Home NDC 16781-403 Minocin
Product NDC 16781-403
11-digit product format 167810403
Labeler code 16781
Product ID 16781-403_bdd0be98-5e2c-4115-a434-3eced718541e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name minocycline hydrochloride
Dosage form CAPSULE, COATED PELLETS
Route ORAL
Labeler Bausch Health US, 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 2021-12-31
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 · 60 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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MINOCIN MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2001-02-12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 · 132 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 2026-10-15 13:18:30 2026-09 N050649-001 MINOCIN EQ 50MG BASE CAPSULE / ORAL AB RLD 1990-05-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 N050649-002 MINOCIN EQ 100MG BASE CAPSULE / ORAL AB RLD 1990-05-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 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 c2088c7a36db…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…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 3 · 88 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MINOCYCLINE HYDROCHLORIDE ACTIVE INGREDIENT 0020414E5U MINOCIN (MINOCYCLINE HYDROCHLORIDE) CAPSULE, COATED PELLETS [ONSET DERMATOLOGICS LLC] 3 MINOCYCLINE ACTIVE MOIETY FYY3R43WGO MINOCIN (MINOCYCLINE HYDROCHLORIDE) CAPSULE, COATED PELLETS [ONSET DERMATOLOGICS LLC] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G MINOCIN (MINOCYCLINE HYDROCHLORIDE) CAPSULE, COATED PELLETS [ONSET DERMATOLOGICS LLC] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD MINOCIN (MINOCYCLINE HYDROCHLORIDE) CAPSULE, COATED PELLETS [ONSET DERMATOLOGICS LLC] 3 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT MINOCIN (MINOCYCLINE HYDROCHLORIDE) CAPSULE, COATED PELLETS [ONSET DERMATOLOGICS LLC] 3 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 MINOCIN (MINOCYCLINE HYDROCHLORIDE) CAPSULE, COATED PELLETS [ONSET DERMATOLOGICS LLC] 3 GELATIN INACTIVE INGREDIENT 2G86QN327L MINOCIN (MINOCYCLINE HYDROCHLORIDE) CAPSULE, COATED PELLETS [ONSET DERMATOLOGICS LLC] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MINOCIN (MINOCYCLINE HYDROCHLORIDE) CAPSULE, COATED PELLETS [ONSET DERMATOLOGICS LLC] 3