Doxycycline Monohydrate

Product NDC
71610-220
11-digit product format
716100220
Labeler code
71610
Product ID
71610-220_fadba8a4-d8e7-482a-836f-2da4b867eb28
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
NDA050641
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2005-02-07
Marketing end
0000-00-00
Substance
DOXYCYCLINE
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 productproduct71610-220DDiscontinued by firm2026-08-11
excluded packagepackage71610-22071610-220-83DDiscontinued by firm2026-08-11

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 · 4 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 packagepackage71610-220-83d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71610-220-83f5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050641-001MONODOXDOXYCYCLINEEQ 100MG BASECAPSULE / ORALABRLD1989-12-29
N050641-002MONODOXDOXYCYCLINEEQ 50MG BASECAPSULE / ORALABRLD1992-02-10
N050641-003MONODOXDOXYCYCLINEEQ 75MG BASECAPSULE / ORALABRLD2006-10-18
N050641-004MONODOXDOXYCYCLINEEQ 150MG BASECAPSULE / ORALABRLD2022-02-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
N050641-001AB
N050641-002AB
N050641-003AB
N050641-004AB

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 4 · 154 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N050641-001MONODOXEQ 100MG BASECAPSULE / ORALABRLD1989-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050641-002MONODOXEQ 50MG BASECAPSULE / ORALABRLD1992-02-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050641-003MONODOXEQ 75MG BASECAPSULE / ORALABRLD2006-10-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050641-004MONODOXEQ 150MG BASECAPSULE / ORALABRLD2022-02-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050641-001MONODOXEQ 100MG BASECAPSULE / ORALABRLD1989-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050641-002MONODOXEQ 50MG BASECAPSULE / ORALABRLD1992-02-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050641-003MONODOXEQ 75MG BASECAPSULE / ORALABRLD2006-10-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050641-004MONODOXEQ 150MG BASECAPSULE / ORALABRLD2022-02-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08N050641-001MONODOXEQ 100MG BASECAPSULE / ORALABRLD1989-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050641-002MONODOXEQ 50MG BASECAPSULE / ORALABRLD1992-02-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050641-003MONODOXEQ 75MG BASECAPSULE / ORALABRLD2006-10-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050641-004MONODOXEQ 150MG BASECAPSULE / ORALABRLD2022-02-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050641-001MONODOXEQ 100MG BASECAPSULE / ORALABRLD1989-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050641-002MONODOXEQ 50MG BASECAPSULE / ORALABRLD1992-02-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050641-003MONODOXEQ 75MG BASECAPSULE / ORALABRLD2006-10-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050641-004MONODOXEQ 150MG BASECAPSULE / ORALABRLD2022-02-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050641-001MONODOXEQ 100MG BASECAPSULE / ORALABRLD1989-12-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050641-002MONODOXEQ 50MG BASECAPSULE / ORALABRLD1992-02-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050641-003MONODOXEQ 75MG BASECAPSULE / ORALABRLD2006-10-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050641-004MONODOXEQ 150MG BASECAPSULE / ORALABRLD2022-02-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050641-001MONODOXEQ 100MG BASECAPSULE / ORALABRLD1989-12-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050641-002MONODOXEQ 50MG BASECAPSULE / ORALABRLD1992-02-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050641-003MONODOXEQ 75MG BASECAPSULE / ORALABRLD2006-10-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050641-004MONODOXEQ 150MG BASECAPSULE / ORALABRLD2022-02-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050641-001MONODOXEQ 100MG BASECAPSULE / ORALABRLD1989-12-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050641-002MONODOXEQ 50MG BASECAPSULE / ORALABRLD1992-02-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050641-003MONODOXEQ 75MG BASECAPSULE / ORALABRLD2006-10-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050641-004MONODOXEQ 150MG BASECAPSULE / ORALABRLD2022-02-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050641-001MONODOXEQ 100MG BASECAPSULE / ORALABRLD1989-12-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050641-002MONODOXEQ 50MG BASECAPSULE / ORALABRLD1992-02-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050641-003MONODOXEQ 75MG BASECAPSULE / ORALABRLD2006-10-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050641-004MONODOXEQ 150MG BASECAPSULE / ORALABRLD2022-02-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050641-001MONODOXEQ 100MG BASECAPSULE / ORALABRLD1989-12-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050641-002MONODOXEQ 50MG BASECAPSULE / ORALABRLD1992-02-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050641-003MONODOXEQ 75MG BASECAPSULE / ORALABRLD2006-10-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050641-004MONODOXEQ 150MG BASECAPSULE / ORALABRLD2022-02-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050641-001MONODOXEQ 100MG BASECAPSULE / ORALABRLD1989-12-29d06236e962d9…
2024-10-29 15:01 UTC2024-10N050641-002MONODOXEQ 50MG BASECAPSULE / ORALABRLD1992-02-10d06236e962d9…
2024-10-29 15:01 UTC2024-10N050641-003MONODOXEQ 75MG BASECAPSULE / ORALABRLD2006-10-18d06236e962d9…
2024-10-29 15:01 UTC2024-10N050641-004MONODOXEQ 150MG BASECAPSULE / ORALABRLD2022-02-17d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 136 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N050641-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050641-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050641-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050641-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050641-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050641-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050641-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050641-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N050641-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050641-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050641-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050641-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050641-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050641-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050641-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050641-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050641-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050641-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050641-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050641-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050641-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050641-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050641-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050641-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050641-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050641-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050641-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050641-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050641-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050641-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050641-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050641-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050641-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050641-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050641-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050641-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050641-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N050641-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N050641-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N050641-004AB1d06236e962d9…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-220-83EA - Each71610-2201a0013d4-6549-4282-af1e-b4d76564bf4312019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-220DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC20190118_c8e674d7-3974-4aa7-b78c-7edb3df44fff.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoxycyclineDOXYCYCLINEWellhouse Pharma, LLC57f97f68-11fb-4900-9efb-ca3b00818d8e2026-07-24Warnings, Adverse reactionsExact identifier
application applno (NDA): 050641
application number: NDA050641
Doxycycline MonohydrateDOXYCYCLINE MONOHYDRATEChartwell RX, LLC.02aa8731-d40f-43d8-8b63-a79a0503f8db2025-07-25Warnings, Adverse reactionsExact identifier
application applno (NDA): 050641
application number: NDA050641

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-220-83716100220833600 CAPSULE in 1 BOTTLE (71610-220-83) 3600 capsule2019-01-080000-00-00NoNoCurrent