Home NDC 63304-173 Doxycycline
Product NDC 63304-173
11-digit product format 633040173
Labeler code 63304
Product ID 63304-173_fd417a50-69b5-40b4-89fd-58aea77ab547
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxycycline
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sun Pharmaceutical Industries Inc.
Application ANDA065356
Marketing category ANDA
Marketing start 2018-08-06
Substance DOXYCYCLINE
Active strength 150 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 43 .
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 A065356-001 DOXYCYCLINE DOXYCYCLINE EQ 50MG BASE TABLET / ORAL AB 2006-05-31 A065356-002 DOXYCYCLINE DOXYCYCLINE EQ 75MG BASE TABLET / ORAL AB 2006-05-31 A065356-003 DOXYCYCLINE DOXYCYCLINE EQ 100MG BASE TABLET / ORAL AB 2006-05-31 A065356-004 DOXYCYCLINE DOXYCYCLINE EQ 150MG BASE TABLET / ORAL AB 2010-07-29
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 · 172 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 2026-09-14 22:38:34 2026-08 A065356-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL AB 2006-05-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A065356-002 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL AB 2006-05-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A065356-003 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL AB 2006-05-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A065356-004 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL AB 2010-07-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A065356-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL AB 2006-05-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065356-002 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL AB 2006-05-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065356-003 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL AB 2006-05-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065356-004 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL AB 2010-07-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065356-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL AB 2006-05-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065356-002 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL AB 2006-05-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065356-003 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL AB 2006-05-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065356-004 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL AB 2010-07-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065356-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL AB 2006-05-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065356-002 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL AB 2006-05-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065356-003 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL AB 2006-05-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065356-004 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL AB 2010-07-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065356-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL AB 2006-05-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065356-002 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL AB 2006-05-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065356-003 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL AB 2006-05-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065356-004 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL AB 2010-07-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065356-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL AB 2006-05-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065356-002 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL AB 2006-05-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065356-003 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL AB 2006-05-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065356-004 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL AB 2010-07-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065356-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL AB 2006-05-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065356-002 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL AB 2006-05-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065356-003 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL AB 2006-05-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065356-004 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL AB 2010-07-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065356-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL AB 2006-05-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065356-002 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL AB 2006-05-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065356-003 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL AB 2006-05-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065356-004 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL AB 2010-07-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065356-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL AB 2006-05-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065356-002 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL AB 2006-05-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065356-003 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL AB 2006-05-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065356-004 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL AB 2010-07-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065356-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL AB 2006-05-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065356-002 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL AB 2006-05-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065356-003 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL AB 2006-05-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065356-004 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL AB 2010-07-29 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 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 150 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63304-173-03 Doxycycline 10 in 1 BOTTLE TABLET, FILM COATED 10 5 63304-173-10 Doxycycline 1000 in 1 BOTTLE TABLET, FILM COATED 1000 5 63304-173-11 Doxycycline 10 in 1 BLISTER PACK TABLET, FILM COATED 10 5 63304-173-30 Doxycycline 30 in 1 BOTTLE TABLET, FILM COATED 30 5 63304-173-69 Doxycycline 1 in 1 CARTON TABLET, FILM COATED 1 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DOXYCYCLINE ACTIVE INGREDIENT N12000U13O DOXYCYCLINE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 3 DOXYCYCLINE ANHYDROUS ACTIVE MOIETY 334895S862 DOXYCYCLINE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DOXYCYCLINE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G DOXYCYCLINE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD DOXYCYCLINE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 3 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 DOXYCYCLINE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO DOXYCYCLINE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DOXYCYCLINE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A DOXYCYCLINE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 3 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H DOXYCYCLINE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 DOXYCYCLINE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 3 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 DOXYCYCLINE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DOXYCYCLINE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 3 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 DOXYCYCLINE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63304-173 DOXYCYCLINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES INC.] 5 Current NDC, Legacy NDC, 5 package rows 20180807_8224b9c5-5c4b-4dda-bc58-47b6604c2884.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 · 1 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 63304-173-03 63304017303 10 TABLET, FILM COATED in 1 BOTTLE (63304-173-03) 2018-08-06 0000-00-00 No No Current 63304-173-10 63304017310 1000 TABLET, FILM COATED in 1 BOTTLE (63304-173-10) 2018-08-06 0000-00-00 No No Current 63304-173-11 63304017311 10 in 1 BLISTER PACK Historical 63304-173-30 63304017330 30 TABLET, FILM COATED in 1 BOTTLE (63304-173-30) 2018-08-06 0000-00-00 No No Current 63304-173-69 63304017369 1 BLISTER PACK in 1 CARTON (63304-173-69) / 10 TABLET, FILM COATED in 1 BLISTER PACK (63304-173-11) 1 blister pack 2018-08-06 0000-00-00 No No Current