NDC codes

FDA NDC Directory
Product NDC (as listed)70518-4227Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-4227Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
70518-4227-0705184227007051842270010 CUP in 1 BOX (70518-4227-0) / 5 mL in 1 CUP (70518-4227-1)Marketed from Nov 4, 2024
70518-4227-2705184227027051842270210 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

N470518422700 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Lithium NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
LithiumLithium citrate 8 meq/5mLSolutionOralPAI Holdings, LLC dba PAI Pharma0121-102700121-1027-16
LithiumLithium citrate 8 meq/5mLSolutionOralPAI Holdings, LLC dba PAI Pharma0121-402700121-4027-94
Lithiumlithium citrateLithium citrate 8 meq/5mLSolutionOralPrecision Dose, Inc.68094-07768094-0077-62
LithiumLithium citrate 8 meq/5mLSolutionOralSaptalis Pharmaceuticals, LLC71656-07271656-0072-1671656-0072-50
LithiumLithium citrate 8 meq/5mLSolutionOralAdvagen Pharma Ltd72888-17272888-0172-46
LithiumLithium citrate 8 meq/5mLSolutionOralAtlantic Biologicals Corp.17856-117217856-1172-01
Lithiumlithium bromatumLithium bromide 3 [hp_X]/mLLiquidOralMarco Pharma International LLC.60986-101960986-1019-0360986-1019-04

Other NDCs under ANDA 218036

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 218036
ProductStrengthForm · routeLabelerProduct NDC
LithiumLithium citrate 8 meq/5mLSolutionOralAtlantic Biologicals Corp.17856-1172
Lithiumlithium citrateLithium citrate 8 meq/5mLSolutionOralPrecision Dose, Inc.68094-077
LithiumLithium citrate 8 meq/5mLSolutionOralAdvagen Pharma Ltd72888-172

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