Home NDC 63304-615 Doxycycline
Product NDC 63304-615
11-digit product format 633040615
Labeler code 63304
Product ID 63304-615_338488d1-e9d8-6b00-e063-6294a90a37c0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxycycline
Dosage form CAPSULE
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA065053
Marketing category ANDA
Marketing start 2000-12-26
Substance DOXYCYCLINE
Active strength 75 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 A065053-001 DOXYCYCLINE DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL AB 2000-11-22 A065053-002 DOXYCYCLINE DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL AB RS 2000-11-22 A065053-003 DOXYCYCLINE DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL AB 2003-09-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 123 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 2026-02-19 14:30 UTC 2026-02 A065053-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL AB 2000-11-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065053-002 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL AB RS 2000-11-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065053-003 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL AB 2003-09-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065053-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL AB 2000-11-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065053-002 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL AB RS 2000-11-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065053-003 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL AB 2003-09-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065053-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL AB 2000-11-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065053-002 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL AB RS 2000-11-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065053-003 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL AB 2003-09-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065053-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL AB 2000-11-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065053-002 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL AB RS 2000-11-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065053-003 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL AB 2003-09-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065053-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL AB 2000-11-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065053-002 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL AB RS 2000-11-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065053-003 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL AB 2003-09-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065053-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL AB 2000-11-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065053-002 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL AB RS 2000-11-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065053-003 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL AB 2003-09-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065053-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL AB 2000-11-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065053-002 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL AB RS 2000-11-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065053-003 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL AB 2003-09-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065053-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL AB 2000-11-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065053-002 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL AB RS 2000-11-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065053-003 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL AB 2003-09-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065053-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL AB 2000-11-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065053-002 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL AB RS 2000-11-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065053-003 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL AB 2003-09-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065053-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL AB 2000-11-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065053-002 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL AB RS 2000-11-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065053-003 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL AB 2003-09-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065053-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL AB 2000-11-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065053-002 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL AB RS 2000-11-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065053-003 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL AB 2003-09-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065053-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL AB 2000-11-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065053-002 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL AB RS 2000-11-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065053-003 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL AB 2003-09-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065053-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL AB 2000-11-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065053-002 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL AB RS 2000-11-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065053-003 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL AB 2003-09-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065053-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL AB 2000-11-22 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
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 75 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 63304-615-01 Doxycycline 100 in 1 BOTTLE CAPSULE 100 10 63304-615-05 Doxycycline 500 in 1 BOTTLE CAPSULE 500 10 63304-615-11 Doxycycline 1 in 1 BLISTER PACK CAPSULE 1 10 63304-615-11 Doxycycline 1 in 1 CARTON CAPSULE 1 10
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63304-615 DOXYCYCLINE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.] 10 Current NDC, Legacy NDC, 4 package rows 20250426_829dbd3d-5c2b-47b8-96a5-423af78c93b9.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 63304-615-01 63304061501 100 CAPSULE in 1 BOTTLE (63304-615-01) 100 capsule 2000-12-26 0000-00-00 No No Current 63304-615-05 63304061505 500 CAPSULE in 1 BOTTLE (63304-615-05) 500 capsule 2000-12-26 0000-00-00 No No Current 63304-615-11 63304061511 1 BLISTER PACK in 1 CARTON (63304-615-11) / 1 CAPSULE in 1 BLISTER PACK 1 blister pack 2000-12-26 0000-00-00 No No Current