Doxycycline Hyclate

Product NDC
72162-2256
11-digit product format
721622256
Labeler code
72162
Product ID
72162-2256_c3d3fe43-2edf-485c-8cdc-3ca5970c0693
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA065182
Marketing category
ANDA
Marketing start
2019-08-30
Substance
DOXYCYCLINE HYCLATE
Active strength
20 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 43.

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
A065182-001DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 20MG BASETABLET / ORALAB2005-05-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065182-001AB

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A065182-001DOXYCYCLINE HYCLATEEQ 20MG BASETABLET / ORALAB2005-05-1384e616aacf4f…
2026-08-18 06:07:402026-07A065182-001DOXYCYCLINE HYCLATEEQ 20MG BASETABLET / ORALAB2005-05-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065182-001DOXYCYCLINE HYCLATEEQ 20MG BASETABLET / ORALAB2005-05-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065182-001DOXYCYCLINE HYCLATEEQ 20MG BASETABLET / ORALAB2005-05-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A065182-001DOXYCYCLINE HYCLATEEQ 20MG BASETABLET / ORALAB2005-05-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065182-001DOXYCYCLINE HYCLATEEQ 20MG BASETABLET / ORALAB2005-05-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065182-001DOXYCYCLINE HYCLATEEQ 20MG BASETABLET / ORALAB2005-05-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065182-001DOXYCYCLINE HYCLATEEQ 20MG BASETABLET / ORALAB2005-05-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065182-001DOXYCYCLINE HYCLATEEQ 20MG BASETABLET / ORALAB2005-05-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065182-001DOXYCYCLINE HYCLATEEQ 20MG BASETABLET / ORALAB2005-05-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065182-001DOXYCYCLINE HYCLATEEQ 20MG BASETABLET / ORALAB2005-05-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065182-001DOXYCYCLINE HYCLATEEQ 20MG BASETABLET / ORALAB2005-05-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065182-001DOXYCYCLINE HYCLATEEQ 20MG BASETABLET / ORALAB2005-05-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065182-001DOXYCYCLINE HYCLATEEQ 20MG BASETABLET / ORALAB2005-05-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065182-001DOXYCYCLINE HYCLATEEQ 20MG BASETABLET / ORALAB2005-05-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065182-001DOXYCYCLINE HYCLATEEQ 20MG BASETABLET / ORALAB2005-05-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065182-001DOXYCYCLINE HYCLATEEQ 20MG BASETABLET / ORALAB2005-05-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065182-001DOXYCYCLINE HYCLATEEQ 20MG BASETABLET / ORALAB2005-05-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065182-001DOXYCYCLINE HYCLATEEQ 20MG BASETABLET / ORALAB2005-05-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065182-001DOXYCYCLINE HYCLATEEQ 20MG BASETABLET / ORALAB2005-05-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065182-001DOXYCYCLINE HYCLATEEQ 20MG BASETABLET / ORALAB2005-05-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065182-001DOXYCYCLINE HYCLATEEQ 20MG BASETABLET / ORALAB2005-05-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065182-001DOXYCYCLINE HYCLATEEQ 20MG BASETABLET / ORALAB2005-05-1387673890dc5c…
2021-03-12 10:30 UTC2021-03A065182-001DOXYCYCLINE HYCLATEEQ 20MG BASETABLET / ORALAB2005-05-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065182-001DOXYCYCLINE HYCLATEEQ 20MG BASETABLET / ORALAB2005-05-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065182-001DOXYCYCLINE HYCLATEEQ 20MG BASETABLET / ORALAB2005-05-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065182-001DOXYCYCLINE HYCLATEEQ 20MG BASETABLET / ORALAB2005-05-133f01610625f2…
2019-09-15 20:21 UTC2019-09A065182-001DOXYCYCLINE HYCLATEEQ 20MG BASETABLET / ORALAB2005-05-13b00525d2431f…
2019-07-19 19:46 UTC2019-07A065182-001DOXYCYCLINE HYCLATEEQ 20MG BASETABLET / ORAL2005-05-13ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065182-001DOXYCYCLINE HYCLATEEQ 20MG BASETABLET / ORALAB2005-05-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065182-001DOXYCYCLINE HYCLATEEQ 20MG BASETABLET / ORALAB2005-05-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065182-001DOXYCYCLINE HYCLATEEQ 20MG BASETABLET / ORALAB2005-05-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065182-001DOXYCYCLINE HYCLATEEQ 20MG BASETABLET / ORALAB2005-05-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065182-001DOXYCYCLINE HYCLATEEQ 20MG BASETABLET / ORALAB2005-05-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065182-001DOXYCYCLINE HYCLATEEQ 20MG BASETABLET / ORALAB2005-05-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065182-001DOXYCYCLINE HYCLATEEQ 20MG BASETABLET / ORALAB2005-05-133f0d92c62455…
2023-05-13 08:27 UTC2023-05A065182-001DOXYCYCLINE HYCLATEEQ 20MG BASETABLET / ORALAB2005-05-13053a50430f4f…
2023-01-26 05:58 UTC2023-01A065182-001DOXYCYCLINE HYCLATEEQ 20MG BASETABLET / ORALAB2005-05-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065182-001DOXYCYCLINE HYCLATEEQ 20MG BASETABLET / ORALAB2005-05-133a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065182-001DOXYCYCLINE HYCLATEEQ 20MG BASETABLET / ORALAB2005-05-13f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A065182-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A065182-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065182-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065182-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065182-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065182-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065182-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065182-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065182-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065182-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065182-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065182-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065182-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065182-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065182-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065182-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065182-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065182-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065182-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065182-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065182-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065182-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065182-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A065182-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065182-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065182-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065182-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A065182-001AB1b00525d2431f…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065182-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065182-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065182-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065182-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065182-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065182-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065182-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A065182-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A065182-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065182-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065182-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065182-001AB1e64feba35796…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE HYCLATE20 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
283535Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
861b71f3-37e8-4596-838c-c8dad8ed5ff4Available 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
72162-2256-1Doxycycline Hyclate100 in 1 BOTTLETABLET100101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2256-1EA - Each72162-2256dd487dd7-52e8-464f-ac22-008e7ed2b49b12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2256DOXYCYCLINE HYCLATE TABLET [BRYANT RANCH PREPACK]101Current NDC, 1 package rows20250309_861b71f3-37e8-4596-838c-c8dad8ed5ff4.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doxycycline HyclateDOXYCYCLINE HYCLATEEPIC PHARMA, LLCb3cd7b44-db40-4ce5-895e-d4c85a0068ae2025-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065182
application number: ANDA065182
Doxycycline HyclateDOXYCYCLINE HYCLATEBryant Ranch Prepack861b71f3-37e8-4596-838c-c8dad8ed5ff42025-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065182
application number: ANDA065182
ndc (product): 72162-2256
Doxycycline HyclateDOXYCYCLINE HYCLATEBryant Ranch Prepack942ab6dd-e355-41da-b139-72cc8b7a26672025-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065182
application number: ANDA065182

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283535doxycycline hyclate 20 MG Oral TabletPSN861b71f3-37e8-4596-838c-c8dad8ed5ff4101
283535doxycycline hyclate 20 MG Oral TabletSCD861b71f3-37e8-4596-838c-c8dad8ed5ff4101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2256-172162225601100 TABLET in 1 BOTTLE (72162-2256-1) 100 tablet2019-08-30NoNoCurrent