Doxycycline Hyclate

Product NDC
68071-4836
11-digit product format
680714836
Labeler code
68071
Product ID
68071-4836_1ae175c6-5f09-8a7a-e063-6294a90a6461
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA062269
Marketing category
ANDA
Marketing start
2016-10-01
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
A062269-002DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-08
A062269-003DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A062269-002AB
A062269-003AB

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 UTC2026-02A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-088072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-085c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-085d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-084b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1982-11-0874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORAL1983-10-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-08bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-08782e0a99824c…
2021-12-28 21:50 UTC2021-12A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-05782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A062269-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062269-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062269-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062269-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A062269-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062269-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062269-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062269-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062269-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062269-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062269-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062269-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062269-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062269-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062269-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062269-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062269-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062269-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062269-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A062269-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062269-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062269-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062269-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062269-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062269-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062269-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062269-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062269-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062269-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062269-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062269-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062269-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062269-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062269-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062269-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062269-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A062269-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062269-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A062269-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A062269-002AB187673890dc5c…

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
860a1566-5857-ed88-e053-2991aa0ae2a4Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4836-82021-02-17C16284748780-1ba0f9c33-1b53-a910-e053-dadaa90a0b85Doxycycline Hyclate Tablets, USP 100 mg
68071-4836-82021-01-29C16284748780-1ba0f9c33-1b53-a910-e053-dadaa90a0b85Doxycycline Hyclate Tablets, USP 100 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4836-1Doxycycline Hyclate10 in 1 BOTTLETABLET, FILM COATED105
68071-4836-7Doxycycline Hyclate14 in 1 BOTTLETABLET, FILM COATED145
68071-4836-8Doxycycline Hyclate28 in 1 BOTTLETABLET, FILM COATED285

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4836DOXYCYCLINE HYCLATE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 3 package rows20240616_860a1566-5857-ed88-e053-2991aa0ae2a4.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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doxycycline HyclateDOXYCYCLINE HYCLATEREMEDYREPACK INC.2305ab4a-7d08-41f6-9c39-c9b6835be3892026-04-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062269
application number: ANDA062269
Doxycycline HyclateDOXYCYCLINE HYCLATEHealth Department, Oklahoma Statef39365f9-eb64-00cb-e053-2995a90a8d802025-12-31WarningsExact identifier
application applno (ANDA): 062269
application number: ANDA062269
Doxycycline HyclateDOXYCYCLINE HYCLATERedpharm Drug44f2fdde-cf84-6f42-e063-6394a90af94e2025-12-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062269
application number: ANDA062269
Doxycycline HyclateDOXYCYCLINE HYCLATEA-S Medication Solutionsca63aa91-519d-429f-adfc-a4ec453672942025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062269
application number: ANDA062269
Doxycycline HyclateDOXYCYCLINE HYCLATEREMEDYREPACK INC.051654c7-8ba6-44f2-842c-72f515e9b32d2025-10-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062269
application number: ANDA062269
TARGADOXDOXYCYCLINE HYCLATEJourney Medical Corporation83243f78-b984-46a4-a88a-c6a15c217b902025-10-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062269
application number: ANDA062269
Doxycycline HyclateDOXYCYCLINE HYCLATEJG Pharma Inc.10b8bf71-4311-41e8-a891-bab8bc86863f2025-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062269
application number: ANDA062269
Doxycycline HyclateDOXYCYCLINE HYCLATEA-S Medication Solutions61195fc6-3fa7-4203-b526-477b483958562025-05-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062269
application number: ANDA062269
Doxycycline HyclateDOXYCYCLINE HYCLATEA-S Medication Solutions9cbd8699-e2c2-40d4-8797-e676f2a10eb22025-05-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062269
application number: ANDA062269
Doxycycline HyclateDOXYCYCLINE HYCLATEPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS65cac0b6-3550-48cf-bffa-cf42443c27312025-04-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062269
application number: ANDA062269
Doxycycline HyclateDOXYCYCLINE HYCLATEEpic Pharma, LLC2b402587-8ecc-4fea-83ad-8071345b63562025-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062269
application number: ANDA062269
Doxycycline HyclateDOXYCYCLINE HYCLATENuCare Pharmaceuticals,Inc.860a1566-5857-ed88-e053-2991aa0ae2a42024-06-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062269
application number: ANDA062269
ndc (product): 68071-4836

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSN860a1566-5857-ed88-e053-2991aa0ae2a45
1650143doxycycline hyclate 100 MG Oral TabletSCD860a1566-5857-ed88-e053-2991aa0ae2a45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-4836-16807148360110 TABLET, FILM COATED in 1 BOTTLE (68071-4836-1) 2019-04-08NoNoCurrent
68071-4836-76807148360714 TABLET, FILM COATED in 1 BOTTLE (68071-4836-7) 2019-04-080000-00-00NoNoCurrent
68071-4836-86807148360828 TABLET, FILM COATED in 1 BOTTLE (68071-4836-8) 2019-04-080000-00-00NoNoCurrent