Home NDC 70518-3363-0 Doxycycline
Product NDC 70518-3363
Requested package NDC 70518-3363-0
11-digit product format 705183363
Labeler code 70518
Product ID 70518-3363_497365ff-c7cd-6fd6-e063-6294a90a4d50
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxycycline hyclate
Dosage form TABLET, COATED
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA210664
Marketing category ANDA
Marketing start 2022-02-10
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 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 1 · 11 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…
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 A210664-001 DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2020-03-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210664-001 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 A210664-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2020-03-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210664-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2020-03-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210664-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2020-03-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210664-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2020-03-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210664-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2020-03-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210664-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2020-03-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210664-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2020-03-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210664-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2020-03-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210664-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2020-03-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210664-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2020-03-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210664-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2020-03-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210664-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2020-03-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210664-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2020-03-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210664-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2020-03-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210664-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2020-03-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210664-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2020-03-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210664-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2020-03-16 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A210664-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2020-03-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210664-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2020-03-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210664-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2020-03-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210664-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2020-03-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210664-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2020-03-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210664-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2020-03-16 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210664-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2020-03-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210664-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2020-03-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210664-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2020-03-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210664-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2020-03-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210664-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2020-03-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210664-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2020-03-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210664-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2020-03-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210664-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2020-03-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210664-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2020-03-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210664-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2020-03-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210664-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2020-03-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210664-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2020-03-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210664-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2020-03-16 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210664-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2020-03-16 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Doxycycline
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 70518-3363-0 Doxycycline 14 in 1 BOTTLE, PLASTIC TABLET, COATED 14 5 70518-3363-1 Doxycycline 28 in 1 BOTTLE, PLASTIC TABLET, COATED 28 5
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 Marketing start Marketing end Sample Exclude flag Status 70518-3363-0 70518336300 14 TABLET, COATED in 1 BOTTLE, PLASTIC (70518-3363-0) 2022-02-10 0000-00-00 No No Current