Home NDC 64380-206-01 Doxycycline
Product NDC 64380-206
Requested package NDC 64380-206-01
11-digit product format 643800206
Labeler code 64380
Product ID 64380-206_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 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 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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 package package 64380-206 64380-206-01 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.
Additional Listing Data#
Finished product Yes
Brand name base Doxycycline
Listing expiration 2027-12-31 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 · 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64380-206-01 Doxycycline 100 in 1 BOTTLE TABLET 100 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64380-206 DOXYCYCLINE TABLET [STRIDES PHARMA SCIENCE LIMITED] 6 Current NDC, Legacy NDC, 1 package rows 20250323_3b9888a2-ca16-43f7-ab6d-f03188ec2c0d.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 64380-206-01 64380020601 100 TABLET in 1 BOTTLE (64380-206-01) 100 tablet 2022-09-19 0000-00-00 No No Current