Home NDC 69097-228 Doxycycline
Product NDC 69097-228
11-digit product format 690970228
Labeler code 69097
Product ID 69097-228_198228e6-51ee-4825-8b01-18b9a2c996db
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DOXYCYCLINE
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler CIPLA USA, Inc
Application ANDA065454
Marketing category ANDA
Marketing start 2008-07-16
Marketing end 2022-08-01
Substance DOXYCYCLINE
Active strength 25 mg/5mL
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 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 · 24 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 69097-228-43 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 69097-228-43 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 69097-228-43 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 69097-228-43 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 69097-228-43 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 69097-228-43 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 69097-228-43 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 69097-228-43 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 69097-228-43 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 69097-228-43 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 69097-228-43 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 69097-228-43 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065454-001 DOXYCYCLINE DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065454-001 AB
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 2 · 41 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 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A065454-001 DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-07-16 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DOXYCYCLINE ACTIVE INGREDIENT N12000U13O DOXYCYCLINE POWDER, FOR SUSPENSION [CIPLA USA, INC] 1 DOXYCYCLINE ANHYDROUS ACTIVE MOIETY 334895S862 DOXYCYCLINE POWDER, FOR SUSPENSION [CIPLA USA, INC] 1 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 DOXYCYCLINE POWDER, FOR SUSPENSION [CIPLA USA, INC] 1 D&C RED NO. 27 INACTIVE INGREDIENT 2LRS185U6K DOXYCYCLINE POWDER, FOR SUSPENSION [CIPLA USA, INC] 1 ETHYL ACETATE INACTIVE INGREDIENT 76845O8NMZ DOXYCYCLINE POWDER, FOR SUSPENSION [CIPLA USA, INC] 1 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D DOXYCYCLINE POWDER, FOR SUSPENSION [CIPLA USA, INC] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T DOXYCYCLINE POWDER, FOR SUSPENSION [CIPLA USA, INC] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH DOXYCYCLINE POWDER, FOR SUSPENSION [CIPLA USA, INC] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 DOXYCYCLINE POWDER, FOR SUSPENSION [CIPLA USA, INC] 1
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69097-228-43 69097022843 60 mL in 1 BOTTLE, GLASS (69097-228-43) 60 ml 2008-07-16 2022-08-01 No No Current