Home NDC 82804-173 Doxycycline Hyclate
Product NDC 82804-173
11-digit product format 828040173
Labeler code 82804
Product ID 82804-173_9f066753-55e4-4cf7-b4ec-225170fec1cb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxycycline Hyclate
Dosage form TABLET
Route ORAL
Labeler Proficient Rx LP
Application ANDA062421
Marketing category ANDA
Marketing start 1990-01-01
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 · 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 1 of 2 · 43 observed states.
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 82804-173-14 Doxycycline Hyclate 14 in 1 BOTTLE, PLASTIC TABLET 14 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82804-173 DOXYCYCLINE HYCLATE TABLET [PROFICIENT RX LP] 2 Current NDC, 1 package rows 20250112_19d93cd3-6ac6-4e5d-8e7e-1a48799df3cf.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 Units Marketing start Sample Exclude flag Status 82804-173-14 82804017314 14 TABLET in 1 BOTTLE, PLASTIC (82804-173-14) 14 tablet 2024-12-12 No No Current