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 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 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.
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 A065356-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL AB 2006-05-31 a50c72e98297…2026-08-01 22:54:32 2026-06 A065356-002 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL AB 2006-05-31 a50c72e98297…2026-08-01 22:54:32 2026-06 A065356-003 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL AB 2006-05-31 a50c72e98297…2026-08-01 22:54:32 2026-06 A065356-004 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL AB 2010-07-29 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 · 1 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 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
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