Home NDC 62135-263 Doxycycline Monohydrate
Product NDC 62135-263
11-digit product format 621350263
Labeler code 62135
Product ID 62135-263_3ac1aaae-d186-cf72-e063-6394a90a1dbe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxycycline Monohydrate
Dosage form CAPSULE
Route ORAL
Labeler Chartwell RX, LLC.
Application NDA050641
Marketing category NDA AUTHORIZED GENERIC
Marketing start 1989-12-29
Substance DOXYCYCLINE
Active strength 150 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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N050641-001 MONODOX DOXYCYCLINE EQ 100MG BASE CAPSULE / ORAL AB RLD 1989-12-29 N050641-002 MONODOX DOXYCYCLINE EQ 50MG BASE CAPSULE / ORAL AB RLD 1992-02-10 N050641-003 MONODOX DOXYCYCLINE EQ 75MG BASE CAPSULE / ORAL AB RLD 2006-10-18 N050641-004 MONODOX DOXYCYCLINE EQ 150MG BASE CAPSULE / ORAL AB RLD 2022-02-17
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.
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 N050641-001 MONODOX EQ 100MG BASE CAPSULE / ORAL AB RLD 1989-12-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N050641-002 MONODOX EQ 50MG BASE CAPSULE / ORAL AB RLD 1992-02-10 a50c72e98297…2026-08-01 22:54:32 2026-06 N050641-003 MONODOX EQ 75MG BASE CAPSULE / ORAL AB RLD 2006-10-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N050641-004 MONODOX EQ 150MG BASE CAPSULE / ORAL AB RLD 2022-02-17 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 Monohydrate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOXYCYCLINE 150 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 700408 Internal RxNorm lookup 728207 Internal RxNorm lookup 1649401 Internal RxNorm lookup 1649990 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 62135-263-60 Doxycycline Monohydrate 60 in 1 BOTTLE CAPSULE 60 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-263 DOXYCYCLINE MONOHYDRATE CAPSULE [CHARTWELL RX, LLC.] 9 Current NDC, Legacy NDC, 1 package rows 20250429_02aa8731-d40f-43d8-8b63-a79a0503f8db.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 62135-263-60 62135026360 60 CAPSULE in 1 BOTTLE (62135-263-60) 60 capsule 2022-02-17 0000-00-00 No No Current