Doxycycline Hyclate

Product NDC
63187-845
11-digit product format
631870845
Labeler code
63187
Product ID
63187-845_a9543772-1142-4aa5-a386-e1e77251b16e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOXYCYCLINE HYCLATE
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA062500
Marketing category
ANDA
Marketing start
1984-09-11
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63187-845DDiscontinued by firm2026-08-10
excluded packagepackage63187-84563187-845-14DDiscontinued by firm2026-08-10
excluded packagepackage63187-84563187-845-20DDiscontinued by firm2026-08-10
excluded packagepackage63187-84563187-845-30DDiscontinued by firm2026-08-10

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 · 8 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 packagepackage63187-845-14d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63187-845-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63187-845-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-845-14f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-845-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-845-30f5e01cc5f278…a2eaf40c39c3…

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
63187-845-20EA - Each63187-8458944f794-82bf-4b3c-b77b-01b8a9efcc1f12017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-845DOXYCYCLINE HYCLATE CAPSULE [PROFICIENT RX LP]3Legacy NDC20191113_de5dd8b7-ce8c-4af5-84dc-fa922e87059e.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-d7a0afca482a2026-07-09Warnings, 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
63187-845-146318708451414 CAPSULE in 1 BOTTLE (63187-845-14) 14 capsule2017-05-010000-00-00NoNoCurrent
63187-845-206318708452020 CAPSULE in 1 BOTTLE (63187-845-20) 20 capsule2017-05-010000-00-00NoNoCurrent
63187-845-306318708453030 CAPSULE in 1 BOTTLE (63187-845-30) 30 capsule2017-05-010000-00-00NoNoCurrent