Doxycycline Hyclate

Product NDC
83112-985
Requested package NDC
83112-985-42
11-digit product format
831120985
Labeler code
83112
Product ID
83112-985_47479ed6-5616-c375-e063-6294a90afef4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
CAPSULE
Route
ORAL
Labeler
Health Department, Oklahoma State
Application
ANDA062500
Marketing category
ANDA
Marketing start
1984-09-11
Substance
DOXYCYCLINE HYCLATE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A062500-001DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-09-11
A062500-002DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-09-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A062500-001AB
A062500-002AB

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A062500-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-09-1184e616aacf4f…
2026-09-14 22:38:342026-08A062500-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-09-1184e616aacf4f…
2026-08-18 06:07:402026-07A062500-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A062500-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-09-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A062500-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062500-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-09-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062500-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062500-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-09-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A062500-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062500-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-09-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062500-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062500-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-09-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062500-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062500-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-09-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062500-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062500-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-09-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062500-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-09-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062500-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-09-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062500-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-09-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062500-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-09-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062500-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-09-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062500-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-09-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062500-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-09-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A062500-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-09-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062500-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-09-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062500-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-09-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062500-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-09-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062500-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-09-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062500-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-09-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062500-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-09-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062500-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-09-118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062500-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-09-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062500-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-09-115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062500-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-09-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062500-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-09-115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062500-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-09-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062500-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-09-114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062500-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-09-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062500-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-09-1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A062500-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-09-1174a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A062500-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A062500-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A062500-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A062500-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A062500-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062500-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062500-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062500-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A062500-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062500-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062500-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062500-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062500-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062500-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062500-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062500-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062500-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062500-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062500-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062500-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062500-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062500-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062500-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A062500-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062500-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062500-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062500-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062500-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062500-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062500-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062500-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062500-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062500-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062500-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062500-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062500-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062500-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062500-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062500-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A062500-002AB174a2ff9319b5…

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
2027-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1649988Internal RxNorm lookup
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
f39365f9-eb64-00cb-e053-2995a90a8d80Available 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
83112-985-14Doxycycline Hyclate14 in 1 PACKAGECAPSULE144
83112-985-28Doxycycline Hyclate28 in 1 PACKAGECAPSULE284
83112-985-42Doxycycline Hyclate42 in 1 PACKAGECAPSULE424

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83112-985DOXYCYCLINE CAPSULE DOXYCYCLINE HYCLATE CAPSULE [HEALTH DEPARTMENT, OKLAHOMA STATE]3Current NDC, 3 package rows20250101_f39365f9-eb64-00cb-e053-2995a90a8d80.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 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
doxycycline hyclateDOXYCYCLINE HYCLATEHAWAII REPACK, INC88c429a1-351d-432e-b69b-d7a0afca482a2026-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062500
application number: ANDA062500
doxycycline hyclateDOXYCYCLINE HYCLATEBryant Ranch Prepack0aaa4ff7-7fba-4a40-9b49-82e4da68a48f2026-03-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062500
application number: ANDA062500
doxycycline hyclateDOXYCYCLINE HYCLATESportpharm LLC50617adc-8528-414d-bb6c-78887d4049832026-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062500
application number: ANDA062500
doxycycline hyclateDOXYCYCLINE HYCLATEBryant Ranch Prepack6e06e73c-b777-4a2d-988f-b009f2fc34d12026-01-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062500
application number: ANDA062500
doxycycline hyclateDOXYCYCLINE HYCLATEBryant Ranch Prepack6f530f28-8c10-41dc-818f-1aef2306bde52026-01-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062500
application number: ANDA062500
Doxycycline HyclateDOXYCYCLINE HYCLATEHealth Department, Oklahoma Statef39365f9-eb64-00cb-e053-2995a90a8d802025-12-31WarningsExact identifier
application applno (ANDA): 062500
application number: ANDA062500
ndc (package): 83112-985-42
ndc (product): 83112-985
ndc11 (package): 83112098542
doxycycline hyclateDOXYCYCLINE HYCLATEBryant Ranch Prepack6624a43a-28ff-4d55-b5dd-1e805bfa87782025-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062500
application number: ANDA062500
doxycyclineDOXYCYCLINEChartwell Governmental & Specialty RX, LLCb8486639-7eb9-4610-9cd4-0e922045d5922025-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062500
application number: ANDA062500
doxycyclineDOXYCYCLINEChartwell RX LLC3e7cf78f-3b48-4614-9fa4-c6d1e0c05a352025-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062500
application number: ANDA062500
Doxycycline HyclateDOXYCYCLINE HYCLATEAsclemed USA, Inc.a5571acf-3284-4559-8cc0-b4856ac6d94d2025-05-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062500
application number: ANDA062500
Doxycycline HyclateDOXYCYCLINE HYCLATENuCare Pharmaceuticals,Inc.a5f02688-cbba-4d9b-e053-2995a90ad1ba2024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062500
application number: ANDA062500
Doxycycline HyclateDOXYCYCLINE HYCLATENuCare Pharmaceuticals,Inc.a2161675-505c-3d65-e053-2995a90aa6442024-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062500
application number: ANDA062500
doxycycline hyclateDOXYCYCLINE HYCLATEA-S Medication Solutionsa2df1a8c-7a22-462d-830a-04e6ac5a912f2024-04-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062500
application number: ANDA062500
doxycycline hyclateDOXYCYCLINE HYCLATEA-S Medication Solutions1dd7a94e-bf29-4f07-9476-ac8d1f9ab5652024-04-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062500
application number: ANDA062500
doxycycline hyclateDOXYCYCLINE HYCLATEA-S Medication Solutions4164f6b7-5ebd-4f5f-a536-9a37b2e0562c2024-04-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062500
application number: ANDA062500
doxycycline hyclateDOXYCYCLINE HYCLATEProficient Rx LP2993ac3d-0ec4-4230-858e-9fd00063cf572022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062500
application number: ANDA062500
doxycycline hyclateDOXYCYCLINE HYCLATEProficient Rx LP3303b423-b270-495b-9360-e43144fcf6f22021-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062500
application number: ANDA062500

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSNf39365f9-eb64-00cb-e053-2995a90a8d804
1650143doxycycline hyclate 100 MG Oral TabletPSNf39365f9-eb64-00cb-e053-2995a90a8d804
1649988doxycycline hyclate 100 MG Oral CapsuleSCDf39365f9-eb64-00cb-e053-2995a90a8d804
1650143doxycycline hyclate 100 MG Oral TabletSCDf39365f9-eb64-00cb-e053-2995a90a8d804
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYf39365f9-eb64-00cb-e053-2995a90a8d804

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83112-985-428311209854242 CAPSULE in 1 PACKAGE (83112-985-42) 42 capsule1984-09-11NoNoCurrent