Prescription drug · ANDA
Lithium NDC 71656-072
Lithium citrate 8 meq/5mL · Solution · Oral · Saptalis Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71656-072-16 | 71656007216 | 473 mL in 1 BOTTLE (71656-072-16)Marketed from Apr 5, 2024 | |
| 71656-072-50 | 71656007250 | 5 TRAY in 1 CASE (71656-072-50) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (71656-072-05)Marketed from Mar 28, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Lithium
- Generic name (nonproprietary)
- lithium
- Active ingredients
- Lithium citrate — 8 meq/5mL
- Dosage form
- Solution
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217183
- Marketing start
- Listing expires
- Identifiers
- Product ID 71656-072_3ccc30e9-1f5d-5715-e063-6394a90a6bc1SPL ID 3ccc30e9-1f5d-5715-e063-6394a90a6bc1SPL set ID e95036c7-542a-437a-969b-f95f6f949f84RxCUI 756059UNII 5Z6E9K79YV
- Pharmacologic class
- Mood Stabilizer
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N471656007216followed by a unit qualifier and the quantityPackage 71656-0072-16. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Lithium oral solution is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder: Treatment of acute manic and mixed episodes in patients 7 years and older [see Clinical Studies ( 14 )]. Maintenance treatment in patients 7 years and older [see Clinical Studies ( 14 )]. Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder: Treatment of acute manic and mixed episodes in patients 7 years and older ( 1 ). Maintenance treatment in patients 7 years and older ( 1 ).
Excerpt only. Read the full label for complete information.