Home NDC 53002-0673-3 Doxycycline
Product NDC 53002-0673
Requested package NDC 53002-0673-3
11-digit product format 530020673
Labeler code 53002
Product ID 53002-0673_d937921d-11a0-4ba2-aa44-aef5dd995401
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxycycline
Dosage form CAPSULE
Route ORAL
Labeler RPK Pharmaceuticals, Inc.
Application ANDA065053
Marketing category ANDA
Marketing start 2000-12-26
Marketing end 0000-00-00
Substance DOXYCYCLINE
Active strength 100 mg/1
Pharmacologic classes Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53002-0673 DOXYCYCLINE CAPSULE [RPK PHARMACEUTICALS, INC.] 1 Legacy NDC, 9 package rows 20220331_e7a69d4c-8a7f-4641-821d-acf5d7be3d52.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 Units Marketing start Marketing end Sample Exclude flag Status 53002-0673-3 53002067303 14 CAPSULE in 1 BOTTLE (53002-0673-3) 14 capsule 2021-01-01 0000-00-00 No No Current