FDA.reportPublic FDA data

Doxycycline

Product NDC
23155-133
11-digit product format
231550133
Labeler code
23155
Product ID
23155-133_ec6854e5-3f41-4b8f-be77-49e3bd19f7c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline
Dosage form
TABLET
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA091605
Marketing category
ANDA
Marketing start
2012-05-01
Substance
DOXYCYCLINE
Active strength
50 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
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
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
ndc (product): 23155-133
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE50 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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1649429Internal RxNorm lookup
1650142Internal RxNorm lookup
1650444Internal RxNorm lookup
1652673Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2bcde264-5f6f-47f6-ae2e-1b7010deacf7Available 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
23155-133-01Doxycycline100 in 1 BOTTLETABLET10018
23155-133-05Doxycycline500 in 1 BOTTLETABLET50018
23155-133-11Doxycycline10 in 1 BLISTER PACKTABLET1018
23155-133-30Doxycycline30 in 1 CARTONTABLET3018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-133-01EA - Each23155-133b34bad0e-583b-416b-adf4-e847edfc22ce12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYCYCLINEACTIVE INGREDIENTN12000U13ODOXYCYCLINE TABLET [HERITAGE PHARMACEUTICALS INC.]11
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE TABLET [HERITAGE PHARMACEUTICALS INC.]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE TABLET [HERITAGE PHARMACEUTICALS INC.]11
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DOXYCYCLINE TABLET [HERITAGE PHARMACEUTICALS INC.]11
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDOXYCYCLINE TABLET [HERITAGE PHARMACEUTICALS INC.]11
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WDOXYCYCLINE TABLET [HERITAGE PHARMACEUTICALS INC.]11
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDOXYCYCLINE TABLET [HERITAGE PHARMACEUTICALS INC.]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE TABLET [HERITAGE PHARMACEUTICALS INC.]11
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEDOXYCYCLINE TABLET [HERITAGE PHARMACEUTICALS INC.]11
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DOXYCYCLINE TABLET [HERITAGE PHARMACEUTICALS INC.]11
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DOXYCYCLINE TABLET [HERITAGE PHARMACEUTICALS INC.]11
TALCINACTIVE INGREDIENT7SEV7J4R1UDOXYCYCLINE TABLET [HERITAGE PHARMACEUTICALS INC.]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE TABLET [HERITAGE PHARMACEUTICALS INC.]11
DOXYCYCLINEACTIVE INGREDIENTN12000U13ODOXYCYCLINE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DOXYCYCLINE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDOXYCYCLINE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WDOXYCYCLINE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDOXYCYCLINE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEDOXYCYCLINE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DOXYCYCLINE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DOXYCYCLINE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDOXYCYCLINE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-133DOXYCYCLINE TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]17Current NDC, Legacy NDC, 4 package rows20241130_2bcde264-5f6f-47f6-ae2e-1b7010deacf7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650142doxycycline monohydrate 100 MG Oral TabletPSN2bcde264-5f6f-47f6-ae2e-1b7010deacf718
1650444doxycycline monohydrate 150 MG Oral TabletPSN2bcde264-5f6f-47f6-ae2e-1b7010deacf718
1652673doxycycline monohydrate 50 MG Oral TabletPSN2bcde264-5f6f-47f6-ae2e-1b7010deacf718
1649429doxycycline monohydrate 75 MG Oral TabletPSN2bcde264-5f6f-47f6-ae2e-1b7010deacf718
1650142doxycycline monohydrate 100 MG Oral TabletSCD2bcde264-5f6f-47f6-ae2e-1b7010deacf718
1650444doxycycline monohydrate 150 MG Oral TabletSCD2bcde264-5f6f-47f6-ae2e-1b7010deacf718
1652673doxycycline monohydrate 50 MG Oral TabletSCD2bcde264-5f6f-47f6-ae2e-1b7010deacf718
1649429doxycycline monohydrate 75 MG Oral TabletSCD2bcde264-5f6f-47f6-ae2e-1b7010deacf718

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-133-0123155013301100 TABLET in 1 BOTTLE (23155-133-01) 100 tablet2012-05-010000-00-00NoNoCurrent
23155-133-0523155013305500 TABLET in 1 BOTTLE (23155-133-05) 500 tablet2012-05-010000-00-00NoNoCurrent
23155-133-112315501331110 TABLET in 1 BLISTER PACK (23155-133-11) 10 tablet2012-05-010000-00-00NoNoCurrent
23155-133-302315501333030 TABLET in 1 CARTON (23155-133-30) 30 tablet2012-05-010000-00-00NoNoCurrent