Home NDC 53002-0671-0 Doxycycline Monohydrate
Product NDC 53002-0671
Requested package NDC 53002-0671-0
11-digit product format 530020671
Labeler code 53002
Product ID 53002-0671_f7d2ac99-2ff1-4ffa-996e-230b953287b9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxycycline
Dosage form CAPSULE
Route ORAL
Labeler RPK Pharmaceuticals, Inc.
Application NDA050641
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2005-02-07
Marketing end 0000-00-00
Substance DOXYCYCLINE
Active strength 100 mg/1
Pharmacologic classes Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag No
Listing certified through 2021-12-31
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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53002-0671-0 Doxycycline Monohydrate 100 in 1 BOTTLE CAPSULE 100 1 53002-0671-1 Doxycycline Monohydrate 2 in 1 BOTTLE CAPSULE 2 1 53002-0671-2 Doxycycline Monohydrate 10 in 1 BOTTLE CAPSULE 10 1 53002-0671-3 Doxycycline Monohydrate 14 in 1 BOTTLE CAPSULE 14 1 53002-0671-4 Doxycycline Monohydrate 20 in 1 BOTTLE CAPSULE 20 1 53002-0671-5 Doxycycline Monohydrate 28 in 1 BOTTLE CAPSULE 28 1 53002-0671-6 Doxycycline Monohydrate 30 in 1 BOTTLE CAPSULE 30 1 53002-0671-7 Doxycycline Monohydrate 40 in 1 BOTTLE CAPSULE 40 1 53002-0671-9 Doxycycline Monohydrate 60 in 1 BOTTLE CAPSULE 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53002-0671 DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [RPK PHARMACEUTICALS, INC.] 1 Legacy NDC, 9 package rows 20201225_8ced6ac0-22f2-42d2-bced-4a97da5507a0.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 · 2 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 53002-0671-0 53002067100 100 CAPSULE in 1 BOTTLE (53002-0671-0) 100 capsule 2019-01-01 0000-00-00 No No Current