Doxycycline Hyclate

Product NDC
72578-001
11-digit product format
725780001
Labeler code
72578
Product ID
72578-001_6fd4ce71-429d-4bbb-a8e6-afd510319830
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
TABLET
Route
ORAL
Labeler
Viona Pharmaceuticals Inc
Application
ANDA207773
Marketing category
ANDA
Marketing start
2019-03-14
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207773-001DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207773-001AB

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-303f01610625f2…
2019-09-15 20:21 UTC2019-09A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207773-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2017-10-30cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A207773-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207773-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207773-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207773-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207773-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207773-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207773-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207773-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207773-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207773-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207773-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207773-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207773-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207773-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207773-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207773-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207773-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207773-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207773-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207773-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207773-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A207773-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207773-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207773-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207773-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A207773-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A207773-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207773-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207773-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207773-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207773-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207773-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207773-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207773-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A207773-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A207773-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207773-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207773-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207773-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207773-001AB1cb3db0bc1861…

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
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
763997f0-b35c-43cb-a792-3e0bae589536Available 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
72578-001-01Doxycycline Hyclate100 in 1 BOTTLETABLET1007
72578-001-05Doxycycline Hyclate500 in 1 BOTTLETABLET5007
72578-001-10Doxycycline Hyclate1000 in 1 BOTTLETABLET10007
72578-001-18Doxycycline Hyclate50 in 1 BOTTLETABLET507
72578-001-30Doxycycline Hyclate10 in 1 BLISTER PACKTABLET107
72578-001-77Doxycycline Hyclate10 in 1 CARTONTABLET107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72578-001-05EA - Each72578-00189f63c6c-7909-49e8-bbb1-f9aa442f2bf412019-09-05
72578-001-18EA - Each72578-00112d4a54d-0719-4b25-9438-6b7b48b835e612019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72578-001DOXYCYCLINE HYCLATE TABLET [VIONA PHARMACEUTICALS INC]6Current NDC, Legacy NDC, 6 package rows20250429_763997f0-b35c-43cb-a792-3e0bae589536.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doxycycline HyclateDOXYCYCLINE HYCLATERedPharm Drug, Inc.bdacaaa7-b46e-ee0c-e053-2a95a90aea3c2026-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207773
application number: ANDA207773
Doxycycline HyclateDOXYCYCLINE HYCLATEViona Pharmaceuticals Inc763997f0-b35c-43cb-a792-3e0bae5895362025-08-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207773
application number: ANDA207773
ndc (product): 72578-001
Doxycycline HyclateDOXYCYCLINE HYCLATEBryant Ranch Prepack5b4390ed-a0ec-4ef8-864c-8a33a83653f92025-01-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207773
application number: ANDA207773
Doxycycline HyclateDOXYCYCLINE HYCLATENCS HealthCare of KY, LLC dba Vangard Labs104cac0f-7c99-4faf-ba08-0159ed767a3e2024-10-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207773
application number: ANDA207773
Doxycycline hyclateDOXYCYCLINE HYCLATEZydus Lifesciences Limited68b3aba5-f1e4-4cdf-b244-0302aa8595fe2024-08-16Exact identifier
application applno (ANDA): 207773
application number: ANDA207773

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSN5b4390ed-a0ec-4ef8-864c-8a33a83653f9104
1650143doxycycline hyclate 100 MG Oral TabletSCD5b4390ed-a0ec-4ef8-864c-8a33a83653f9104
1650143doxycycline hyclate 100 MG Oral TabletPSN763997f0-b35c-43cb-a792-3e0bae5895367
1650143doxycycline hyclate 100 MG Oral TabletSCD763997f0-b35c-43cb-a792-3e0bae5895367
1650143doxycycline hyclate 100 MG Oral TabletPSNbdacaaa7-b46e-ee0c-e053-2a95a90aea3c3
1650143doxycycline hyclate 100 MG Oral TabletSCDbdacaaa7-b46e-ee0c-e053-2a95a90aea3c3
1650143doxycycline hyclate 100 MG Oral TabletPSN104cac0f-7c99-4faf-ba08-0159ed767a3e1
1650143doxycycline hyclate 100 MG Oral TabletSCD104cac0f-7c99-4faf-ba08-0159ed767a3e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72578-001-0172578000101100 TABLET in 1 BOTTLE (72578-001-01) 100 tablet2019-03-140000-00-00NoNoCurrent
72578-001-0572578000105500 TABLET in 1 BOTTLE (72578-001-05) 500 tablet2019-03-140000-00-00NoNoCurrent
72578-001-10725780001101000 TABLET in 1 BOTTLE (72578-001-10) 1000 tablet2019-03-140000-00-00NoNoCurrent
72578-001-187257800011850 TABLET in 1 BOTTLE (72578-001-18) 50 tablet2019-03-140000-00-00NoNoCurrent
72578-001-307257800013010 in 1 BLISTER PACKHistorical
72578-001-777257800017710 BLISTER PACK in 1 CARTON (72578-001-77) / 10 TABLET in 1 BLISTER PACK (72578-001-30) 10 blister pack2019-03-140000-00-00NoNoCurrent