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 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.
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
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
DailyMed RxNorm Mappings#