Home NDC 33342-392 Doxycycline Hyclate
Product NDC 33342-392
11-digit product format 333420392
Labeler code 33342
Product ID 33342-392_2696f799-7902-4239-807a-9ae85a5d0f1d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxycycline Hyclate
Dosage form TABLET
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA211418
Marketing category ANDA
Marketing start 2025-11-19
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 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 A211418-001 DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2025-11-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211418-001 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 2026-02-19 14:30 UTC 2026-02 A211418-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2025-11-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211418-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2025-11-19 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211418-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2025-11-19 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 A211418-001 AB 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211418-001 AB 1 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211418-001 AB 1 a50c72e98297…
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 33342-392-05 Doxycycline Hyclate 20 in 1 BOTTLE TABLET 20 1 33342-392-08 Doxycycline Hyclate 50 in 1 BOTTLE TABLET 50 1 33342-392-11 Doxycycline Hyclate 100 in 1 BOTTLE TABLET 100 1 33342-392-12 Doxycycline Hyclate 10 in 1 BLISTER PACK TABLET 10 1 33342-392-12 Doxycycline Hyclate 10 in 1 CARTON TABLET 10 1 33342-392-15 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 · 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 33342-392-05 33342039205 20 TABLET in 1 BOTTLE (33342-392-05) 20 tablet 2025-11-19 No No Current 33342-392-08 33342039208 50 TABLET in 1 BOTTLE (33342-392-08) 50 tablet 2025-11-19 No No Current 33342-392-11 33342039211 100 TABLET in 1 BOTTLE (33342-392-11) 100 tablet 2025-11-19 No No Current 33342-392-12 33342039212 10 BLISTER PACK in 1 CARTON (33342-392-12) / 10 TABLET in 1 BLISTER PACK 10 blister pack 2025-11-19 No No Current 33342-392-15 33342039215 500 TABLET in 1 BOTTLE (33342-392-15) 500 tablet 2025-11-19 No No Current