANDA091605

Additional Listing Data#

Finished product
Yes
Brand name base
Doxycycline
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE100 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
1650142Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f2f1ee15-9323-1263-e053-2995a90a01faAvailable 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
51655-350-20Doxycycline20 in 1 BOTTLE, PLASTICTABLET203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-350DOXYCYCLINE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1Current NDC, 1 package rows20230328_f2f1ee15-9323-1263-e053-2995a90a01fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650142doxycycline monohydrate 100 MG Oral TabletPSNf2f1ee15-9323-1263-e053-2995a90a01fa3
1650142doxycycline monohydrate 100 MG Oral TabletSCDf2f1ee15-9323-1263-e053-2995a90a01fa3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-350-205165503502020 TABLET in 1 BOTTLE, PLASTIC (51655-350-20) 20 tablet2022-11-29NoNoCurrent