Doxycycline Hyclate

Product NDC
71335-2113
11-digit product format
713352113
Labeler code
71335
Product ID
71335-2113_2a8fc1ec-e0ab-4418-ac20-93d68fa4a5fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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
5b4390ed-a0ec-4ef8-864c-8a33a83653f9Available 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
71335-2113-1Doxycycline Hyclate20 in 1 BOTTLETABLET20104
71335-2113-2Doxycycline Hyclate30 in 1 BOTTLETABLET30104
71335-2113-3Doxycycline Hyclate50 in 1 BOTTLETABLET50104
71335-2113-4Doxycycline Hyclate14 in 1 BOTTLETABLET14104
71335-2113-5Doxycycline Hyclate40 in 1 BOTTLETABLET40104
71335-2113-6Doxycycline Hyclate60 in 1 BOTTLETABLET60104
71335-2113-7Doxycycline Hyclate28 in 1 BOTTLETABLET28104
71335-2113-8Doxycycline Hyclate10 in 1 BOTTLETABLET10104
71335-2113-9Doxycycline Hyclate6 in 1 BOTTLETABLET6104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2113DOXYCYCLINE HYCLATE TABLET [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 9 package rows20250226_5b4390ed-a0ec-4ef8-864c-8a33a83653f9.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
Doxycycline HyclateDOXYCYCLINE HYCLATEBryant Ranch Prepack5b4390ed-a0ec-4ef8-864c-8a33a83653f92025-01-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207773
application number: ANDA207773
ndc (product): 71335-2113
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-2113-17133521130120 TABLET in 1 BOTTLE (71335-2113-1) 20 tablet2025-01-310000-00-00NoNoCurrent
71335-2113-27133521130230 TABLET in 1 BOTTLE (71335-2113-2) 30 tablet2022-09-070000-00-00NoNoCurrent
71335-2113-37133521130350 TABLET in 1 BOTTLE (71335-2113-3) 50 tablet2022-09-070000-00-00NoNoCurrent
71335-2113-47133521130414 TABLET in 1 BOTTLE (71335-2113-4) 14 tablet2025-01-310000-00-00NoNoCurrent
71335-2113-57133521130540 TABLET in 1 BOTTLE (71335-2113-5) 40 tablet2025-01-310000-00-00NoNoCurrent
71335-2113-67133521130660 TABLET in 1 BOTTLE (71335-2113-6) 60 tablet2025-01-31NoNoCurrent
71335-2113-77133521130728 TABLET in 1 BOTTLE (71335-2113-7) 28 tablet2025-01-31NoNoCurrent
71335-2113-87133521130810 TABLET in 1 BOTTLE (71335-2113-8) 10 tablet2025-01-31NoNoCurrent
71335-2113-9713352113096 TABLET in 1 BOTTLE (71335-2113-9) 6 tablet2025-01-31NoNoCurrent