Home NDC 64380-226 DOXYCYCLINE HYCLATE
Product NDC 64380-226
11-digit product format 643800226
Labeler code 64380
Product ID 64380-226_b2280179-ad01-4227-bf4d-bc5bfd107889
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 100 mg/1
Pharmacologic classes Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 48 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 A062538-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1986-04-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A062538-002 DOXYCYCLINE HYCLATE EQ 50MG BASE TABLET / ORAL AB 2025-11-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A062538-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 1986-04-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A062538-002 DOXYCYCLINE HYCLATE EQ 50MG BASE TABLET / ORAL AB 2025-11-24 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 100 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 1650143 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 64380-226-01 DOXYCYCLINE HYCLATE 50 in 1 BOTTLE TABLET 50 1 64380-226-02 DOXYCYCLINE HYCLATE 500 in 1 BOTTLE TABLET 500 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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 64380-226-01 64380022601 50 in 1 BOTTLE Historical 64380-226-02 64380022602 500 TABLET in 1 BOTTLE (64380-226-02) 500 tablet 2026-05-14 No No Current