Doxycycline Hyclate

Product NDC
71335-1686
11-digit product format
713351686
Labeler code
71335
Product ID
71335-1686_b6e24c58-c6cb-4722-8824-c879f564b7d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA062505
Marketing category
ANDA
Marketing start
1984-09-11
Substance
DOXYCYCLINE HYCLATE
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A062505-001DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1984-09-11
A062505-002DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB2021-07-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A062505-001AB
A062505-002AB

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.

Product history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A062505-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1984-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062505-002DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB2021-07-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062505-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1984-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062505-002DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB2021-07-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A062505-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1984-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062505-002DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB2021-07-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062505-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1984-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062505-002DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB2021-07-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062505-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1984-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062505-002DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB2021-07-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062505-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1984-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062505-002DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB2021-07-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062505-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1984-09-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062505-002DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB2021-07-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062505-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1984-09-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062505-002DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB2021-07-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062505-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1984-09-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062505-002DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB2021-07-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062505-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1984-09-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A062505-002DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB2021-07-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062505-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1984-09-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062505-002DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB2021-07-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062505-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1984-09-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062505-002DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB2021-07-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062505-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1984-09-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062505-002DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB2021-07-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062505-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1984-09-118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062505-002DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB2021-07-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062505-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1984-09-115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062505-002DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB2021-07-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062505-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1984-09-115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062505-002DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB2021-07-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062505-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1984-09-114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062505-002DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB2021-07-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062505-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1984-09-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062505-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1984-09-11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A062505-002DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB2021-07-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062505-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1984-09-11782e0a99824c…
2021-12-28 21:50 UTC2021-12A062505-002DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB2021-07-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A062505-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1984-09-1187673890dc5c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A062505-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062505-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062505-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062505-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A062505-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062505-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062505-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062505-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062505-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062505-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062505-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062505-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062505-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062505-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062505-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062505-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062505-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062505-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062505-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A062505-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062505-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062505-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062505-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062505-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062505-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062505-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062505-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062505-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062505-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062505-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062505-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062505-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062505-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062505-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062505-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062505-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A062505-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062505-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A062505-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A062505-001AB187673890dc5c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE HYCLATE100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
19XTS3T51UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1650143Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b70a3a12-76a2-4558-bf2c-eaa38a9ba0a0Available 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
71335-1686-1Doxycycline Hyclate20 in 1 BOTTLETABLET, FILM COATED2012
71335-1686-2Doxycycline Hyclate30 in 1 BOTTLETABLET, FILM COATED3012
71335-1686-3Doxycycline Hyclate50 in 1 BOTTLETABLET, FILM COATED5012
71335-1686-4Doxycycline Hyclate14 in 1 BOTTLETABLET, FILM COATED1412
71335-1686-5Doxycycline Hyclate40 in 1 BOTTLETABLET, FILM COATED4012
71335-1686-6Doxycycline Hyclate60 in 1 BOTTLETABLET, FILM COATED6012
71335-1686-7Doxycycline Hyclate28 in 1 BOTTLETABLET, FILM COATED2812
71335-1686-8Doxycycline Hyclate10 in 1 BOTTLETABLET, FILM COATED1012
71335-1686-9Doxycycline Hyclate6 in 1 BOTTLETABLET, FILM COATED612

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1686DOXYCYCLINE HYCLATE TABLET, FILM COATED [BRYANT RANCH PREPACK]11Current NDC, Legacy NDC, 9 package rows20240824_b70a3a12-76a2-4558-bf2c-eaa38a9ba0a0.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doxycycline HyclateDOXYCYCLINE HYCLATEBryant Ranch Prepackb70a3a12-76a2-4558-bf2c-eaa38a9ba0a02026-01-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062505
application number: ANDA062505
ndc (product): 71335-1686
Doxycycline HyclateDOXYCYCLINE HYCLATEGolden State Medical Supply, Inc.98bf51e7-01f8-e3f7-e053-2995a90a42f02025-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062505
application number: ANDA062505
doxycyclineDOXYCYCLINEChartwell Governmental & Specialty RX, LLCb8486639-7eb9-4610-9cd4-0e922045d5922025-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062505
application number: ANDA062505
doxycyclineDOXYCYCLINEChartwell RX LLC3e7cf78f-3b48-4614-9fa4-c6d1e0c05a352025-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062505
application number: ANDA062505
Doxycycline HyclateDOXYCYCLINE HYCLATERedpharm Drug, Inc.09d19663-a8b9-0c3f-e063-6394a90aa4462025-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062505
application number: ANDA062505
DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEdirect rxb56dffde-1334-f5a0-e053-2a95a90a717c2025-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062505
application number: ANDA062505
Doxycycline HyclateDOXYCYCLINE HYCLATENuCare Pharmaceuticals,Inc.a707c9e3-00eb-e832-e053-2a95a90a5f582024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062505
application number: ANDA062505
Doxycycline HyclateDOXYCYCLINE HYCLATEA-S Medication Solutionsa84d7562-08bf-417f-a599-ba0d17c552322024-04-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062505
application number: ANDA062505
Doxycycline HyclateDOXYCYCLINE HYCLATEProficient Rx LPdd7672c9-b10f-4ea1-9000-ef3e3faa10db2022-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062505
application number: ANDA062505

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSNb70a3a12-76a2-4558-bf2c-eaa38a9ba0a012
1650143doxycycline hyclate 100 MG Oral TabletSCDb70a3a12-76a2-4558-bf2c-eaa38a9ba0a012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1686-17133516860120 TABLET, FILM COATED in 1 BOTTLE (71335-1686-1) 2026-01-270000-00-00NoNoCurrent
71335-1686-27133516860230 TABLET, FILM COATED in 1 BOTTLE (71335-1686-2) 2026-01-270000-00-00NoNoCurrent
71335-1686-37133516860350 TABLET, FILM COATED in 1 BOTTLE (71335-1686-3) 2026-01-270000-00-00NoNoCurrent
71335-1686-47133516860414 TABLET, FILM COATED in 1 BOTTLE (71335-1686-4) 2026-01-270000-00-00NoNoCurrent
71335-1686-57133516860540 TABLET, FILM COATED in 1 BOTTLE (71335-1686-5) 2026-01-270000-00-00NoNoCurrent
71335-1686-67133516860660 TABLET, FILM COATED in 1 BOTTLE (71335-1686-6) 2026-01-27NoNoCurrent
71335-1686-77133516860728 TABLET, FILM COATED in 1 BOTTLE (71335-1686-7) 2026-01-27NoNoCurrent
71335-1686-87133516860810 TABLET, FILM COATED in 1 BOTTLE (71335-1686-8) 2026-01-27NoNoCurrent
71335-1686-9713351686096 TABLET, FILM COATED in 1 BOTTLE (71335-1686-9) 2026-01-27NoNoCurrent