Home NDC 13668-486 MINOCYCLINE HYDROCHLORIDE
Product NDC 13668-486
11-digit product format 136680486
Labeler code 13668
Product ID 13668-486_3bd2bae3-7b58-42f2-8fc2-9c036b8a476d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MINOCYCLINE HYDROCHLORIDE
Dosage form TABLET
Route ORAL
Labeler Torrent Pharmaceuticals Limited
Application ANDA065156
Marketing category ANDA
Marketing start 2015-04-02
Substance MINOCYCLINE HYDROCHLORIDE
Active strength 75 mg/1
Pharmacologic classes Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 A065156-001 MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2004-01-06 A065156-002 MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2004-01-06 A065156-003 MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2004-01-06
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 A065156-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2004-01-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A065156-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2004-01-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A065156-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2004-01-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A065156-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2004-01-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065156-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2004-01-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065156-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2004-01-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065156-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2004-01-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065156-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2004-01-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065156-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2004-01-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065156-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2004-01-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065156-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2004-01-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065156-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2004-01-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065156-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2004-01-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065156-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2004-01-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065156-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2004-01-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065156-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2004-01-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065156-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2004-01-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065156-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2004-01-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065156-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2004-01-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065156-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2004-01-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065156-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2004-01-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065156-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2004-01-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065156-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2004-01-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065156-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2004-01-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065156-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2004-01-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065156-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2004-01-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065156-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2004-01-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065156-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2004-01-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065156-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2004-01-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065156-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2004-01-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065156-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2004-01-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065156-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2004-01-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065156-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2004-01-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065156-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2004-01-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065156-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2004-01-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065156-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2004-01-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065156-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2004-01-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065156-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2004-01-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065156-003 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2004-01-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065156-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2004-01-06 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.
Additional Listing Data#
Finished product Yes
Brand name base MINOCYCLINE HYDROCHLORIDE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MINOCYCLINE HYDROCHLORIDE 75 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0020414E5U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 207362 Internal RxNorm lookup 207364 Internal RxNorm lookup 403840 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 13668-486-01 MINOCYCLINE HYDROCHLORIDE 100 in 1 BOTTLE TABLET 100 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13668-486 MINOCYCLINE HYDROCHLORIDE TABLET [TORRENT PHARMACEUTICALS LIMITED] 10 Current NDC, Legacy NDC, 1 package rows 20250508_3539f84e-b489-4914-96c1-ac3731032971.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 13668-486-01 13668048601 100 TABLET in 1 BOTTLE (13668-486-01) 100 tablet 2015-04-02 0000-00-00 No No Current