Home NDC 49884-511-01 Minocycline
Product NDC 49884-511
Requested package NDC 49884-511-01
11-digit product format 498840511
Labeler code 49884
Product ID 49884-511_6b95ec55-8686-495a-b24c-4e4409a5c2e8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Minocycline
Dosage form TABLET
Route ORAL
Labeler Par Pharmaceutical, Inc.
Application ANDA065131
Marketing category ANDA
Marketing start 2003-04-16
Marketing end 0000-00-00
Substance MINOCYCLINE HYDROCHLORIDE
Active strength 50 mg/1
Pharmacologic classes Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065131-001 MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2003-04-16 A065131-002 MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2003-04-16 A065131-003 MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB RS 2003-04-16
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 · 123 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 2026-02-19 14:30 UTC 2026-02 A065131-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2003-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065131-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2003-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065131-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB RS 2003-04-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065131-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2003-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065131-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2003-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065131-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB RS 2003-04-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065131-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2003-04-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065131-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2003-04-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065131-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB RS 2003-04-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065131-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2003-04-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065131-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2003-04-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065131-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB RS 2003-04-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065131-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2003-04-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065131-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2003-04-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065131-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB RS 2003-04-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065131-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2003-04-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065131-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2003-04-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065131-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB RS 2003-04-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065131-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2003-04-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065131-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2003-04-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065131-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB RS 2003-04-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065131-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2003-04-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065131-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2003-04-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065131-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB RS 2003-04-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065131-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2003-04-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065131-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2003-04-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065131-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB RS 2003-04-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065131-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2003-04-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065131-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2003-04-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065131-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB RS 2003-04-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065131-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2003-04-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065131-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2003-04-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065131-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB RS 2003-04-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065131-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2003-04-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065131-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2003-04-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065131-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB RS 2003-04-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065131-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2003-04-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065131-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2003-04-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065131-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB RS 2003-04-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065131-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2003-04-16 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MINOCYCLINE HYDROCHLORIDE ACTIVE INGREDIENT 0020414E5U MINOCYCLINE (MINOCYCLINE) TABLET [PAR PHARMACEUTICAL, INC.] 3 MINOCYCLINE ACTIVE MOIETY FYY3R43WGO MINOCYCLINE (MINOCYCLINE) TABLET [PAR PHARMACEUTICAL, INC.] 3 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK MINOCYCLINE (MINOCYCLINE) TABLET [PAR PHARMACEUTICAL, INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MINOCYCLINE (MINOCYCLINE) TABLET [PAR PHARMACEUTICAL, INC.] 3 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MINOCYCLINE (MINOCYCLINE) TABLET [PAR PHARMACEUTICAL, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MINOCYCLINE (MINOCYCLINE) TABLET [PAR PHARMACEUTICAL, INC.] 3 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ MINOCYCLINE (MINOCYCLINE) TABLET [PAR PHARMACEUTICAL, INC.] 3 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H MINOCYCLINE (MINOCYCLINE) TABLET [PAR PHARMACEUTICAL, INC.] 3 POVIDONE K29/32 INACTIVE INGREDIENT 390RMW2PEQ MINOCYCLINE (MINOCYCLINE) TABLET [PAR PHARMACEUTICAL, INC.] 3 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 MINOCYCLINE (MINOCYCLINE) TABLET [PAR PHARMACEUTICAL, INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MINOCYCLINE (MINOCYCLINE) TABLET [PAR PHARMACEUTICAL, INC.] 3
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 49884-511-01 49884051101 100 TABLET in 1 BOTTLE (49884-511-01) 100 tablet 2003-04-16 0000-00-00 No No Current