Home NDC 60505-4775 Doxycycline
Product NDC 60505-4775
11-digit product format 605054775
Labeler code 60505
Product ID 60505-4775_25ff4cd8-a10a-1c3e-5360-edfd3ecd93a1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxycycline
Dosage form CAPSULE
Route ORAL
Labeler Apotex Corp.
Application ANDA217170
Marketing category ANDA
Marketing start 2024-10-31
Substance DOXYCYCLINE
Active strength 40 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 · 10 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…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A217170-001 DOXYCYCLINE DOXYCYCLINE 40MG CAPSULE / ORAL AB 2024-07-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217170-001 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.
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 2026-09-14 22:38:34 2026-08 A217170-001 DOXYCYCLINE 40MG CAPSULE / ORAL AB 2024-07-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217170-001 DOXYCYCLINE 40MG CAPSULE / ORAL AB 2024-07-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217170-001 DOXYCYCLINE 40MG CAPSULE / ORAL AB 2024-07-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217170-001 DOXYCYCLINE 40MG CAPSULE / ORAL AB 2024-07-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217170-001 DOXYCYCLINE 40MG CAPSULE / ORAL AB 2024-07-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217170-001 DOXYCYCLINE 40MG CAPSULE / ORAL AB 2024-07-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217170-001 DOXYCYCLINE 40MG CAPSULE / ORAL AB 2024-07-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217170-001 DOXYCYCLINE 40MG CAPSULE / ORAL AB 2024-07-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217170-001 DOXYCYCLINE 40MG CAPSULE / ORAL AB 2024-07-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217170-001 DOXYCYCLINE 40MG CAPSULE / ORAL AB 2024-07-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217170-001 DOXYCYCLINE 40MG CAPSULE / ORAL AB 2024-07-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217170-001 DOXYCYCLINE 40MG CAPSULE / ORAL AB 2024-07-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217170-001 DOXYCYCLINE 40MG CAPSULE / ORAL AB 2024-07-11 79d66fd596c7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217170-001 DOXYCYCLINE 40MG CAPSULE / ORAL AB 2024-07-11 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Doxycycline
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOXYCYCLINE 40 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60505-4775-3 Doxycycline 30 in 1 BOTTLE CAPSULE 30 4 60505-4775-5 Doxycycline 500 in 1 BOTTLE CAPSULE 500 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-4775 DOXYCYCLINE CAPSULE [APOTEX CORP.] 2 Current NDC, 2 package rows 20241102_7fb99e0c-10f6-2924-7940-84e52e7e2a36.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 60505-4775-3 60505477503 30 CAPSULE in 1 BOTTLE (60505-4775-3) 30 capsule 2024-10-31 No No Current 60505-4775-5 60505477505 500 in 1 BOTTLE Historical