carglumic acid

Generic: carglumic acid

Labeler: navinta llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name carglumic acid
Generic Name carglumic acid
Labeler navinta llc
Dosage Form TABLET, FOR SUSPENSION
Routes
ORAL
Active Ingredients

carglumic acid 200 mg/1

Manufacturer
Navinta LLC

Identifiers & Regulatory

Product NDC 68475-006
Product ID 68475-006_55e79bd0-56bd-4095-aa7e-942b3e5c1b40
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213395
Listing Expiration 2026-12-31
Marketing Start 2022-08-01

Pharmacologic Class

Established (EPC)
carbamoyl phosphate synthetase 1 activator [epc]
Mechanism of Action
carbamoyl phosphate synthetase 1 activators [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68475006
Hyphenated Format 68475-006

Supplemental Identifiers

RxCUI
905390
UNII
5L0HB4V1EW
NUI
N0000184144 N0000184143

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 carglumic acid (source: ndc)
Generic Name carglumic acid (source: ndc)
Application Number ANDA213395 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 5 TABLET, FOR SUSPENSION in 1 BOTTLE (68475-006-01)
  • 60 TABLET, FOR SUSPENSION in 1 BOTTLE (68475-006-02)
source: ndc

Packages (2)

68475-006-01 5 TABLET, FOR SUSPENSION in 1 BOTTLE (68475-006-01) 68475-006-02 60 TABLET, FOR SUSPENSION in 1 BOTTLE (68475-006-02)

Ingredients (1)

carglumic acid (200 mg/1)

Linked Drug Pages (1)

Carglumic acid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "55e79bd0-56bd-4095-aa7e-942b3e5c1b40", "openfda": {"nui": ["N0000184144", "N0000184143"], "unii": ["5L0HB4V1EW"], "rxcui": ["905390"], "spl_set_id": ["59e73eb8-edf8-4fad-93c2-deb6b23497f8"], "pharm_class_epc": ["Carbamoyl Phosphate Synthetase 1 Activator [EPC]"], "pharm_class_moa": ["Carbamoyl Phosphate Synthetase 1 Activators [MoA]"], "manufacturer_name": ["Navinta LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 TABLET, FOR SUSPENSION in 1 BOTTLE (68475-006-01)", "package_ndc": "68475-006-01", "marketing_start_date": "20220801"}, {"sample": false, "description": "60 TABLET, FOR SUSPENSION in 1 BOTTLE (68475-006-02)", "package_ndc": "68475-006-02", "marketing_start_date": "20220801"}], "brand_name": "Carglumic acid", "product_id": "68475-006_55e79bd0-56bd-4095-aa7e-942b3e5c1b40", "dosage_form": "TABLET, FOR SUSPENSION", "pharm_class": ["Carbamoyl Phosphate Synthetase 1 Activator [EPC]", "Carbamoyl Phosphate Synthetase 1 Activators [MoA]"], "product_ndc": "68475-006", "generic_name": "Carglumic acid", "labeler_name": "Navinta LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Carglumic acid", "active_ingredients": [{"name": "CARGLUMIC ACID", "strength": "200 mg/1"}], "application_number": "ANDA213395", "marketing_category": "ANDA", "marketing_start_date": "20220801", "listing_expiration_date": "20261231"}