Home NDC 71335-0861 Doxycycline Hyclate
Product NDC 71335-0861
11-digit product format 713350861
Labeler code 71335
Product ID 71335-0861_16d62b1d-92db-4cac-bda3-ecd5f808ce37
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxycycline
Dosage form CAPSULE
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA207289
Marketing category ANDA
Marketing start 2016-06-28
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 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 · 22 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A207289-001 DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE / ORAL AB 2016-06-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207289-001 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 A207289-001 DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE / ORAL AB 2016-06-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207289-001 DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE / ORAL AB 2016-06-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207289-001 DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE / ORAL AB 2016-06-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207289-001 DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE / ORAL AB 2016-06-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207289-001 DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE / ORAL AB 2016-06-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207289-001 DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE / ORAL AB 2016-06-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207289-001 DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE / ORAL AB 2016-06-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207289-001 DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE / ORAL AB 2016-06-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207289-001 DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE / ORAL AB 2016-06-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207289-001 DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE / ORAL AB 2016-06-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207289-001 DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE / ORAL AB 2016-06-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207289-001 DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE / ORAL AB 2016-06-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207289-001 DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE / ORAL AB 2016-06-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207289-001 DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE / ORAL AB 2016-06-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207289-001 DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE / ORAL AB 2016-06-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207289-001 DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE / ORAL AB 2016-06-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207289-001 DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE / ORAL AB 2016-06-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207289-001 DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE / ORAL AB 2016-06-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207289-001 DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE / ORAL AB 2016-06-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207289-001 DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE / ORAL AB 2016-06-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207289-001 DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE / ORAL AB 2016-06-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207289-001 DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE / ORAL AB 2016-06-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207289-001 DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE / ORAL AB 2016-06-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207289-001 DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE / ORAL AB 2016-06-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207289-001 DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE / ORAL AB 2016-06-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207289-001 DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE / ORAL AB 2016-06-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207289-001 DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE / ORAL AB 2016-06-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207289-001 DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE / ORAL AB 2016-06-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207289-001 DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE / ORAL AB 2016-06-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207289-001 DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE / ORAL AB 2016-06-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207289-001 DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE / ORAL AB 2016-06-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207289-001 DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE / ORAL AB 2016-06-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207289-001 DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE / ORAL AB 2016-06-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207289-001 DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE / ORAL AB 2016-06-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207289-001 DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE / ORAL AB 2016-06-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207289-001 DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE / ORAL AB 2016-06-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207289-001 DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE / ORAL AB 2016-06-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207289-001 DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE / ORAL AB 2016-06-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207289-001 DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE / ORAL AB 2016-06-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A207289-001 DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE / ORAL AB 2016-06-27 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 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 1649988 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 71335-0861-0 2024-05-16 Doxycycline Hyclate Capsules, USP (100 mg) Rx Only 71335-0861-1 2024-05-16 Doxycycline Hyclate Capsules, USP (100 mg) Rx Only 71335-0861-2 2024-05-16 Doxycycline Hyclate Capsules, USP (100 mg) Rx Only 71335-0861-3 2024-05-16 Doxycycline Hyclate Capsules, USP (100 mg) Rx Only 71335-0861-4 2024-05-16 Doxycycline Hyclate Capsules, USP (100 mg) Rx Only 71335-0861-5 2024-05-16 Doxycycline Hyclate Capsules, USP (100 mg) Rx Only 71335-0861-6 2024-05-16 Doxycycline Hyclate Capsules, USP (100 mg) Rx Only 71335-0861-7 2024-05-16 Doxycycline Hyclate Capsules, USP (100 mg) Rx Only 71335-0861-8 2024-05-16 Doxycycline Hyclate Capsules, USP (100 mg) Rx Only 71335-0861-9 2024-05-16 Doxycycline Hyclate Capsules, USP (100 mg) Rx Only 71335-0861-0 2024-01-30 Doxycycline Hyclate Capsules, USP (100 mg) Rx Only 71335-0861-1 2024-01-30 Doxycycline Hyclate Capsules, USP (100 mg) Rx Only 71335-0861-2 2024-01-30 Doxycycline Hyclate Capsules, USP (100 mg) Rx Only 71335-0861-3 2024-01-30 Doxycycline Hyclate Capsules, USP (100 mg) Rx Only 71335-0861-4 2024-01-30 Doxycycline Hyclate Capsules, USP (100 mg) Rx Only 71335-0861-5 2024-01-30 Doxycycline Hyclate Capsules, USP (100 mg) Rx Only 71335-0861-6 2024-01-30 Doxycycline Hyclate Capsules, USP (100 mg) Rx Only 71335-0861-7 2024-01-30 Doxycycline Hyclate Capsules, USP (100 mg) Rx Only 71335-0861-8 2024-01-30 Doxycycline Hyclate Capsules, USP (100 mg) Rx Only 71335-0861-9 2024-01-30 Doxycycline Hyclate Capsules, USP (100 mg) Rx Only
DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-0861 DOXYCYCLINE HYCLATE (DOXYCYCLINE) CAPSULE [BRYANT RANCH PREPACK] 5 Current NDC, Legacy NDC, 10 package rows 20240517_f9a9a558-4063-4aa7-9191-3875c97cf49a.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 · 5 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 71335-0861-0 71335086100 6 CAPSULE in 1 BOTTLE (71335-0861-0) 6 capsule 2018-09-24 0000-00-00 No No Current 71335-0861-1 71335086101 10 CAPSULE in 1 BOTTLE (71335-0861-1) 10 capsule 2021-12-27 0000-00-00 No No Current 71335-0861-2 71335086102 20 CAPSULE in 1 BOTTLE (71335-0861-2) 20 capsule 2018-06-18 0000-00-00 No No Current 71335-0861-3 71335086103 30 CAPSULE in 1 BOTTLE (71335-0861-3) 30 capsule 2018-06-13 0000-00-00 No No Current 71335-0861-4 71335086104 40 CAPSULE in 1 BOTTLE (71335-0861-4) 40 capsule 2021-12-27 0000-00-00 No No Current 71335-0861-5 71335086105 60 CAPSULE in 1 BOTTLE (71335-0861-5) 60 capsule 2018-09-26 0000-00-00 No No Current 71335-0861-6 71335086106 28 CAPSULE in 1 BOTTLE (71335-0861-6) 28 capsule 2018-10-03 0000-00-00 No No Current 71335-0861-7 71335086107 14 CAPSULE in 1 BOTTLE (71335-0861-7) 14 capsule 2018-07-17 0000-00-00 No No Current 71335-0861-8 71335086108 90 CAPSULE in 1 BOTTLE (71335-0861-8) 90 capsule 2018-07-11 0000-00-00 No No Current 71335-0861-9 71335086109 365 CAPSULE in 1 BOTTLE (71335-0861-9) 365 capsule 2021-12-27 0000-00-00 No No Current