lithium

Generic: lithium

Labeler: saptalis pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lithium
Generic Name lithium
Labeler saptalis pharmaceuticals, llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

lithium citrate 8 meq/5mL

Manufacturer
Saptalis Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 71656-072
Product ID 71656-072_3ccc30e9-1f5d-5715-e063-6394a90a6bc1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217183
Listing Expiration 2026-12-31
Marketing Start 2024-03-28

Pharmacologic Class

Classes
mood stabilizer [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71656072
Hyphenated Format 71656-072

Supplemental Identifiers

RxCUI
756059
UNII
5Z6E9K79YV

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 lithium (source: ndc)
Generic Name lithium (source: ndc)
Application Number ANDA217183 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 meq/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (71656-072-16)
  • 5 TRAY in 1 CASE (71656-072-50) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (71656-072-05)
source: ndc

Packages (2)

71656-072-16 473 mL in 1 BOTTLE (71656-072-16) 71656-072-50 5 TRAY in 1 CASE (71656-072-50) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (71656-072-05)

Ingredients (1)

lithium citrate (8 meq/5mL)

Linked Drug Pages (1)

Lithium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3ccc30e9-1f5d-5715-e063-6394a90a6bc1", "openfda": {"unii": ["5Z6E9K79YV"], "rxcui": ["756059"], "spl_set_id": ["e95036c7-542a-437a-969b-f95f6f949f84"], "manufacturer_name": ["Saptalis Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (71656-072-16)", "package_ndc": "71656-072-16", "marketing_start_date": "20240405"}, {"sample": false, "description": "5 TRAY in 1 CASE (71656-072-50)  / 10 CUP in 1 TRAY / 5 mL in 1 CUP (71656-072-05)", "package_ndc": "71656-072-50", "marketing_start_date": "20240328"}], "brand_name": "Lithium", "product_id": "71656-072_3ccc30e9-1f5d-5715-e063-6394a90a6bc1", "dosage_form": "SOLUTION", "pharm_class": ["Mood Stabilizer [EPC]"], "product_ndc": "71656-072", "generic_name": "Lithium", "labeler_name": "Saptalis Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lithium", "active_ingredients": [{"name": "LITHIUM CITRATE", "strength": "8 meq/5mL"}], "application_number": "ANDA217183", "marketing_category": "ANDA", "marketing_start_date": "20240328", "listing_expiration_date": "20261231"}