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 42 .
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.
Product history page 1 of 5 · 168 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 A065285-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL AB 2005-12-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065285-002 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL AB 2005-12-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065285-003 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL AB 2008-07-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065285-004 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL AB 2008-07-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065285-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL AB 2005-12-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065285-002 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL AB 2005-12-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065285-003 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL AB 2008-07-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065285-004 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL AB 2008-07-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065285-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL AB 2005-12-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065285-002 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL AB 2005-12-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065285-003 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL AB 2008-07-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065285-004 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL AB 2008-07-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065285-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL AB 2005-12-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065285-002 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL AB 2005-12-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065285-003 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL AB 2008-07-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065285-004 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL AB 2008-07-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065285-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL AB 2005-12-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065285-002 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL AB 2005-12-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065285-003 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL AB 2008-07-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065285-004 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL AB 2008-07-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065285-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL AB 2005-12-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065285-002 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL AB 2005-12-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065285-003 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL AB 2008-07-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065285-004 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL AB 2008-07-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065285-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL AB 2005-12-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065285-002 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL AB 2005-12-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065285-003 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL AB 2008-07-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065285-004 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL AB 2008-07-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065285-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL AB 2005-12-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065285-002 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL AB 2005-12-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065285-003 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL AB 2008-07-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065285-004 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL AB 2008-07-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065285-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL AB 2005-12-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065285-002 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL AB 2005-12-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065285-003 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL AB 2008-07-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065285-004 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL AB 2008-07-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065285-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL AB 2005-12-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065285-002 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL AB 2005-12-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065285-003 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL AB 2008-07-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065285-004 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL AB 2008-07-30 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 168 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 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
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 · 3 matching rows.
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