Home NDC 64380-207 Doxycycline
Product NDC 64380-207
11-digit product format 643800207
Labeler code 64380
Product ID 64380-207_38deaa0a-0200-49e4-9251-a86dbe2119d1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name doxycycline
Dosage form TABLET
Route ORAL
Labeler Strides Pharma Science Limited
Application ANDA065070
Marketing category ANDA
Marketing start 2022-09-19
Substance DOXYCYCLINE
Active strength 100 mg/1
Pharmacologic classes Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.
Historic NDC status page 1 of 1 · 3 matching rows.
Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 64380-207 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 64380-207 64380-207-01 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 64380-207 64380-207-02 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…
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 A065070-001 DOXYCYCLINE DOXYCYCLINE EQ 50MG BASE TABLET / ORAL AB 2000-12-15 A065070-002 DOXYCYCLINE DOXYCYCLINE EQ 100MG BASE TABLET / ORAL AB 2000-12-15 A065070-003 DOXYCYCLINE DOXYCYCLINE EQ 75MG BASE TABLET / ORAL AB 2002-12-30 A065070-004 DOXYCYCLINE DOXYCYCLINE EQ 150MG BASE TABLET / ORAL AB 2005-07-14
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 · 164 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 A065070-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL AB 2000-12-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065070-002 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL AB 2000-12-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065070-003 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL AB 2002-12-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065070-004 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL AB 2005-07-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065070-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL AB 2000-12-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065070-002 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL AB 2000-12-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065070-003 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL AB 2002-12-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065070-004 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL AB 2005-07-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065070-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL AB 2000-12-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065070-002 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL AB 2000-12-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065070-003 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL AB 2002-12-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065070-004 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL AB 2005-07-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065070-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL AB 2000-12-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065070-002 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL AB 2000-12-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065070-003 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL AB 2002-12-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065070-004 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL AB 2005-07-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065070-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL AB 2000-12-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065070-002 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL AB 2000-12-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065070-003 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL AB 2002-12-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065070-004 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL AB 2005-07-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065070-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL AB 2000-12-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065070-002 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL AB 2000-12-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065070-003 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL AB 2002-12-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065070-004 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL AB 2005-07-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065070-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL AB 2000-12-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065070-002 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL AB 2000-12-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065070-003 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL AB 2002-12-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065070-004 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL AB 2005-07-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065070-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL AB 2000-12-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065070-002 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL AB 2000-12-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065070-003 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL AB 2002-12-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065070-004 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL AB 2005-07-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065070-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL AB 2000-12-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065070-002 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL AB 2000-12-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065070-003 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL AB 2002-12-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065070-004 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL AB 2005-07-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065070-001 DOXYCYCLINE EQ 50MG BASE TABLET / ORAL AB 2000-12-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065070-002 DOXYCYCLINE EQ 100MG BASE TABLET / ORAL AB 2000-12-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065070-003 DOXYCYCLINE EQ 75MG BASE TABLET / ORAL AB 2002-12-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065070-004 DOXYCYCLINE EQ 150MG BASE TABLET / ORAL AB 2005-07-14 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 124 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 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Doxycycline
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOXYCYCLINE 100 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# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 64380-207-01 2024-04-24 C162847 48780-1 1030e365-2864-111a-e063-dadaa90a10e2 Doxycycline Tablets, USP Rx only 64380-207-01 2024-04-24 C162847 48780-1 1030e365-2864-111a-e063-dadaa90a10e2 Doxycycline Tablets, USP Rx only 64380-207-02 2024-04-24 C162847 48780-1 1030e365-2864-111a-e063-dadaa90a10e2 Doxycycline Tablets, USP Rx only 64380-207-02 2024-04-24 C162847 48780-1 1030e365-2864-111a-e063-dadaa90a10e2 Doxycycline Tablets, USP Rx only 64380-207-01 2024-01-30 C162847 48780-1 1030e365-2864-111a-e063-dadaa90a10e2 Doxycycline Tablets, USP Rx only 64380-207-01 2024-01-30 C162847 48780-1 1030e365-2864-111a-e063-dadaa90a10e2 Doxycycline Tablets, USP Rx only 64380-207-02 2024-01-30 C162847 48780-1 1030e365-2864-111a-e063-dadaa90a10e2 Doxycycline Tablets, USP Rx only 64380-207-02 2024-01-30 C162847 48780-1 1030e365-2864-111a-e063-dadaa90a10e2 Doxycycline Tablets, USP Rx only
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64380-207-01 Doxycycline 50 in 1 BOTTLE TABLET 50 6 64380-207-02 Doxycycline 250 in 1 BOTTLE TABLET 250 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64380-207 DOXYCYCLINE TABLET [STRIDES PHARMA SCIENCE LIMITED] 6 Current NDC, Legacy NDC, 2 package rows 20250323_3b9888a2-ca16-43f7-ab6d-f03188ec2c0d.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 64380-207-01 64380020701 50 TABLET in 1 BOTTLE (64380-207-01) 50 tablet 2022-09-19 0000-00-00 No No Current 64380-207-02 64380020702 250 TABLET in 1 BOTTLE (64380-207-02) 250 tablet 2022-09-19 0000-00-00 No No Current