Home NDC 46708-785 DOXYCYCLINE
Product NDC 46708-785
11-digit product format 467080785
Labeler code 46708
Product ID 46708-785_8e78dc54-8322-435d-8879-4bfe37f1b98c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DOXYCYCLINE
Dosage form CAPSULE
Route ORAL
Labeler Alembic Pharmaceuticals Limited
Application ANDA217674
Marketing category ANDA
Marketing start 2024-06-27
Substance DOXYCYCLINE
Active strength 40 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217674-001 DOXYCYCLINE DOXYCYCLINE 40MG CAPSULE / ORAL AB 2024-06-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217674-001 AB
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 2026-02-19 14:30 UTC 2026-02 A217674-001 DOXYCYCLINE 40MG CAPSULE / ORAL AB 2024-06-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217674-001 DOXYCYCLINE 40MG CAPSULE / ORAL AB 2024-06-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217674-001 DOXYCYCLINE 40MG CAPSULE / ORAL AB 2024-06-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217674-001 DOXYCYCLINE 40MG CAPSULE / ORAL AB 2024-06-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217674-001 DOXYCYCLINE 40MG CAPSULE / ORAL AB 2024-06-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217674-001 DOXYCYCLINE 40MG CAPSULE / ORAL AB 2024-06-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217674-001 DOXYCYCLINE 40MG CAPSULE / ORAL AB 2024-06-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217674-001 DOXYCYCLINE 40MG CAPSULE / ORAL AB 2024-06-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217674-001 DOXYCYCLINE 40MG CAPSULE / ORAL AB 2024-06-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217674-001 DOXYCYCLINE 40MG CAPSULE / ORAL AB 2024-06-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217674-001 DOXYCYCLINE 40MG CAPSULE / ORAL AB 2024-06-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217674-001 DOXYCYCLINE 40MG CAPSULE / ORAL AB 2024-06-27 301d65b070ca…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217674-001 DOXYCYCLINE 40MG CAPSULE / ORAL AB 2024-06-27 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 · 2 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 40 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 901399 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 46708-785-30 DOXYCYCLINE 30 in 1 BOTTLE CAPSULE 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46708-785 DOXYCYCLINE CAPSULE [ALEMBIC PHARMACEUTICALS LIMITED] 1 Current NDC, 1 package rows 20240704_8e78dc54-8322-435d-8879-4bfe37f1b98c.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 46708-785-30 46708078530 30 CAPSULE in 1 BOTTLE (46708-785-30) 30 capsule 2024-06-27 No No Current