Home NDC 64380-225 DOXYCYCLINE HYCLATE
Product NDC 64380-225
11-digit product format 643800225
Labeler code 64380
Product ID 64380-225_6c0d6056-c09d-4cd8-85a2-e9e2a96aa6fd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DOXYCYCLINE HYCLATE
Dosage form TABLET
Route ORAL
Labeler Strides Pharma Science Limited
Application ANDA062538
Marketing category ANDA
Marketing start 2026-05-14
Substance DOXYCYCLINE HYCLATE
Active strength 50 mg/1
Pharmacologic classes Tetracycline-class Drug [EPC]; Tetracyclines [CS]
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A062538-001 DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1986-04-07 A062538-002 DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 50MG BASE TABLET / ORAL AB 2025-11-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 2 · 44 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 A062538-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1986-04-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A062538-002 DOXYCYCLINE HYCLATE EQ 50MG BASE TABLET / ORAL AB 2025-11-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062538-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 1986-04-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062538-002 DOXYCYCLINE HYCLATE EQ 50MG BASE TABLET / ORAL AB 2025-11-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A062538-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 1986-04-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062538-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 1986-04-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062538-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 1986-04-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062538-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 1986-04-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062538-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 1986-04-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062538-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 1986-04-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062538-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 1986-04-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A062538-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 1986-04-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062538-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 1986-04-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062538-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 1986-04-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062538-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 1986-04-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A062538-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 1986-04-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062538-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 1986-04-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A062538-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 1986-04-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A062538-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 1986-04-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A062538-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 1986-04-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A062538-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 1986-04-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A062538-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 1986-04-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A062538-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 1986-04-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A062538-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 1986-04-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A062538-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 1986-04-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A062538-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 1986-04-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A062538-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 1986-04-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A062538-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 1986-04-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A062538-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 1986-04-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A062538-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 1986-04-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A062538-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 1986-04-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A062538-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 1986-04-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A062538-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 1986-04-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A062538-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 1986-04-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A062538-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 1986-04-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A062538-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 1986-04-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A062538-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 1986-04-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A062538-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 1986-04-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A062538-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 1986-04-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A062538-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 1986-04-07 f41ea6bd6efb…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base DOXYCYCLINE HYCLATE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOXYCYCLINE HYCLATE 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 19XTS3T51U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1652674 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64380-225-01 DOXYCYCLINE HYCLATE 60 in 1 BOTTLE TABLET 60 2
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 Sample Status 64380-225-01 64380022501 60 TABLET in 1 BOTTLE (64380-225-01) 60 tablet 2026-05-14 0 Current