Doxycycline hyclate

Product NDC
71335-2086
11-digit product format
713352086
Labeler code
71335
Product ID
71335-2086_19a9909b-de48-4cb9-8b34-45b6a1b0dade
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline hyclate
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207774
Marketing category
ANDA
Marketing start
2022-01-10
Substance
DOXYCYCLINE HYCLATE
Active strength
100 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207774-001DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB2018-05-31
A207774-002DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2018-05-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207774-001AB
A207774-002AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A207774-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB2018-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207774-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2018-05-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207774-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB2018-05-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207774-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2018-05-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207774-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB2018-05-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207774-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2018-05-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207774-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB2018-05-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207774-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2018-05-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207774-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB2018-05-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207774-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2018-05-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207774-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB2018-05-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207774-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2018-05-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207774-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB2018-05-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207774-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2018-05-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207774-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB2018-05-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207774-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2018-05-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207774-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB2018-05-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207774-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2018-05-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207774-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB2018-05-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A207774-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2018-05-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207774-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB2018-05-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207774-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2018-05-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207774-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB2018-05-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207774-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2018-05-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207774-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB2018-05-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207774-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2018-05-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207774-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB2018-05-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207774-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2018-05-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207774-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB2018-05-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207774-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2018-05-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207774-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB2018-05-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207774-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2018-05-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207774-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB2018-05-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207774-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2018-05-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207774-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB2018-05-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207774-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2018-05-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207774-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB2018-05-31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207774-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2018-05-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207774-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB2018-05-31782e0a99824c…
2021-12-28 21:50 UTC2021-12A207774-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2018-05-31782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A207774-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207774-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207774-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207774-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207774-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207774-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207774-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207774-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207774-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207774-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207774-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207774-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207774-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207774-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207774-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207774-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207774-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207774-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207774-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207774-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207774-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207774-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207774-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207774-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207774-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207774-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207774-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207774-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207774-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207774-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207774-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207774-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207774-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207774-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207774-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207774-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207774-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207774-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207774-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A207774-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Doxycycline hyclate
Listing expiration
2026-12-31

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
1649988Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
30b041a0-8f5f-4d9f-b11b-106f7432955bAvailable 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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
71335-2086-0Doxycycline hyclate6 in 1 BOTTLECAPSULE6103
71335-2086-1Doxycycline hyclate10 in 1 BOTTLECAPSULE10103
71335-2086-2Doxycycline hyclate20 in 1 BOTTLECAPSULE20103
71335-2086-3Doxycycline hyclate30 in 1 BOTTLECAPSULE30103
71335-2086-4Doxycycline hyclate40 in 1 BOTTLECAPSULE40103
71335-2086-5Doxycycline hyclate60 in 1 BOTTLECAPSULE60103
71335-2086-6Doxycycline hyclate28 in 1 BOTTLECAPSULE28103
71335-2086-7Doxycycline hyclate14 in 1 BOTTLECAPSULE14103
71335-2086-8Doxycycline hyclate90 in 1 BOTTLECAPSULE90103
71335-2086-9Doxycycline hyclate365 in 1 BOTTLECAPSULE365103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2086-1EA - Each71335-20860930c4b7-2e25-464b-ad42-754c9ba0ce4812024-02-14
71335-2086-2EA - Each71335-2086d9cc2eec-b3b7-4df6-b481-5a8980c8b09212024-02-14
71335-2086-3EA - Each71335-2086cae2aaa4-e18c-4b6f-80f5-0e431c0c6f5512024-02-14
71335-2086-5EA - Each71335-2086659e852f-0eb1-447e-9598-24ac8dcfc8a712024-02-14
71335-2086-7EA - Each71335-2086d0fd83dc-d399-4111-8851-f2cd3d8ee70312024-02-14
71335-2086-8EA - Each71335-2086ed80c7d4-7e5a-42ef-878d-6fd70ef8520812024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2086DOXYCYCLINE HYCLATE CAPSULE [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 10 package rows20240824_30b041a0-8f5f-4d9f-b11b-106f7432955b.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 HYCLATEA-S Medication Solutionsbea36ec9-f7fd-4295-bfbd-0228cffcddd72026-02-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207774
application number: ANDA207774
Doxycycline hyclateDOXYCYCLINE HYCLATESportpharm LLC45c4b584-b7e2-4e91-a93d-aff14feb606f2026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207774
application number: ANDA207774
Doxycycline hyclateDOXYCYCLINE HYCLATEREMEDYREPACK INC.df44c686-de34-487a-8741-a0a12993cab22026-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207774
application number: ANDA207774
Doxycycline hyclateDOXYCYCLINE HYCLATEViona Pharmaceuticals Inc51d245a3-ef51-474a-bc91-377d5f42dde32025-08-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207774
application number: ANDA207774
Doxycycline hyclateDOXYCYCLINE HYCLATEBryant Ranch Prepackb612d2f5-b703-47f0-b5eb-b66a7aeed5772025-06-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207774
application number: ANDA207774
Doxycycline hyclateDOXYCYCLINE HYCLATEAsclemed USA, Inc.bed39bae-64c2-44b4-9c95-682ead4e67382025-05-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207774
application number: ANDA207774
Doxycycline hyclateDOXYCYCLINE HYCLATEProficient Rx LP65b3a0e2-32a5-436a-b805-854fbffcb6112025-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207774
application number: ANDA207774
Doxycycline hyclateDOXYCYCLINE HYCLATEBryant Ranch Prepack30b041a0-8f5f-4d9f-b11b-106f7432955b2024-08-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207774
application number: ANDA207774
ndc (product): 71335-2086
Doxycycline hyclateDOXYCYCLINE HYCLATEZydus Lifesciences Limitedfc8213e3-e546-495f-ac2c-3856db79c6e12024-08-16Exact identifier
application applno (ANDA): 207774
application number: ANDA207774

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSN30b041a0-8f5f-4d9f-b11b-106f7432955b103
1649988doxycycline hyclate 100 MG Oral CapsuleSCD30b041a0-8f5f-4d9f-b11b-106f7432955b103
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY30b041a0-8f5f-4d9f-b11b-106f7432955b103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-2086-0713352086006 CAPSULE in 1 BOTTLE (71335-2086-0) 6 capsule2024-04-030000-00-00NoNoCurrent
71335-2086-17133520860110 CAPSULE in 1 BOTTLE (71335-2086-1) 10 capsule2022-12-080000-00-00NoNoCurrent
71335-2086-27133520860220 CAPSULE in 1 BOTTLE (71335-2086-2) 20 capsule2022-05-240000-00-00NoNoCurrent
71335-2086-37133520860330 CAPSULE in 1 BOTTLE (71335-2086-3) 30 capsule2022-08-220000-00-00NoNoCurrent
71335-2086-47133520860440 CAPSULE in 1 BOTTLE (71335-2086-4) 40 capsule2024-04-030000-00-00NoNoCurrent
71335-2086-57133520860560 CAPSULE in 1 BOTTLE (71335-2086-5) 60 capsule2022-09-090000-00-00NoNoCurrent
71335-2086-67133520860628 CAPSULE in 1 BOTTLE (71335-2086-6) 28 capsule2024-04-030000-00-00NoNoCurrent
71335-2086-77133520860714 CAPSULE in 1 BOTTLE (71335-2086-7) 14 capsule2022-09-140000-00-00NoNoCurrent
71335-2086-87133520860890 CAPSULE in 1 BOTTLE (71335-2086-8) 90 capsule2022-08-240000-00-00NoNoCurrent
71335-2086-971335208609365 CAPSULE in 1 BOTTLE (71335-2086-9) 365 capsule2024-04-030000-00-00NoNoCurrent