Home NDC 43386-792 Doxycycline
Product NDC 43386-792
11-digit product format 433860792
Labeler code 43386
Product ID 43386-792_a3ed2ee4-163c-4167-abf2-59a7e1d66a61
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name doxycycline
Dosage form CAPSULE
Route ORAL
Labeler Lupin Pharmaceuticals,Inc.
Application ANDA204446
Marketing category ANDA
Marketing start 2015-07-08
Substance DOXYCYCLINE
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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Dataset, Scope, Package NDC table Dataset Scope Package NDC excluded product product excluded package package 43386-792-02 excluded package package 43386-792-11 excluded package package 43386-792-10
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204446-001 DOXYCYCLINE DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL 2015-05-28 A204446-002 DOXYCYCLINE DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL 2015-05-28 A204446-003 DOXYCYCLINE DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL 2015-05-28
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 4 · 126 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 A204446-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL 2015-05-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204446-002 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL 2015-05-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204446-003 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL 2015-05-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204446-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL 2015-05-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204446-002 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL 2015-05-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204446-003 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL 2015-05-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204446-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL 2015-05-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204446-002 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL 2015-05-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204446-003 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL 2015-05-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204446-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL 2015-05-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204446-002 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL 2015-05-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204446-003 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL 2015-05-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204446-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL 2015-05-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204446-002 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL 2015-05-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204446-003 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL 2015-05-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204446-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL 2015-05-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204446-002 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL 2015-05-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204446-003 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL 2015-05-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204446-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL 2015-05-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204446-002 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL 2015-05-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204446-003 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL 2015-05-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204446-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL 2015-05-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204446-002 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL 2015-05-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204446-003 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL 2015-05-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204446-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL 2015-05-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204446-002 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL 2015-05-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204446-003 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL 2015-05-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204446-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL 2015-05-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204446-002 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL 2015-05-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204446-003 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL 2015-05-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204446-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL 2015-05-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204446-002 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL 2015-05-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204446-003 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL 2015-05-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204446-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL 2015-05-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204446-002 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL 2015-05-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204446-003 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL 2015-05-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204446-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL 2015-05-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204446-002 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL 2015-05-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204446-003 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL 2015-05-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204446-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL 2015-05-28 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 78 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Doxycycline
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOXYCYCLINE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination N12000U13O Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 700408 Internal RxNorm lookup 1649401 Internal RxNorm lookup 1649990 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 43386-792-02 Doxycycline 250 in 1 BOTTLE CAPSULE 250 4 43386-792-10 Doxycycline 1000 in 1 BOTTLE CAPSULE 1000 4 43386-792-11 Doxycycline 50 in 1 BOTTLE CAPSULE 50 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DOXYCYCLINE ACTIVE INGREDIENT N12000U13O DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC] 1 DOXYCYCLINE ANHYDROUS ACTIVE MOIETY 334895S862 DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC] 1 FD&C RED NO. 3 INACTIVE INGREDIENT PN2ZH5LOQY DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC] 1 POTASSIUM HYDROXIDE INACTIVE INGREDIENT WZH3C48M4T DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43386-792 DOXYCYCLINE CAPSULE [LUPIN PHARMACEUTICALS,INC.] 4 Current NDC, Legacy NDC, 3 package rows 20240131_6512bf22-c211-4127-a8c8-2419656580f6.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 43386-792-02 43386079202 250 CAPSULE in 1 BOTTLE (43386-792-02) 250 capsule 2015-07-08 0000-00-00 No No Current 43386-792-10 43386079210 1000 CAPSULE in 1 BOTTLE (43386-792-10) 1000 capsule 2015-07-08 0000-00-00 No No Current 43386-792-11 43386079211 50 CAPSULE in 1 BOTTLE (43386-792-11) 50 capsule 2015-07-08 0000-00-00 No No Current