Home NDC 61919-276 DOXYCYCLINE
Product NDC 61919-276
11-digit product format 619190276
Labeler code 61919
Product ID 61919-276_4c4a0016-0fb6-1dc9-e063-6294a90a9541
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DOXYCYCLINE
Dosage form CAPSULE
Route ORAL
Labeler DIRECT RX
Application ANDA204446
Marketing category ANDA
Marketing start 2016-03-17
Substance DOXYCYCLINE
Active strength 100 mg/1
Pharmacologic classes Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204446-001 DOXYCYCLINE DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL 2015-05-28 A204446-002 DOXYCYCLINE DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL 2015-05-28 A204446-003 DOXYCYCLINE DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL 2015-05-28
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 A204446-001 DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL 2015-05-28 a50c72e98297…2026-08-01 22:54:32 2026-06 A204446-002 DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL 2015-05-28 a50c72e98297…2026-08-01 22:54:32 2026-06 A204446-003 DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL 2015-05-28 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 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1649990 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 61919-276-20 DOXYCYCLINE 20 in 1 BOTTLE CAPSULE 20 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61919-276 DOXYCYCLINE CAPSULE DOXYCYCLINE MONOHYDRATE CAPSULE [DIRECT RX] 4 Current NDC, Legacy NDC, 1 package rows 20230113_31512ece-cb16-2a9a-e054-00144ff88e88.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 61919-276-20 61919027620 20 CAPSULE in 1 BOTTLE (61919-276-20) 20 capsule 2016-03-17 0000-00-00 No No Current