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 2026-08-01 22:54:32 2026-06 A217674-001 DOXYCYCLINE 40MG CAPSULE / ORAL AB 2024-06-27 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A217674-001 AB 1 a50c72e98297…
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