Home NDC 0440-7482 Doxycycline Hyclate
Product NDC 0440-7482
11-digit product format 004407482
Labeler code 0440
Product ID 0440-7482_a26216f9-5683-4404-8e92-9ccacb952695
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxycycline Hyclate
Dosage form TABLET
Route ORAL
Labeler Liberty Pharmaceuticals, Inc.
Application ANDA062421
Marketing category ANDA
Marketing start 1983-02-02
Marketing end 0000-00-00
Substance DOXYCYCLINE HYCLATE
Active strength 100 mg/1
Pharmacologic classes Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag E
Listing certified through 2018-12-31
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 2 · 66 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A062421-001 DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A062421-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A062421-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1983-02-02 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2022-09-29 23:25 UTC 2022-09 A062421-001 AB 1 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A062421-001 AB 1 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A062421-001 AB 1 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 0440-7482-20 Doxycycline Hyclate 20 in 1 BOTTLE TABLET 20 1 0440-7482-91 Doxycycline Hyclate 120 in 1 BOTTLE TABLET 120 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0440-7482 DOXYCYCLINE HYCLATE TABLET [LIBERTY PHARMACEUTICALS, INC.] 1 Legacy NDC, 2 package rows 20160810_4dbf2821-c502-4dcd-a0a1-603ae95a4335.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 0440-7482-20 00440748220 20 in 1 BOTTLE Historical 0440-7482-91 00440748291 120 in 1 BOTTLE Historical