Home NDC 80425-0319 Doxycycline Monohydrate
Product NDC 80425-0319
11-digit product format 804250319
Labeler code 80425
Product ID 80425-0319_2a9bf7d3-46da-0dfa-e063-6394a90a76a4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxycycline Monohydrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Advanced Rx Pharmacy of Tennessee, LLC
Application ANDA209582
Marketing category ANDA
Marketing start 2023-04-11
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A209582-001 DOXYCYCLINE DOXYCYCLINE EQ 50MG BASE TABLET / ORAL AB 2017-09-28 A209582-002 DOXYCYCLINE DOXYCYCLINE EQ 75MG BASE TABLET / ORAL AB 2017-09-28 A209582-003 DOXYCYCLINE DOXYCYCLINE EQ 100MG BASE TABLET / ORAL AB 2017-09-28 A209582-004 DOXYCYCLINE DOXYCYCLINE EQ 150MG BASE TABLET / ORAL AB 2017-09-28
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 5 · 176 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 2026-10-15 13:18:30 2026-09 A209582-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL AB 2017-09-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 A209582-002 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL AB 2017-09-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 A209582-003 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL AB 2017-09-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 A209582-004 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL AB 2017-09-28 c2088c7a36db…2026-09-14 22:38:34 2026-08 A209582-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL AB 2017-09-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209582-002 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL AB 2017-09-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209582-003 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL AB 2017-09-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209582-004 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL AB 2017-09-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A209582-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL AB 2017-09-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209582-002 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL AB 2017-09-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209582-003 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL AB 2017-09-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209582-004 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL AB 2017-09-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209582-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL AB 2017-09-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209582-002 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL AB 2017-09-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209582-003 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL AB 2017-09-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209582-004 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL AB 2017-09-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209582-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL AB 2017-09-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209582-002 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL AB 2017-09-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209582-003 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL AB 2017-09-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209582-004 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL AB 2017-09-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209582-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL AB 2017-09-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209582-002 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL AB 2017-09-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209582-003 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL AB 2017-09-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209582-004 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL AB 2017-09-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209582-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL AB 2017-09-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209582-002 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL AB 2017-09-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209582-003 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL AB 2017-09-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209582-004 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL AB 2017-09-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209582-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL AB 2017-09-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209582-002 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL AB 2017-09-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209582-003 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL AB 2017-09-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209582-004 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL AB 2017-09-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209582-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL AB 2017-09-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209582-002 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL AB 2017-09-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209582-003 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL AB 2017-09-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209582-004 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL AB 2017-09-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209582-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL AB 2017-09-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209582-002 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL AB 2017-09-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209582-003 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL AB 2017-09-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209582-004 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL AB 2017-09-28 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 176 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 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 1650142 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 80425-0319-1 Doxycycline Monohydrate 30 in 1 BOTTLE TABLET, FILM COATED 30 2 80425-0319-2 Doxycycline Monohydrate 60 in 1 BOTTLE TABLET, FILM COATED 60 2 80425-0319-3 Doxycycline Monohydrate 90 in 1 BOTTLE TABLET, FILM COATED 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80425-0319 DOXYCYCLINE MONOHYDRATE TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC] 2 Current NDC, 3 package rows 20250102_f91373f2-c57b-f1f1-e053-6294a90a7bdd.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 Marketing start Sample Exclude flag Status 80425-0319-1 80425031901 30 TABLET, FILM COATED in 1 BOTTLE (80425-0319-1) 2023-04-11 No No Current 80425-0319-2 80425031902 60 TABLET, FILM COATED in 1 BOTTLE (80425-0319-2) 2023-04-11 No No Current 80425-0319-3 80425031903 90 TABLET, FILM COATED in 1 BOTTLE (80425-0319-3) 2023-04-11 No No Current