Home NDC 43386-790 Doxycycline
Product NDC 43386-790
11-digit product format 433860790
Labeler code 43386
Product ID 43386-790_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 50 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 · 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.
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 2026-08-01 22:54:32 2026-06 A204446-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL 2015-05-28 a50c72e98297…2026-08-01 22:54:32 2026-06 A204446-002 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL 2015-05-28 a50c72e98297…2026-08-01 22:54:32 2026-06 A204446-003 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL 2015-05-28 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Doxycycline
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOXYCYCLINE 50 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 43386-790-01 Doxycycline 100 in 1 BOTTLE CAPSULE 100 4 43386-790-10 Doxycycline 1000 in 1 BOTTLE CAPSULE 1000 4 43386-790-11 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 43386-790 DOXYCYCLINE CAPSULE [LUPIN PHARMACEUTICALS,INC.] 4 Current NDC, Legacy NDC, 3 package rows 20240131_6512bf22-c211-4127-a8c8-2419656580f6.zip
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 43386-790-01 43386079001 100 CAPSULE in 1 BOTTLE (43386-790-01) 100 capsule 2015-07-08 0000-00-00 No No Current 43386-790-10 43386079010 1000 CAPSULE in 1 BOTTLE (43386-790-10) 1000 capsule 2015-07-08 0000-00-00 No No Current 43386-790-11 43386079011 50 CAPSULE in 1 BOTTLE (43386-790-11) 50 capsule 2015-07-08 0000-00-00 No No Current