Home NDC 53489-647 Doxycycline Hyclate
Product NDC 53489-647
11-digit product format 534890647
Labeler code 53489
Product ID 53489-647_31dd6775-5a9a-9e21-e063-6294a90aa546
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxycycline Hyclate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA065134
Marketing category ANDA
Marketing start 2005-05-13
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 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 A065134-001 DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2005-05-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065134-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A065134-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2005-05-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065134-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2005-05-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065134-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2005-05-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065134-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2005-05-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065134-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2005-05-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065134-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2005-05-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065134-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2005-05-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065134-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2005-05-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065134-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2005-05-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065134-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2005-05-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065134-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2005-05-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065134-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2005-05-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065134-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2005-05-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065134-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2005-05-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065134-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2005-05-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065134-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2005-05-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065134-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2005-05-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065134-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2005-05-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065134-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2005-05-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065134-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2005-05-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065134-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2005-05-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065134-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2005-05-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065134-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2005-05-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065134-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2005-05-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065134-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2005-05-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065134-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2005-05-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065134-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2005-05-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065134-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2005-05-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065134-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2005-05-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065134-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2005-05-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065134-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2005-05-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065134-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2005-05-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065134-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2005-05-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065134-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2005-05-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065134-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2005-05-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065134-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2005-05-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065134-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2005-05-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065134-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2005-05-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065134-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2005-05-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A065134-001 DOXYCYCLINE HYCLATE EQ 20MG BASE TABLET / ORAL AB 2005-05-13 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 53489-647-01 Doxycycline Hyclate 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 8 53489-647-03 Doxycycline Hyclate 250 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 250 8 53489-647-05 Doxycycline Hyclate 500 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 500 8 53489-647-06 Doxycycline Hyclate 60 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 60 8 53489-647-07 Doxycycline Hyclate 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 8 53489-647-10 Doxycycline Hyclate 1000 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 1000 8 53489-647-90 Doxycycline Hyclate 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Doxycycline Hyclate ACTIVE INGREDIENT 19XTS3T51U DOXYCYCLINE HYCLATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 Doxycycline Hyclate ACTIVE INGREDIENT 19XTS3T51U DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] 3 Doxycycline Anhydrous ACTIVE MOIETY 334895S862 DOXYCYCLINE HYCLATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 Doxycycline Anhydrous ACTIVE MOIETY 334895S862 DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] 3 anhydrous lactose INACTIVE INGREDIENT 3SY5LH9PMK DOXYCYCLINE HYCLATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 anhydrous lactose INACTIVE INGREDIENT 3SY5LH9PMK DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] 3 carnauba wax INACTIVE INGREDIENT R12CBM0EIZ DOXYCYCLINE HYCLATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 carnauba wax INACTIVE INGREDIENT R12CBM0EIZ DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] 3 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U DOXYCYCLINE HYCLATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] 3 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] 3 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 DOXYCYCLINE HYCLATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO DOXYCYCLINE HYCLATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] 3 magnesium stearate INACTIVE INGREDIENT 70097M6I30 DOXYCYCLINE HYCLATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 magnesium stearate INACTIVE INGREDIENT 70097M6I30 DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] 3 polydextrose INACTIVE INGREDIENT VH2XOU12IE DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] 3 polydextrose INACTIVE INGREDIENT VH2XOU12IE DOXYCYCLINE HYCLATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] 3 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A DOXYCYCLINE HYCLATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP DOXYCYCLINE HYCLATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] 3 triacetin INACTIVE INGREDIENT XHX3C3X673 DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.] 3 triacetin INACTIVE INGREDIENT XHX3C3X673 DOXYCYCLINE HYCLATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53489-647 DOXYCYCLINE HYCLATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] 8 Current NDC, Legacy NDC, 7 package rows 20250406_bff3f426-44fc-4dbf-96df-df44011103e8.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 Marketing start Marketing end Sample Exclude flag Status 53489-647-01 53489064701 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-01) 2005-05-13 0000-00-00 No No Current 53489-647-03 53489064703 250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-03) 2005-05-13 0000-00-00 No No Current 53489-647-05 53489064705 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-05) 2005-05-13 0000-00-00 No No Current 53489-647-06 53489064706 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-06) 2005-05-13 0000-00-00 No No Current 53489-647-07 53489064707 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-07) 2005-05-13 0000-00-00 No No Current 53489-647-10 53489064710 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-10) 2005-05-13 0000-00-00 No No Current 53489-647-90 53489064790 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-90) 2005-05-13 0000-00-00 No No Current