doxycycline monohydrate

Generic: doxycycline monohydrate

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxycycline monohydrate
Generic Name doxycycline monohydrate
Labeler direct_rx
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

doxycycline 100 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-358
Product ID 72189-358_2c4c8dd5-f079-0339-e063-6394a90afedb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065053
Listing Expiration 2026-12-31
Marketing Start 2022-05-26

Pharmacologic Class

Established (EPC)
tetracycline-class drug [epc]
Chemical Structure
tetracyclines [chemical/ingredient]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189358
Hyphenated Format 72189-358

Supplemental Identifiers

RxCUI
1649990
UNII
N12000U13O
NUI
N0000175882 N0000007948

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name doxycycline monohydrate (source: ndc)
Generic Name doxycycline monohydrate (source: ndc)
Application Number ANDA065053 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 20 CAPSULE in 1 BOTTLE (72189-358-20)
source: ndc

Packages (1)

72189-358-20 20 CAPSULE in 1 BOTTLE (72189-358-20)

Ingredients (1)

doxycycline (100 mg/1)

Linked Drug Pages (1)

Doxycycline Monohydrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2c4c8dd5-f079-0339-e063-6394a90afedb", "openfda": {"nui": ["N0000175882", "N0000007948"], "unii": ["N12000U13O"], "rxcui": ["1649990"], "spl_set_id": ["dfef600c-bceb-fbc9-e053-2a95a90ae6c0"], "pharm_class_cs": ["Tetracyclines [Chemical/Ingredient]"], "pharm_class_epc": ["Tetracycline-class Drug [EPC]"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "20 CAPSULE in 1 BOTTLE (72189-358-20)", "package_ndc": "72189-358-20", "marketing_start_date": "20220526"}], "brand_name": "Doxycycline Monohydrate", "product_id": "72189-358_2c4c8dd5-f079-0339-e063-6394a90afedb", "dosage_form": "CAPSULE", "pharm_class": ["Tetracycline-class Drug [EPC]", "Tetracyclines [CS]"], "product_ndc": "72189-358", "generic_name": "Doxycycline Monohydrate", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Doxycycline Monohydrate", "active_ingredients": [{"name": "DOXYCYCLINE", "strength": "100 mg/1"}], "application_number": "ANDA065053", "marketing_category": "ANDA", "marketing_start_date": "20220526", "listing_expiration_date": "20261231"}