Home NDC 16110-260 Monodox
Product NDC 16110-260
11-digit product format 161100260
Labeler code 16110
Product ID 16110-260_a6d054f6-c27d-4641-ae0e-a6f59a196f54
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name doxycycline
Dosage form CAPSULE
Route ORAL
Labeler Aqua Pharmaceuticals, LLC
Application NDA050641
Marketing category NDA
Marketing start 1992-02-10
Marketing end 0000-00-00
Substance DOXYCYCLINE
Active strength 50 mg/1
Pharmacologic classes Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag No
Listing certified through 2020-12-31
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 · 38 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 16110-260-06 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 16110-260-06 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 16110-260-06 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 16110-260-06 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 16110-260-06 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 16110-260-06 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 16110-260-06 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 16110-260-06 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 16110-260-06 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 16110-260-06 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 16110-260-06 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 16110-260-06 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 16110-260-06 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 16110-260-06 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 16110-260-06 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 16110-260-06 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 16110-260-06 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 16110-260-06 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 16110-260-06 8dfbde2a14a4…c9ff85d89658…
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 16110-260-06 Monodox 100 in 1 BOTTLE CAPSULE 100 18
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DOXYCYCLINE ACTIVE INGREDIENT N12000U13O MONODOX (DOXYCYCLINE) CAPSULE [AQUA PHARMACEUTICALS, LLC] 17 DOXYCYCLINE ANHYDROUS ACTIVE MOIETY 334895S862 MONODOX (DOXYCYCLINE) CAPSULE [AQUA PHARMACEUTICALS, LLC] 17 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MONODOX (DOXYCYCLINE) CAPSULE [AQUA PHARMACEUTICALS, LLC] 17 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G MONODOX (DOXYCYCLINE) CAPSULE [AQUA PHARMACEUTICALS, LLC] 17 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD MONODOX (DOXYCYCLINE) CAPSULE [AQUA PHARMACEUTICALS, LLC] 17 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK MONODOX (DOXYCYCLINE) CAPSULE [AQUA PHARMACEUTICALS, LLC] 17 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA MONODOX (DOXYCYCLINE) CAPSULE [AQUA PHARMACEUTICALS, LLC] 17 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 MONODOX (DOXYCYCLINE) CAPSULE [AQUA PHARMACEUTICALS, LLC] 17 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT MONODOX (DOXYCYCLINE) CAPSULE [AQUA PHARMACEUTICALS, LLC] 17 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 MONODOX (DOXYCYCLINE) CAPSULE [AQUA PHARMACEUTICALS, LLC] 17 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MONODOX (DOXYCYCLINE) CAPSULE [AQUA PHARMACEUTICALS, LLC] 17 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MONODOX (DOXYCYCLINE) CAPSULE [AQUA PHARMACEUTICALS, LLC] 17 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 MONODOX (DOXYCYCLINE) CAPSULE [AQUA PHARMACEUTICALS, LLC] 17 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MONODOX (DOXYCYCLINE) CAPSULE [AQUA PHARMACEUTICALS, LLC] 17
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16110-260 MONODOX (DOXYCYCLINE) CAPSULE [AQUA PHARMACEUTICALS, LLC] 18 Legacy NDC, 1 package rows 20170503_a65325a7-ae0a-4704-99c4-a3a2e4e1dcf2.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 Status 16110-260-06 16110026006 100 in 1 BOTTLE Historical