Home NDC 0591-0411 Doxycycline Monohydrate
Product NDC 0591-0411
11-digit product format 005910411
Labeler code 0591
Product ID 0591-0411_87ec24be-f5bb-46ef-90fa-d818e0969f07
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxycycline
Dosage form CAPSULE
Route ORAL
Labeler Actavis Pharma, Inc.
Application NDA050641
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2005-02-07
Marketing end 2020-01-31
Substance DOXYCYCLINE
Active strength 100 mg/1
Pharmacologic classes Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag No
Listing certified through 0000-00-00
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.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N050641-001 MONODOX DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL AB RLD 1989-12-29 N050641-002 MONODOX DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL AB RLD 1992-02-10 N050641-003 MONODOX DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL AB RLD 2006-10-18 N050641-004 MONODOX DOXYCYCLINE EQ 150MG BASE CAPSULE / ORAL AB RLD 2022-02-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 · 154 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 N050641-001 MONODOX EQ 100MG BASE CAPSULE / ORAL AB RLD 1989-12-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050641-002 MONODOX EQ 50MG BASE CAPSULE / ORAL AB RLD 1992-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050641-003 MONODOX EQ 75MG BASE CAPSULE / ORAL AB RLD 2006-10-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050641-004 MONODOX EQ 150MG BASE CAPSULE / ORAL AB RLD 2022-02-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050641-001 MONODOX EQ 100MG BASE CAPSULE / ORAL AB RLD 1989-12-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050641-002 MONODOX EQ 50MG BASE CAPSULE / ORAL AB RLD 1992-02-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050641-003 MONODOX EQ 75MG BASE CAPSULE / ORAL AB RLD 2006-10-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050641-004 MONODOX EQ 150MG BASE CAPSULE / ORAL AB RLD 2022-02-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050641-001 MONODOX EQ 100MG BASE CAPSULE / ORAL AB RLD 1989-12-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050641-002 MONODOX EQ 50MG BASE CAPSULE / ORAL AB RLD 1992-02-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050641-003 MONODOX EQ 75MG BASE CAPSULE / ORAL AB RLD 2006-10-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050641-004 MONODOX EQ 150MG BASE CAPSULE / ORAL AB RLD 2022-02-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050641-001 MONODOX EQ 100MG BASE CAPSULE / ORAL AB RLD 1989-12-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050641-002 MONODOX EQ 50MG BASE CAPSULE / ORAL AB RLD 1992-02-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050641-003 MONODOX EQ 75MG BASE CAPSULE / ORAL AB RLD 2006-10-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050641-004 MONODOX EQ 150MG BASE CAPSULE / ORAL AB RLD 2022-02-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050641-001 MONODOX EQ 100MG BASE CAPSULE / ORAL AB RLD 1989-12-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050641-002 MONODOX EQ 50MG BASE CAPSULE / ORAL AB RLD 1992-02-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050641-003 MONODOX EQ 75MG BASE CAPSULE / ORAL AB RLD 2006-10-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050641-004 MONODOX EQ 150MG BASE CAPSULE / ORAL AB RLD 2022-02-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050641-001 MONODOX EQ 100MG BASE CAPSULE / ORAL AB RLD 1989-12-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050641-002 MONODOX EQ 50MG BASE CAPSULE / ORAL AB RLD 1992-02-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050641-003 MONODOX EQ 75MG BASE CAPSULE / ORAL AB RLD 2006-10-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050641-004 MONODOX EQ 150MG BASE CAPSULE / ORAL AB RLD 2022-02-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050641-001 MONODOX EQ 100MG BASE CAPSULE / ORAL AB RLD 1989-12-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050641-002 MONODOX EQ 50MG BASE CAPSULE / ORAL AB RLD 1992-02-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050641-003 MONODOX EQ 75MG BASE CAPSULE / ORAL AB RLD 2006-10-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050641-004 MONODOX EQ 150MG BASE CAPSULE / ORAL AB RLD 2022-02-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050641-001 MONODOX EQ 100MG BASE CAPSULE / ORAL AB RLD 1989-12-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050641-002 MONODOX EQ 50MG BASE CAPSULE / ORAL AB RLD 1992-02-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050641-003 MONODOX EQ 75MG BASE CAPSULE / ORAL AB RLD 2006-10-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050641-004 MONODOX EQ 150MG BASE CAPSULE / ORAL AB RLD 2022-02-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050641-001 MONODOX EQ 100MG BASE CAPSULE / ORAL AB RLD 1989-12-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050641-002 MONODOX EQ 50MG BASE CAPSULE / ORAL AB RLD 1992-02-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050641-003 MONODOX EQ 75MG BASE CAPSULE / ORAL AB RLD 2006-10-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050641-004 MONODOX EQ 150MG BASE CAPSULE / ORAL AB RLD 2022-02-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050641-001 MONODOX EQ 100MG BASE CAPSULE / ORAL AB RLD 1989-12-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050641-002 MONODOX EQ 50MG BASE CAPSULE / ORAL AB RLD 1992-02-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050641-003 MONODOX EQ 75MG BASE CAPSULE / ORAL AB RLD 2006-10-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050641-004 MONODOX EQ 150MG BASE CAPSULE / ORAL AB RLD 2022-02-17 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 136 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DOXYCYCLINE ACTIVE INGREDIENT N12000U13O DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 18 DOXYCYCLINE ANHYDROUS ACTIVE MOIETY 334895S862 DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 18 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 18 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 18 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 18 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 18 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 18 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 18 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 18 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 18 DOXYCYCLINE ACTIVE INGREDIENT N12000U13O DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [ACTAVIS PHARMA, INC.] 15 DOXYCYCLINE ANHYDROUS ACTIVE MOIETY 334895S862 DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [ACTAVIS PHARMA, INC.] 15 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [ACTAVIS PHARMA, INC.] 15 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [ACTAVIS PHARMA, INC.] 15 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [ACTAVIS PHARMA, INC.] 15 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [ACTAVIS PHARMA, INC.] 15 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [ACTAVIS PHARMA, INC.] 15 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [ACTAVIS PHARMA, INC.] 15 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [ACTAVIS PHARMA, INC.] 15 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [ACTAVIS PHARMA, INC.] 15 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [ACTAVIS PHARMA, INC.] 15 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [ACTAVIS PHARMA, INC.] 15 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [ACTAVIS PHARMA, INC.] 15 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [ACTAVIS PHARMA, INC.] 15 DOXYCYCLINE ACTIVE INGREDIENT N12000U13O DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 2 DOXYCYCLINE ANHYDROUS ACTIVE MOIETY 334895S862 DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 2
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#