Home NDC 43386-794 Doxycycline Hyclate
Product NDC 43386-794
11-digit product format 433860794
Labeler code 43386
Product ID 43386-794_21feab96-ff6a-4924-8dcb-becaf40d9356
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxycycline Hyclate
Dosage form TABLET
Route ORAL
Labeler Lupin Pharmaceuticals,Inc.
Application ANDA207558
Marketing category ANDA
Marketing start 2017-09-06
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A207558-001 DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2017-09-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207558-001 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 A207558-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2017-09-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207558-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2017-09-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207558-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2017-09-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207558-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2017-09-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207558-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2017-09-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207558-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2017-09-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207558-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2017-09-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207558-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2017-09-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207558-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2017-09-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207558-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2017-09-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207558-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2017-09-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207558-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2017-09-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207558-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2017-09-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207558-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2017-09-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207558-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2017-09-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207558-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2017-09-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207558-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2017-09-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207558-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2017-09-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207558-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2017-09-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207558-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2017-09-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207558-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2017-09-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207558-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2017-09-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207558-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2017-09-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207558-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2017-09-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207558-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2017-09-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207558-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2017-09-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207558-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2017-09-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207558-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2017-09-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207558-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2017-09-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207558-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2017-09-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207558-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2017-09-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207558-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2017-09-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207558-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2017-09-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207558-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2017-09-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207558-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2017-09-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207558-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2017-09-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207558-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2017-09-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207558-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2017-09-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207558-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2017-09-06 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A207558-001 DOXYCYCLINE HYCLATE EQ 100MG BASE TABLET / ORAL AB 2017-09-06 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 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 43386-794-01 Doxycycline Hyclate 100 in 1 BOTTLE TABLET 100 4 43386-794-02 Doxycycline Hyclate 20 in 1 BOTTLE TABLET 20 4 43386-794-05 Doxycycline Hyclate 500 in 1 BOTTLE TABLET 500 4 43386-794-10 Doxycycline Hyclate 1000 in 1 BOTTLE TABLET 1000 4 43386-794-50 Doxycycline Hyclate 50 in 1 BOTTLE TABLET 50 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43386-794 DOXYCYCLINE HYCLATE TABLET [LUPIN PHARMACEUTICALS,INC.] 4 Current NDC, Legacy NDC, 5 package rows 20240131_b752ea66-3144-4f78-96fe-a5f4d92740a7.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 Units Marketing start Marketing end Sample Exclude flag Status 43386-794-01 43386079401 100 TABLET in 1 BOTTLE (43386-794-01) 100 tablet 2017-09-06 0000-00-00 No No Current 43386-794-02 43386079402 20 TABLET in 1 BOTTLE (43386-794-02) 20 tablet 2017-09-06 0000-00-00 No No Current 43386-794-05 43386079405 500 TABLET in 1 BOTTLE (43386-794-05) 500 tablet 2017-09-06 0000-00-00 No No Current 43386-794-10 43386079410 1000 TABLET in 1 BOTTLE (43386-794-10) 1000 tablet 2018-02-13 0000-00-00 No No Current 43386-794-50 43386079450 50 TABLET in 1 BOTTLE (43386-794-50) 50 tablet 2017-09-06 0000-00-00 No No Current