Doxycycline hyclate

Product NDC
72578-054
11-digit product format
725780054
Labeler code
72578
Product ID
72578-054_ebe90bc1-d956-4813-9d89-16212c08966b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline hyclate
Dosage form
CAPSULE
Route
ORAL
Labeler
Viona Pharmaceuticals Inc
Application
ANDA207774
Marketing category
ANDA
Marketing start
2022-01-10
Substance
DOXYCYCLINE HYCLATE
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 · 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 HYCLATE50 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1649405Internal RxNorm lookup
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
51d245a3-ef51-474a-bc91-377d5f42dde3Available 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
72578-054-01Doxycycline hyclate100 in 1 BOTTLECAPSULE1006
72578-054-05Doxycycline hyclate500 in 1 BOTTLECAPSULE5006
72578-054-10Doxycycline hyclate1000 in 1 BOTTLECAPSULE10006
72578-054-18Doxycycline hyclate50 in 1 BOTTLECAPSULE506
72578-054-30Doxycycline hyclate10 in 1 BLISTER PACKCAPSULE106
72578-054-77Doxycycline hyclate10 in 1 CARTONCAPSULE106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72578-054-18EA - Each72578-05417c142e2-3f88-48e2-b7ea-c539d1ce234512022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72578-054DOXYCYCLINE HYCLATE CAPSULE [VIONA PHARMACEUTICALS INC]4Current NDC, Legacy NDC, 6 package rows20250529_51d245a3-ef51-474a-bc91-377d5f42dde3.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
ndc (product): 72578-054
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
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
1649405doxycycline hyclate 50 MG Oral CapsulePSNb612d2f5-b703-47f0-b5eb-b66a7aeed577102
1649405doxycycline hyclate 50 MG Oral CapsuleSCDb612d2f5-b703-47f0-b5eb-b66a7aeed577102
1649405doxycycline hyclate 50 MG Oral CapsulePSNbea36ec9-f7fd-4295-bfbd-0228cffcddd77
1649405doxycycline hyclate 50 MG Oral CapsuleSCDbea36ec9-f7fd-4295-bfbd-0228cffcddd77
1649988doxycycline hyclate 100 MG Oral CapsulePSN51d245a3-ef51-474a-bc91-377d5f42dde36
1649405doxycycline hyclate 50 MG Oral CapsulePSN51d245a3-ef51-474a-bc91-377d5f42dde36
1649988doxycycline hyclate 100 MG Oral CapsuleSCD51d245a3-ef51-474a-bc91-377d5f42dde36
1649405doxycycline hyclate 50 MG Oral CapsuleSCD51d245a3-ef51-474a-bc91-377d5f42dde36
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY51d245a3-ef51-474a-bc91-377d5f42dde36
1649988doxycycline hyclate 100 MG Oral CapsulePSNbed39bae-64c2-44b4-9c95-682ead4e67384
1649405doxycycline hyclate 50 MG Oral CapsulePSNbed39bae-64c2-44b4-9c95-682ead4e67384
1649988doxycycline hyclate 100 MG Oral CapsuleSCDbed39bae-64c2-44b4-9c95-682ead4e67384
1649405doxycycline hyclate 50 MG Oral CapsuleSCDbed39bae-64c2-44b4-9c95-682ead4e67384
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYbed39bae-64c2-44b4-9c95-682ead4e67384

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72578-054-0172578005401100 CAPSULE in 1 BOTTLE (72578-054-01) 100 capsule2022-01-100000-00-00NoNoCurrent
72578-054-0572578005405500 CAPSULE in 1 BOTTLE (72578-054-05) 500 capsule2022-01-100000-00-00NoNoCurrent
72578-054-10725780054101000 CAPSULE in 1 BOTTLE (72578-054-10) 1000 capsule2022-01-100000-00-00NoNoCurrent
72578-054-187257800541850 CAPSULE in 1 BOTTLE (72578-054-18) 50 capsule2022-01-100000-00-00NoNoCurrent
72578-054-307257800543010 in 1 BLISTER PACKHistorical
72578-054-777257800547710 BLISTER PACK in 1 CARTON (72578-054-77) / 10 CAPSULE in 1 BLISTER PACK (72578-054-30) 10 blister pack2022-01-100000-00-00NoNoCurrent