Home NDC 0527-1335 Doxycycline
Product NDC 0527-1335
11-digit product format 005271335
Labeler code 0527
Product ID 0527-1335_dc960a6c-1b09-4049-a1e9-0109576b1d30
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxycycline
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Lannett Company, Inc.
Application ANDA065285
Marketing category ANDA
Marketing start 2005-12-08
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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065285-001 DOXYCYCLINE DOXYCYCLINE EQ 50MG BASE TABLET / ORAL AB 2005-12-08 A065285-002 DOXYCYCLINE DOXYCYCLINE EQ 100MG BASE TABLET / ORAL AB 2005-12-08 A065285-003 DOXYCYCLINE DOXYCYCLINE EQ 75MG BASE TABLET / ORAL AB 2008-07-30 A065285-004 DOXYCYCLINE DOXYCYCLINE EQ 150MG BASE TABLET / ORAL AB 2008-07-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 A065285-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL AB 2005-12-08 a50c72e98297…2026-08-01 22:54:32 2026-06 A065285-002 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL AB 2005-12-08 a50c72e98297…2026-08-01 22:54:32 2026-06 A065285-003 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL AB 2008-07-30 a50c72e98297…2026-08-01 22:54:32 2026-06 A065285-004 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL AB 2008-07-30 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 3 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1649429 Internal RxNorm lookup 1650142 Internal RxNorm lookup 1650444 Internal RxNorm lookup 1652673 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0527-1335-01 Doxycycline 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 28
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DOXYCYCLINE ACTIVE INGREDIENT N12000U13O DOXYCYCLINE TABLET, FILM COATED [LANNETT COMPANY, INC.] 14 DOXYCYCLINE ANHYDROUS ACTIVE MOIETY 334895S862 DOXYCYCLINE TABLET, FILM COATED [LANNETT COMPANY, INC.] 14 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 DOXYCYCLINE TABLET, FILM COATED [LANNETT COMPANY, INC.] 14 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK DOXYCYCLINE TABLET, FILM COATED [LANNETT COMPANY, INC.] 14 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DOXYCYCLINE TABLET, FILM COATED [LANNETT COMPANY, INC.] 14 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G DOXYCYCLINE TABLET, FILM COATED [LANNETT COMPANY, INC.] 14 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 DOXYCYCLINE TABLET, FILM COATED [LANNETT COMPANY, INC.] 14 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DOXYCYCLINE TABLET, FILM COATED [LANNETT COMPANY, INC.] 14 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A DOXYCYCLINE TABLET, FILM COATED [LANNETT COMPANY, INC.] 14 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 DOXYCYCLINE TABLET, FILM COATED [LANNETT COMPANY, INC.] 14 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 DOXYCYCLINE TABLET, FILM COATED [LANNETT COMPANY, INC.] 14 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ DOXYCYCLINE TABLET, FILM COATED [LANNETT COMPANY, INC.] 14 TALC INACTIVE INGREDIENT 7SEV7J4R1U DOXYCYCLINE TABLET, FILM COATED [LANNETT COMPANY, INC.] 14 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DOXYCYCLINE TABLET, FILM COATED [LANNETT COMPANY, INC.] 14 DOXYCYCLINE ACTIVE INGREDIENT N12000U13O DOXYCYCLINE TABLET, FILM COATED [DIRECTRX] 1 DOXYCYCLINE ANHYDROUS ACTIVE MOIETY 334895S862 DOXYCYCLINE TABLET, FILM COATED [DIRECTRX] 1 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 DOXYCYCLINE TABLET, FILM COATED [DIRECTRX] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK DOXYCYCLINE TABLET, FILM COATED [DIRECTRX] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DOXYCYCLINE TABLET, FILM COATED [DIRECTRX] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G DOXYCYCLINE TABLET, FILM COATED [DIRECTRX] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 DOXYCYCLINE TABLET, FILM COATED [DIRECTRX] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DOXYCYCLINE TABLET, FILM COATED [DIRECTRX] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A DOXYCYCLINE TABLET, FILM COATED [DIRECTRX] 1 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 DOXYCYCLINE TABLET, FILM COATED [DIRECTRX] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 DOXYCYCLINE TABLET, FILM COATED [DIRECTRX] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ DOXYCYCLINE TABLET, FILM COATED [DIRECTRX] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U DOXYCYCLINE TABLET, FILM COATED [DIRECTRX] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DOXYCYCLINE TABLET, FILM COATED [DIRECTRX] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0527-1335 DOXYCYCLINE TABLET, FILM COATED [LANNETT COMPANY, INC.] 28 Current NDC, Legacy NDC, 1 package rows 20240704_4999bbd9-44ed-4749-9730-be2337bdf490.zip
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 0527-1335-01 00527133501 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-1335-01) 2005-12-08 0000-00-00 No No Current