Home NDC 68047-714 Doxycycline Hyclate
Product NDC 68047-714
11-digit product format 680470714
Labeler code 68047
Product ID 68047-714_3b3e9b64-b623-f126-e063-6394a90a90c3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxycycline Hyclate
Dosage form TABLET
Route ORAL
Labeler Larken Laboratories, Inc.
Application ANDA065287
Marketing category ANDA
Marketing start 2010-11-15
Substance DOXYCYCLINE HYCLATE
Active strength 20 mg/1
Pharmacologic classes Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A065287-001 DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2006-02-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065287-001 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 · 42 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 2026-08-18 06:07:40 2026-07 A065287-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2006-02-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065287-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2006-02-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065287-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2006-02-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065287-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2006-02-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065287-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2006-02-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065287-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2006-02-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065287-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2006-02-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065287-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2006-02-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065287-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2006-02-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065287-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2006-02-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065287-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2006-02-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065287-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2006-02-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065287-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2006-02-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065287-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2006-02-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065287-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2006-02-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065287-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2006-02-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065287-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2006-02-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065287-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2006-02-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065287-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2006-02-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065287-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2006-02-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065287-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2006-02-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065287-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2006-02-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065287-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2006-02-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065287-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2006-02-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065287-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2006-02-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065287-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2006-02-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065287-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2006-02-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065287-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2006-02-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065287-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2006-02-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065287-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2006-02-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065287-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2006-02-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065287-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2006-02-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065287-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2006-02-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065287-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2006-02-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065287-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2006-02-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065287-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2006-02-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065287-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2006-02-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065287-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2006-02-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065287-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2006-02-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065287-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2006-02-28 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Doxycycline Hyclate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOXYCYCLINE HYCLATE 20 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 283535 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 68047-714-01 Doxycycline Hyclate 100 in 1 BOTTLE TABLET 100 14 68047-714-60 Doxycycline Hyclate 60 in 1 BOTTLE TABLET 60 14
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DOXYCYCLINE HYCLATE ACTIVE INGREDIENT 19XTS3T51U DOXYCYCLINE HYCLATE TABLET [LARKEN LABORATORIES, INC.] 1 DOXYCYCLINE ACTIVE MOIETY N12000U13O DOXYCYCLINE HYCLATE TABLET [LARKEN LABORATORIES, INC.] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK DOXYCYCLINE HYCLATE TABLET [LARKEN LABORATORIES, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DOXYCYCLINE HYCLATE TABLET [LARKEN LABORATORIES, INC.] 1 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 DOXYCYCLINE HYCLATE TABLET [LARKEN LABORATORIES, INC.] 1 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 DOXYCYCLINE HYCLATE TABLET [LARKEN LABORATORIES, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DOXYCYCLINE HYCLATE TABLET [LARKEN LABORATORIES, INC.] 1 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ DOXYCYCLINE HYCLATE TABLET [LARKEN LABORATORIES, INC.] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H DOXYCYCLINE HYCLATE TABLET [LARKEN LABORATORIES, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 DOXYCYCLINE HYCLATE TABLET [LARKEN LABORATORIES, INC.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 DOXYCYCLINE HYCLATE TABLET [LARKEN LABORATORIES, INC.] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U DOXYCYCLINE HYCLATE TABLET [LARKEN LABORATORIES, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DOXYCYCLINE HYCLATE TABLET [LARKEN LABORATORIES, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68047-714 DOXYCYCLINE HYCLATE TABLET [LARKEN LABORATORIES, INC.] 13 Current NDC, Legacy NDC, 2 package rows 20241012_49f82130-6f8a-412c-b625-e75906e74675.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68047-714-01 68047071401 100 TABLET in 1 BOTTLE (68047-714-01) 100 tablet 2010-11-15 0000-00-00 No No Current 68047-714-60 68047071460 60 TABLET in 1 BOTTLE (68047-714-60) 60 tablet 2010-11-15 0000-00-00 No No Current