Prescription drug · ANDA
Lithium NDC 70518-4227
Lithium citrate 8 meq/5mL · Solution · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4227-0 | 7051842270070518422700 | 10 CUP in 1 BOX (70518-4227-0) / 5 mL in 1 CUP (70518-4227-1)Marketed from Nov 4, 2024 | |
| 70518-4227-2 | 7051842270270518422702 | 10 CUP, UNIT-DOSE in 1 BOX (70518-4227-2) / 10 mL in 1 CUP, UNIT-DOSE (70518-4227-3)Marketed from Nov 5, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Labeler
- REMEDYREPACK INC.NDC labeler code 70518
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218036
- Marketing start
- Listing expires
- Identifiers
- Product ID 70518-4227_5a5d5889-cbba-dc8e-e063-6294a90a623bSPL ID 5a5d5889-cbba-dc8e-e063-6294a90a623bSPL set ID be1346df-4a39-45e8-874b-e2a496847fd5RxCUI 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
N470518422700followed by a unit qualifier and the quantityPackage 70518-4227-00. 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 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.
About NDC 70518-4227
- What is NDC 70518-4227?
- 70518-4227 is the product NDC for Lithium, Lithium citrate 8 meq/5mL solution, listed with the FDA by REMEDYREPACK INC.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lithium.
- What is the active ingredient?
- Lithium citrate.
- Who is the labeler?
- REMEDYREPACK INC., NDC labeler code 70518. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lithium?
- 7 other product NDCs are listed under this name. See all Lithium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lithium products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lithium | Lithium citrate 8 meq/5mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-1027 | 00121-1027-16 |
| Lithium | Lithium citrate 8 meq/5mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-4027 | 00121-4027-94 |
| Lithiumlithium citrate | Lithium citrate 8 meq/5mL | SolutionOral | Precision Dose, Inc. | 68094-077 | 68094-0077-62 |
| Lithium | Lithium citrate 8 meq/5mL | SolutionOral | Saptalis Pharmaceuticals, LLC | 71656-072 | 71656-0072-1671656-0072-50 |
| Lithium | Lithium citrate 8 meq/5mL | SolutionOral | Advagen Pharma Ltd | 72888-172 | 72888-0172-46 |
| Lithium | Lithium citrate 8 meq/5mL | SolutionOral | Atlantic Biologicals Corp. | 17856-1172 | 17856-1172-01 |
| Lithiumlithium bromatum | Lithium bromide 3 [hp_X]/mL | LiquidOral | Marco Pharma International LLC. | 60986-1019 | 60986-1019-0360986-1019-04 |
Other NDCs under ANDA 218036
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Lithium | Lithium citrate 8 meq/5mL | SolutionOral | Atlantic Biologicals Corp. | 17856-1172 |
| Lithiumlithium citrate | Lithium citrate 8 meq/5mL | SolutionOral | Precision Dose, Inc. | 68094-077 |
| Lithium | Lithium citrate 8 meq/5mL | SolutionOral | Advagen Pharma Ltd | 72888-172 |