NDC codes

FDA NDC Directory
Product NDC (as listed)0054-2526Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00054-2526Add 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
0054-2526-250005425262500054252625100 CAPSULE, GELATIN COATED in 1 BOTTLE (0054-2526-25)Marketed from Jan 28, 1987

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 Carbonate
Generic name (nonproprietary)
lithium carbonate
Active ingredients
Lithium carbonate — 150 mg/1
Dosage form
Capsule, Gelatin coated
Route
Oral
Labeler
Hikma Pharmaceuticals USA Inc.NDC labeler code 0054
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 017812
Marketing start
Listing expires
Identifiers
Product ID 0054-2526_a9e58e66-6569-4c3b-993f-b4236904296eSPL ID a9e58e66-6569-4c3b-993f-b4236904296eSPL set ID 7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84eRxCUI 197889, 197890, 197893, 311355, 756059UNII 2BMD2GNA4VUPC 0300543527638
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

N400054252625 followed by a unit qualifier and the quantity

Package 00054-2526-25. 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 0054-2526

What is NDC 0054-2526?
0054-2526 is the product NDC for Lithium Carbonate, Lithium carbonate 150 mg/1 capsule, gelatin coated, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Lithium Carbonate.
What is the active ingredient?
Lithium carbonate.
Who is the labeler?
Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. 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 Carbonate?
61 other product NDCs are listed under this name. See all Lithium Carbonate 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 Carbonate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Lithium CarbonateLithium carbonate 300 mg/1TabletOralHikma Pharmaceuticals USA Inc.0054-088600054-0886-2500054-0886-31
Lithium CarbonateLithium carbonate 150 mg/1Capsule, Gelatin coatedOralHikma Pharmaceuticals USA Inc.0054-088700054-0887-25
Lithium CarbonateLithium carbonate 300 mg/1Capsule, Gelatin coatedOralHikma Pharmaceuticals USA Inc.0054-089000054-0890-2500054-0890-31
Lithium CarbonateLithium carbonate 600 mg/1Capsule, Gelatin coatedOralHikma Pharmaceuticals USA Inc.0054-089100054-0891-25
lithium carbonateLithium carbonate 150 mg/1CapsuleOralCoupler LLC67046-169067046-1690-03
Lithium CarbonateLithium carbonate 450 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-467870518-4678-00
Lithium CarbonateLithium carbonate 600 mg/1CapsuleOralAmerican Health Packaging60687-96460687-0964-21
Lithium CarbonateLithium carbonate 150 mg/1CapsuleOralCoupler LLC67046-054767046-0547-03
lithium carbonateLithium carbonate 150 mg/1CapsuleOralREMEDYREPACK INC.70518-462770518-4627-00
Lithium CarbonateLithium carbonate 300 mg/1Tablet, Film coated, Extended releaseOralCoupler LLC67046-157567046-1575-03

All 62 Lithium Carbonate NDCs

Other NDCs under NDA 017812

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

FDA NDC Directory listings under NDA 017812
ProductStrengthForm · routeLabelerProduct NDC
Lithium CarbonateLithium carbonate 600 mg/1Capsule, Gelatin coatedOralHikma Pharmaceuticals USA Inc.0054-0891
Lithium CarbonateLithium carbonate 600 mg/1Capsule, Gelatin coatedOralPD-Rx Pharmaceuticals, Inc.72789-172
Lithium CarbonateLithium carbonate 300 mg/1Capsule, Gelatin coatedOralPD-Rx Pharmaceuticals, Inc.72789-173
Lithium CarbonateLithium carbonate 600 mg/1Capsule, Gelatin coatedOralHikma Pharmaceuticals USA Inc.0054-2531
Lithium CarbonateLithium carbonate 150 mg/1Capsule, Gelatin coatedOralHikma Pharmaceuticals USA Inc.0054-0887
Lithium CarbonateLithium carbonate 150 mg/1Capsule, Gelatin coatedOralHikma Pharmaceuticals USA Inc.0054-8526
Lithium CarbonateLithium carbonate 600 mg/1Capsule, Gelatin coatedOralREMEDYREPACK INC.70518-2345
Lithium CarbonateLithium carbonate 150 mg/1Capsule, Gelatin coatedOralREMEDYREPACK INC.70518-1434
Lithium CarbonateLithium carbonate 300 mg/1Capsule, Gelatin coatedOralHikma Pharmaceuticals USA Inc.0054-0890
Lithium CarbonateLithium carbonate 300 mg/1Capsule, Gelatin coatedOralHikma Pharmaceuticals USA Inc.0054-8527
Lithium CarbonateLithium carbonate 300 mg/1Capsule, Gelatin coatedOralCardinal Health 107, LLC55154-4920
Lithium CarbonateLithium carbonate 300 mg/1Capsule, Gelatin coatedOralHikma Pharmaceuticals USA Inc.0054-2527

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