Home NDC 55111-639 Minocycline Hydrochloride
Product NDC 55111-639
11-digit product format 551110639
Labeler code 55111
Product ID 55111-639_ce7fa22b-68f0-23fb-6ee0-121a41f01ca7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Minocycline Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Dr. Reddy's Laboratories Limited
Application ANDA065436
Marketing category ANDA
Marketing start 2008-01-23
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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 55111-639-10 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 55111-639-60 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 55111-639-50 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 55111-639-10 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 55111-639-60 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 55111-639-50 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 55111-639-10 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 55111-639-60 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 55111-639-50 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 55111-639-10 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 55111-639-60 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 55111-639-50 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 55111-639-10 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 55111-639-60 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 55111-639-50 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 55111-639-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 55111-639-60 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 55111-639-50 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 55111-639-60 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 55111-639-10 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 55111-639-50 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 55111-639-60 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 55111-639-10 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 55111-639-50 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 55111-639-60 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 55111-639-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 55111-639-50 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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 A065436-001 MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2007-12-26 A065436-002 MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2007-12-26 A065436-003 MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2007-12-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 A065436-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2007-12-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A065436-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2007-12-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A065436-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2007-12-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A065436-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2007-12-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065436-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2007-12-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065436-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2007-12-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065436-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2007-12-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065436-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2007-12-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065436-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2007-12-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065436-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2007-12-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065436-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2007-12-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065436-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2007-12-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065436-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2007-12-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065436-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2007-12-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065436-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2007-12-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065436-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2007-12-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065436-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2007-12-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065436-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2007-12-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065436-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2007-12-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065436-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2007-12-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065436-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2007-12-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065436-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2007-12-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065436-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2007-12-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065436-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2007-12-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065436-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2007-12-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065436-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2007-12-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065436-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2007-12-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065436-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2007-12-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065436-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2007-12-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065436-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2007-12-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065436-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2007-12-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065436-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2007-12-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065436-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2007-12-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065436-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2007-12-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065436-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2007-12-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065436-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2007-12-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065436-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2007-12-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065436-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2007-12-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065436-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2007-12-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065436-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2007-12-26 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55111-639-10 Minocycline Hydrochloride 1000 in 1 BOTTLE TABLET, FILM COATED 1000 8 55111-639-50 Minocycline Hydrochloride 50 in 1 BOTTLE TABLET, FILM COATED 50 8 55111-639-60 Minocycline Hydrochloride 60 in 1 BOTTLE TABLET, FILM COATED 60 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Minocycline Hydrochloride ACTIVE INGREDIENT 0020414E5U MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 7 Minocycline ACTIVE MOIETY FYY3R43WGO MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 7 Cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 7 FD&C Blue No. 2 INACTIVE INGREDIENT L06K8R7DQK MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 7 FD&C Yellow No. 5 INACTIVE INGREDIENT I753WB2F1M MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 7 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 7 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 7 Lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 7 Magnesium Stearate INACTIVE INGREDIENT 70097M6I30 MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 7 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 7 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 7 Povidone INACTIVE INGREDIENT FZ989GH94E MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 7 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 7 Titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55111-639 MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 8 Legacy NDC, 3 package rows 20191211_aec056cd-4f1f-4971-2bea-0b05ee028889.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55111-639-10 55111063910 1000 TABLET, FILM COATED in 1 BOTTLE (55111-639-10) 2008-01-23 0000-00-00 No No Current 55111-639-50 55111063950 50 TABLET, FILM COATED in 1 BOTTLE (55111-639-50) 2008-01-23 0000-00-00 No No Current 55111-639-60 55111063960 60 TABLET, FILM COATED in 1 BOTTLE (55111-639-60) 2008-01-23 0000-00-00 No No Current