DOXYCYCLINE HYCLATE

Product NDC
61919-907
11-digit product format
619190907
Labeler code
61919
Product ID
61919-907_8ee7e6ee-16a0-53cc-e053-2995a90ae1dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOXYCYCLINE HYCLATE
Dosage form
CAPSULE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA062500
Marketing category
ANDA
Marketing start
2017-11-01
Marketing end
0000-00-00
Substance
DOXYCYCLINE HYCLATE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61919-907DDiscontinued by firm2026-08-03
excluded packagepackage61919-90761919-907-20DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61919-907-20d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-907-20f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-907-202ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-907-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-907-20cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-907-20cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-907-20302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-907-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-907-200efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61919-907-20ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61919-907-20367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61919-907-20557ba5c1ecfa…9c80585c8c6e…

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
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 · 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 UTC2026-02A062500-001DOXYCYCLINE 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…
2022-03-09 01:35 UTC2022-03A062500-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-09-11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A062500-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-09-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062500-001DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-09-11782e0a99824c…
2021-12-28 21:50 UTC2021-12A062500-002DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-09-11782e0a99824c…

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 UTC2026-02A062500-001AB1011fe1cb6892…
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…
2022-03-09 01:35 UTC2022-03A062500-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A062500-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062500-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A062500-002AB1782e0a99824c…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-907-20EA - Each61919-9078baeb176-fc5f-4378-a2a4-3855ea44158612019-10-07

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-d7a0afca482a2026-07-09Warnings, 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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-907-206191909072020 CAPSULE in 1 BOTTLE (61919-907-20) 20 capsule2017-11-010000-00-00NoNoCurrent