oracea

Generic: doxycycline

Labeler: galderma laboratories, l.p.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name oracea
Generic Name doxycycline
Labeler galderma laboratories, l.p.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

doxycycline 40 mg/1

Manufacturer
Galderma Laboratories, L.P.

Identifiers & Regulatory

Product NDC 0299-3822
Product ID 0299-3822_67eef1b6-593a-4277-abd3-f3e60e7557b0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA050805
Listing Expiration 2027-12-31
Marketing Start 2010-05-14

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 02993822
Hyphenated Format 0299-3822

Supplemental Identifiers

RxCUI
901399 901401
UNII
N12000U13O
NUI
N0000175882 N0000007948

Packaging Origin

Original Packager
true

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 oracea (source: ndc)
Generic Name doxycycline (source: ndc)
Application Number NDA050805 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (0299-3822-30)
source: ndc

Packages (1)

0299-3822-30 30 CAPSULE in 1 BOTTLE (0299-3822-30)

Ingredients (1)

doxycycline (40 mg/1)

Linked Drug Pages (1)

ORACEA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "67eef1b6-593a-4277-abd3-f3e60e7557b0", "openfda": {"nui": ["N0000175882", "N0000007948"], "unii": ["N12000U13O"], "rxcui": ["901399", "901401"], "spl_set_id": ["aa15c93a-ff4c-447a-8a21-96da506d8997"], "pharm_class_cs": ["Tetracyclines [Chemical/Ingredient]"], "pharm_class_epc": ["Tetracycline-class Drug [EPC]"], "manufacturer_name": ["Galderma Laboratories, L.P."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (0299-3822-30)", "package_ndc": "0299-3822-30", "marketing_start_date": "20100514"}], "brand_name": "ORACEA", "product_id": "0299-3822_67eef1b6-593a-4277-abd3-f3e60e7557b0", "dosage_form": "CAPSULE", "pharm_class": ["Tetracycline-class Drug [EPC]", "Tetracyclines [CS]"], "product_ndc": "0299-3822", "generic_name": "DOXYCYCLINE", "labeler_name": "Galderma Laboratories, L.P.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ORACEA", "active_ingredients": [{"name": "DOXYCYCLINE", "strength": "40 mg/1"}], "application_number": "NDA050805", "marketing_category": "NDA", "marketing_start_date": "20100514", "listing_expiration_date": "20271231"}