Doxycycline

Product NDC
72189-006
11-digit product format
721890006
Labeler code
72189
Product ID
72189-006_2c4e8635-a2d2-601d-e063-6294a90aaee3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA062396
Marketing category
ANDA
Marketing start
2019-06-25
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
A062396-001DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABRS1984-05-07
A062396-002DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A062396-001AB
A062396-002AB

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 · 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 UTC2026-02A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABRS1984-05-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABRS1984-05-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABRS1984-05-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABRS1984-05-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-078072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-075c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-075d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-074b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-0774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-07bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-07782e0a99824c…
2021-12-28 21:50 UTC2021-12A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-07782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A062396-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062396-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062396-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062396-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A062396-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062396-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062396-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062396-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062396-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062396-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062396-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062396-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062396-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062396-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062396-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062396-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062396-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062396-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062396-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A062396-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062396-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062396-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062396-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062396-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062396-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062396-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062396-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062396-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062396-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062396-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062396-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062396-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062396-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062396-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062396-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A062396-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062396-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A062396-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062396-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A062396-002AB1782e0a99824c…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doxycyclate HyclateDOXYCYCLINE HYCLATEREMEDYREPACK INC.4dc319c1-b7ef-40e4-9e66-fb24cfdefea82026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATEUnit Dose Solutions, Inc.548d4218-2feb-8716-e063-6394a90afbe32026-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.e24a3292-0d4f-4692-8cf7-a82bd19e59322026-06-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.5f523294-e62b-4da5-8799-047d4bed966f2026-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATECoupler LLC52ba329a-8cb3-cf30-e063-6394a90aa0dc2026-05-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATEREMEDYREPACK INC.3a85933f-bd73-4ad7-968d-c90cb7c7a60c2026-05-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATENorthwind Health Company, LLCf309ccbb-b68a-3190-e053-2995a90a0ad42026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATEMajor Pharmaceuticalsc4aae81f-0219-450f-aa60-953964f741722025-12-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATENuCare Pharmaceuticals,Inc.8c525e4e-6e1b-4579-e053-2a95a90a43da2025-11-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATEAmerican Health Packaginge98d11b0-535f-4e57-9639-6358835c04bc2025-11-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATEHikma Pharmaceuticals USA Inc.4ec4c8ca-ce83-4948-8626-21eb82ae5c192025-10-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATECoupler LLC325d5331-d48e-1bc4-e063-6394a90a65b92025-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
DoxycyclineDOXYCYCLINEDirect_Rx8c273efa-62ec-16b2-e053-2995a90ac41d2025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
ndc (product): 72189-006
Doxycycline HyclateDOXYCYCLINE HYCLATEBryant Ranch Prepack214e5a5c-7f3e-478b-93d3-1713de9e76722024-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATENuCare Pharmaceuticals,Inc.88012cf8-509b-84cf-e053-2a95a90af3bc2024-06-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396

Additional Listing Data#

Finished product
Yes
Brand name base
Doxycycline
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
1649988Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8c273efa-62ec-16b2-e053-2995a90ac41dAvailable 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
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
6a5b4392-5ab0-af0d-e0be-47b34e9dbb84Product name520171121
01a4aa74-7e05-63bd-bc10-1b5ceb111371Product name220171115
58b1278c-6dce-49b6-a05e-ea16f389acbaProduct name120160620
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-006-20Doxycycline20 in 1 BOTTLECAPSULE204
72189-006-30Doxycycline30 in 1 BOTTLECAPSULE304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-006-20EA - Each72189-00657341aca-6a88-4403-89cd-f398d76b16a612019-08-06
72189-006-30EA - Each72189-0060bc4ca35-e09e-4a8c-8612-8dd91f0e587512021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-006DOXYCYCLINE CAPSULE [DIRECT_RX]4Current NDC, Legacy NDC, 2 package rows20250123_8c273efa-62ec-16b2-e053-2995a90ac41d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSN8c273efa-62ec-16b2-e053-2995a90ac41d4
1649988doxycycline hyclate 100 MG Oral CapsuleSCD8c273efa-62ec-16b2-e053-2995a90ac41d4
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY8c273efa-62ec-16b2-e053-2995a90ac41d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-006-207218900062020 CAPSULE in 1 BOTTLE (72189-006-20) 20 capsule2019-06-250000-00-00NoNoCurrent
72189-006-307218900063030 CAPSULE in 1 BOTTLE (72189-006-30) 30 capsule2019-06-250000-00-00NoNoCurrent