Minocin

Product NDC
43353-172
11-digit product format
433530172
Labeler code
43353
Product ID
43353-172_ed662f55-b226-4b47-8004-a5ff89f91003
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
minocycline hydrochloride
Dosage form
CAPSULE, COATED PELLETS
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
NDA050649
Marketing category
NDA
Marketing start
1990-05-31
Marketing end
0000-00-00
Substance
MINOCYCLINE HYDROCHLORIDE
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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43353-172DDiscontinued by firm2026-08-03
excluded packagepackage43353-17243353-172-83DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 4 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct43353-172DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43353-17243353-172-83DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproduct43353-172DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43353-17243353-172-83DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050649-001MINOCINMINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALABRLD1990-05-31
N050649-002MINOCINMINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALABRLD1990-05-31
N050649-003MINOCINMINOCYCLINE HYDROCHLORIDEEQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2001-02-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N050649-001AB
N050649-002AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N050649-001MINOCINEQ 50MG BASECAPSULE / ORALABRLD1990-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050649-002MINOCINEQ 100MG BASECAPSULE / ORALABRLD1990-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050649-003MINOCINEQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2001-02-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050649-001MINOCINEQ 50MG BASECAPSULE / ORALABRLD1990-05-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050649-002MINOCINEQ 100MG BASECAPSULE / ORALABRLD1990-05-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050649-003MINOCINEQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2001-02-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08N050649-001MINOCINEQ 50MG BASECAPSULE / ORALABRLD1990-05-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050649-002MINOCINEQ 100MG BASECAPSULE / ORALABRLD1990-05-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050649-003MINOCINEQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2001-02-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050649-001MINOCINEQ 50MG BASECAPSULE / ORALABRLD1990-05-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050649-002MINOCINEQ 100MG BASECAPSULE / ORALABRLD1990-05-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050649-003MINOCINEQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2001-02-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050649-001MINOCINEQ 50MG BASECAPSULE / ORALABRLD1990-05-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050649-002MINOCINEQ 100MG BASECAPSULE / ORALABRLD1990-05-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050649-003MINOCINEQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2001-02-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050649-001MINOCINEQ 50MG BASECAPSULE / ORALABRLD1990-05-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050649-002MINOCINEQ 100MG BASECAPSULE / ORALABRLD1990-05-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050649-003MINOCINEQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2001-02-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050649-001MINOCINEQ 50MG BASECAPSULE / ORALABRLD1990-05-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050649-002MINOCINEQ 100MG BASECAPSULE / ORALABRLD1990-05-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050649-003MINOCINEQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2001-02-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050649-001MINOCINEQ 50MG BASECAPSULE / ORALABRLD1990-05-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050649-002MINOCINEQ 100MG BASECAPSULE / ORALABRLD1990-05-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050649-003MINOCINEQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2001-02-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050649-001MINOCINEQ 50MG BASECAPSULE / ORALABRLD1990-05-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050649-002MINOCINEQ 100MG BASECAPSULE / ORALABRLD1990-05-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050649-003MINOCINEQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2001-02-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050649-001MINOCINEQ 50MG BASECAPSULE / ORALABRLD1990-05-31d06236e962d9…
2024-10-29 15:01 UTC2024-10N050649-002MINOCINEQ 100MG BASECAPSULE / ORALABRLD1990-05-31d06236e962d9…
2024-10-29 15:01 UTC2024-10N050649-003MINOCINEQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2001-02-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050649-001MINOCINEQ 50MG BASECAPSULE / ORALABRLD1990-05-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050649-002MINOCINEQ 100MG BASECAPSULE / ORALABRLD1990-05-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050649-003MINOCINEQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2001-02-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050649-001MINOCINEQ 50MG BASECAPSULE / ORALABRLD1990-05-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050649-002MINOCINEQ 100MG BASECAPSULE / ORALABRLD1990-05-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050649-003MINOCINEQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2001-02-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050649-001MINOCINEQ 50MG BASECAPSULE / ORALABRLD1990-05-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050649-002MINOCINEQ 100MG BASECAPSULE / ORALABRLD1990-05-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050649-003MINOCINEQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2001-02-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050649-001MINOCINEQ 50MG BASECAPSULE / ORALABRLD1990-05-318072bd15b7f6…

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 UTC2026-02N050649-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050649-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050649-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050649-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N050649-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050649-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050649-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050649-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050649-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050649-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050649-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050649-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050649-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050649-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050649-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050649-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050649-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050649-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050649-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N050649-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050649-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050649-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050649-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050649-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050649-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050649-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050649-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N050649-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050649-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050649-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050649-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N050649-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050649-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N050649-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050649-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050649-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050649-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N050649-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050649-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N050649-002AB1782e0a99824c…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-172-83EA - Each43353-172fed21ceb-ab3d-4127-995b-8599ac7eb0c112016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-172MINOCIN (MINOCYCLINE HYDROCHLORIDE) CAPSULE, COATED PELLETS [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3Legacy NDC20171012_6dd5b14b-ebfc-49a2-ac63-429f9a8b974f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43353-172-83433530172833600 CAPSULE, COATED PELLETS in 1 BOTTLE (43353-172-83) 2016-04-150000-00-00NoNoCurrent