Home NDC 72189-358 Doxycycline Monohydrate
Product NDC 72189-358
11-digit product format 721890358
Labeler code 72189
Product ID 72189-358_2c4c8dd5-f079-0339-e063-6394a90afedb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxycycline Monohydrate
Dosage form CAPSULE
Route ORAL
Labeler Direct_Rx
Application ANDA065053
Marketing category ANDA
Marketing start 2022-05-26
Substance DOXYCYCLINE
Active strength 100 mg/1
Pharmacologic classes Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 excluded product product 72189-358 U Excluded because listing certification expired excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 72189-358 72189-358-20 U Excluded because listing certification expired excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 72189-358 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 72189-358 72189-358-20 U Excluded because listing certification expired excluded / ndc_excluded.zip 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 A065053-001 DOXYCYCLINE DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL AB 2000-11-22 A065053-002 DOXYCYCLINE DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL AB RS 2000-11-22 A065053-003 DOXYCYCLINE DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL AB 2003-09-10
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 A065053-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL AB 2000-11-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065053-002 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL AB RS 2000-11-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065053-003 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL AB 2003-09-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065053-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL AB 2000-11-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065053-002 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL AB RS 2000-11-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065053-003 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL AB 2003-09-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065053-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL AB 2000-11-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065053-002 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL AB RS 2000-11-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065053-003 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL AB 2003-09-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065053-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL AB 2000-11-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065053-002 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL AB RS 2000-11-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065053-003 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL AB 2003-09-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065053-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL AB 2000-11-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065053-002 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL AB RS 2000-11-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065053-003 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL AB 2003-09-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065053-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL AB 2000-11-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065053-002 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL AB RS 2000-11-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065053-003 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL AB 2003-09-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065053-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL AB 2000-11-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065053-002 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL AB RS 2000-11-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065053-003 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL AB 2003-09-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065053-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL AB 2000-11-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065053-002 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL AB RS 2000-11-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065053-003 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL AB 2003-09-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065053-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL AB 2000-11-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065053-002 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL AB RS 2000-11-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065053-003 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL AB 2003-09-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065053-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL AB 2000-11-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065053-002 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL AB RS 2000-11-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065053-003 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL AB 2003-09-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065053-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL AB 2000-11-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065053-002 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL AB RS 2000-11-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065053-003 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL AB 2003-09-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065053-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL AB 2000-11-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065053-002 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL AB RS 2000-11-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065053-003 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL AB 2003-09-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065053-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL AB 2000-11-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065053-002 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL AB RS 2000-11-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065053-003 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL AB 2003-09-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065053-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL AB 2000-11-22 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
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 · 3 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Doxycycline Monohydrate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOXYCYCLINE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination N12000U13O Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1649990 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 72189-358-20 Doxycycline Monohydrate 20 in 1 BOTTLE CAPSULE 20 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72189-358 DOXYCYCLINE MONOHYDRATE CAPSULE [DIRECT_RX] 2 Current NDC, Legacy NDC, 1 package rows 20250123_dfef600c-bceb-fbc9-e053-2a95a90ae6c0.zip
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 72189-358-20 72189035820 20 CAPSULE in 1 BOTTLE (72189-358-20) 20 capsule 2022-05-26 0000-00-00 No No Current