Home NDC 46708-353 Doxycycline Hyclate
Product NDC 46708-353
11-digit product format 467080353
Labeler code 46708
Product ID 46708-353_8a6d5c0f-9b8e-444e-882e-8a2264410c02
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxycycline Hyclate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Alembic Pharmaceuticals Limited
Application ANDA210536
Marketing category ANDA
Marketing start 2020-05-15
Substance DOXYCYCLINE HYCLATE
Active strength 100 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210536-001 DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2020-05-14 A210536-002 DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 50MG BASE TABLET / ORAL AB 2021-09-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210536-002 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 · 70 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 A210536-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2020-05-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210536-002 DOXYCYCLINE HYCLATE EQ 50MG BASE TABLET / ORAL AB 2021-09-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210536-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2020-05-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210536-002 DOXYCYCLINE HYCLATE EQ 50MG BASE TABLET / ORAL AB 2021-09-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210536-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2020-05-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210536-002 DOXYCYCLINE HYCLATE EQ 50MG BASE TABLET / ORAL AB 2021-09-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210536-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2020-05-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210536-002 DOXYCYCLINE HYCLATE EQ 50MG BASE TABLET / ORAL AB 2021-09-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210536-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2020-05-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210536-002 DOXYCYCLINE HYCLATE EQ 50MG BASE TABLET / ORAL AB 2021-09-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210536-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2020-05-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210536-002 DOXYCYCLINE HYCLATE EQ 50MG BASE TABLET / ORAL AB 2021-09-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210536-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2020-05-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210536-002 DOXYCYCLINE HYCLATE EQ 50MG BASE TABLET / ORAL AB 2021-09-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210536-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2020-05-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210536-002 DOXYCYCLINE HYCLATE EQ 50MG BASE TABLET / ORAL AB 2021-09-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210536-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2020-05-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210536-002 DOXYCYCLINE HYCLATE EQ 50MG BASE TABLET / ORAL AB 2021-09-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210536-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2020-05-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210536-002 DOXYCYCLINE HYCLATE EQ 50MG BASE TABLET / ORAL AB 2021-09-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210536-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2020-05-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210536-002 DOXYCYCLINE HYCLATE EQ 50MG BASE TABLET / ORAL AB 2021-09-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210536-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2020-05-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210536-002 DOXYCYCLINE HYCLATE EQ 50MG BASE TABLET / ORAL AB 2021-09-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210536-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2020-05-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210536-002 DOXYCYCLINE HYCLATE EQ 50MG BASE TABLET / ORAL AB 2021-09-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210536-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2020-05-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A210536-002 DOXYCYCLINE HYCLATE EQ 50MG BASE TABLET / ORAL AB 2021-09-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210536-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2020-05-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210536-002 DOXYCYCLINE HYCLATE EQ 50MG BASE TABLET / ORAL AB 2021-09-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210536-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2020-05-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A210536-002 DOXYCYCLINE HYCLATE EQ 50MG BASE TABLET / ORAL AB 2021-09-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210536-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2020-05-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A210536-002 DOXYCYCLINE HYCLATE EQ 50MG BASE TABLET / ORAL AB 2021-09-14 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A210536-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2020-05-14 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A210536-002 DOXYCYCLINE HYCLATE EQ 50MG BASE TABLET / ORAL AB 2021-09-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210536-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2020-05-14 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A210536-002 DOXYCYCLINE HYCLATE EQ 50MG BASE TABLET / ORAL AB 2021-09-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210536-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2020-05-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210536-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL 2020-05-14 5aa47cf7b7d7…
Observed Orange Book normalized TE history# 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 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1650143 Internal RxNorm lookup 1652674 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 46708-353-20 2023-02-01 Doxycycline Hyclate Tablets, USP Rx only To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate tablets, USP and other antibacterial drugs, doxycycline hyclate tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 46708-353-50 2023-02-01 Doxycycline Hyclate Tablets, USP Rx only To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate tablets, USP and other antibacterial drugs, doxycycline hyclate tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 46708-353-71 2023-02-01 Doxycycline Hyclate Tablets, USP Rx only To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate tablets, USP and other antibacterial drugs, doxycycline hyclate tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 46708-353-20 2023-01-30 Doxycycline Hyclate Tablets, USP Rx only To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate tablets, USP and other antibacterial drugs, doxycycline hyclate tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 46708-353-50 2023-01-30 Doxycycline Hyclate Tablets, USP Rx only To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate tablets, USP and other antibacterial drugs, doxycycline hyclate tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 46708-353-71 2023-01-30 Doxycycline Hyclate Tablets, USP Rx only To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate tablets, USP and other antibacterial drugs, doxycycline hyclate tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 46708-353-20 Doxycycline Hyclate 20 in 1 BOTTLE TABLET, FILM COATED 20 3 46708-353-50 Doxycycline Hyclate 50 in 1 BOTTLE TABLET, FILM COATED 50 3 46708-353-71 Doxycycline Hyclate 500 in 1 BOTTLE TABLET, FILM COATED 500 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46708-353 DOXYCYCLINE HYCLATE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] 3 Current NDC, Legacy NDC, 3 package rows 20230202_24c8472a-dd07-4f84-8bea-20a3f178d119.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 46708-353-20 46708035320 20 TABLET, FILM COATED in 1 BOTTLE (46708-353-20) 2020-05-15 0000-00-00 No No Current 46708-353-50 46708035350 50 TABLET, FILM COATED in 1 BOTTLE (46708-353-50) 2020-05-15 0000-00-00 No No Current 46708-353-71 46708035371 500 TABLET, FILM COATED in 1 BOTTLE (46708-353-71) 2020-05-15 0000-00-00 No No Current