Home NDC 43353-172 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 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 date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 43353-172-83 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 43353-172-83 f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N050649-001 MINOCIN MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB RLD 1990-05-31 N050649-002 MINOCIN MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB RLD 1990-05-31 N050649-003 MINOCIN MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2001-02-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 129 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N050649-001 MINOCIN EQ 50MG BASE CAPSULE / ORAL AB RLD 1990-05-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N050649-002 MINOCIN EQ 100MG BASE CAPSULE / ORAL AB RLD 1990-05-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N050649-003 MINOCIN EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2001-02-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 N050649-001 MINOCIN EQ 50MG BASE CAPSULE / ORAL AB RLD 1990-05-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N050649-002 MINOCIN EQ 100MG BASE CAPSULE / ORAL AB RLD 1990-05-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N050649-003 MINOCIN EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2001-02-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N050649-001 MINOCIN EQ 50MG BASE CAPSULE / ORAL AB RLD 1990-05-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050649-002 MINOCIN EQ 100MG BASE CAPSULE / ORAL AB RLD 1990-05-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050649-003 MINOCIN EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2001-02-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050649-001 MINOCIN EQ 50MG BASE CAPSULE / ORAL AB RLD 1990-05-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050649-002 MINOCIN EQ 100MG BASE CAPSULE / ORAL AB RLD 1990-05-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050649-003 MINOCIN EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2001-02-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050649-001 MINOCIN EQ 50MG BASE CAPSULE / ORAL AB RLD 1990-05-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050649-002 MINOCIN EQ 100MG BASE CAPSULE / ORAL AB RLD 1990-05-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050649-003 MINOCIN EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2001-02-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050649-001 MINOCIN EQ 50MG BASE CAPSULE / ORAL AB RLD 1990-05-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050649-002 MINOCIN EQ 100MG BASE CAPSULE / ORAL AB RLD 1990-05-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050649-003 MINOCIN EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2001-02-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050649-001 MINOCIN EQ 50MG BASE CAPSULE / ORAL AB RLD 1990-05-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050649-002 MINOCIN EQ 100MG BASE CAPSULE / ORAL AB RLD 1990-05-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050649-003 MINOCIN EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2001-02-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050649-001 MINOCIN EQ 50MG BASE CAPSULE / ORAL AB RLD 1990-05-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050649-002 MINOCIN EQ 100MG BASE CAPSULE / ORAL AB RLD 1990-05-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050649-003 MINOCIN EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2001-02-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050649-001 MINOCIN EQ 50MG BASE CAPSULE / ORAL AB RLD 1990-05-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050649-002 MINOCIN EQ 100MG BASE CAPSULE / ORAL AB RLD 1990-05-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050649-003 MINOCIN EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2001-02-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050649-001 MINOCIN EQ 50MG BASE CAPSULE / ORAL AB RLD 1990-05-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050649-002 MINOCIN EQ 100MG BASE CAPSULE / ORAL AB RLD 1990-05-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050649-003 MINOCIN EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2001-02-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050649-001 MINOCIN EQ 50MG BASE CAPSULE / ORAL AB RLD 1990-05-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050649-002 MINOCIN EQ 100MG BASE CAPSULE / ORAL AB RLD 1990-05-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050649-003 MINOCIN EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2001-02-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050649-001 MINOCIN EQ 50MG BASE CAPSULE / ORAL AB RLD 1990-05-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050649-002 MINOCIN EQ 100MG BASE CAPSULE / ORAL AB RLD 1990-05-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050649-003 MINOCIN EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2001-02-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050649-001 MINOCIN EQ 50MG BASE CAPSULE / ORAL AB RLD 1990-05-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050649-002 MINOCIN EQ 100MG BASE CAPSULE / ORAL AB RLD 1990-05-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050649-003 MINOCIN EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2001-02-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050649-001 MINOCIN EQ 50MG BASE CAPSULE / ORAL AB RLD 1990-05-31 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 3 · 86 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43353-172 MINOCIN (MINOCYCLINE HYDROCHLORIDE) CAPSULE, COATED PELLETS [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 Legacy NDC 20171012_6dd5b14b-ebfc-49a2-ac63-429f9a8b974f.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 43353-172-83 43353017283 3600 CAPSULE, COATED PELLETS in 1 BOTTLE (43353-172-83) 2016-04-15 0000-00-00 No No Current