Home NDC 55289-201 Minocycline Hydrochloride
Product NDC 55289-201
11-digit product format 552890201
Labeler code 55289
Product ID 55289-201_2abe5cd1-1aa6-fab2-e063-6294a90a8abe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Minocycline Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA063065
Marketing category ANDA
Marketing start 1993-05-01
Substance MINOCYCLINE HYDROCHLORIDE
Active strength 100 mg/1
Pharmacologic classes Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A063065-001 MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 1991-12-30 A063065-002 MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1999-06-10
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 3 · 82 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 A063065-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 1991-12-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A063065-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1999-06-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A063065-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 1991-12-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A063065-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1999-06-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A063065-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 1991-12-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A063065-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1999-06-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A063065-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 1991-12-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A063065-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1999-06-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A063065-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 1991-12-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A063065-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1999-06-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A063065-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 1991-12-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A063065-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1999-06-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A063065-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 1991-12-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A063065-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1999-06-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A063065-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 1991-12-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A063065-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1999-06-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A063065-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 1991-12-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A063065-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1999-06-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A063065-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 1991-12-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A063065-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1999-06-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A063065-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 1991-12-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A063065-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1999-06-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A063065-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 1991-12-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A063065-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1999-06-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A063065-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 1991-12-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A063065-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1999-06-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A063065-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 1991-12-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A063065-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1999-06-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A063065-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 1991-12-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A063065-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1999-06-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A063065-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 1991-12-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A063065-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1999-06-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A063065-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 1991-12-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A063065-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1999-06-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A063065-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 1991-12-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A063065-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1999-06-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A063065-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 1991-12-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A063065-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1999-06-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A063065-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB 1991-12-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A063065-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1999-06-10 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
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 100 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197984 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 55289-201-14 Minocycline Hydrochloride 14 in 1 BOTTLE, PLASTIC CAPSULE 14 27 55289-201-20 Minocycline Hydrochloride 20 in 1 BOTTLE, PLASTIC CAPSULE 20 27 55289-201-30 Minocycline Hydrochloride 30 in 1 BOTTLE, PLASTIC CAPSULE 30 27
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MINOCYCLINE HYDROCHLORIDE ACTIVE INGREDIENT 0020414E5U MINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 12 MINOCYCLINE ACTIVE MOIETY FYY3R43WGO MINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 12 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH MINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 12 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G MINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 12 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 MINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 12 GELATIN INACTIVE INGREDIENT 2G86QN327L MINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 12 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 12 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 12 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J MINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 12 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ MINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 12 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55289-201 MINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 27 Current NDC, Legacy NDC, 3 package rows 20250104_87a137c6-dd53-44d3-ab49-ef78ebed35c8.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 · 5 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 55289-201-14 55289020114 14 CAPSULE in 1 BOTTLE, PLASTIC (55289-201-14) 14 capsule 2011-08-30 0000-00-00 No No Current 55289-201-20 55289020120 20 CAPSULE in 1 BOTTLE, PLASTIC (55289-201-20) 20 capsule 2011-08-30 0000-00-00 No No Current 55289-201-30 55289020130 30 CAPSULE in 1 BOTTLE, PLASTIC (55289-201-30) 30 capsule 2011-08-30 0000-00-00 No No Current