NDC codes

FDA NDC Directory
Product NDC (as listed)31722-545Labeler and product segments. Claims need a package NDC.
Product NDC at billing width31722-0545Add 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
31722-545-013172205450131722054501100 CAPSULE in 1 BOTTLE (31722-545-01)Marketed from Dec 15, 2009
31722-545-03317220545033172205450330 CAPSULE in 1 BLISTER PACK (31722-545-03)Marketed from Dec 15, 2009
31722-545-053172205450531722054505500 CAPSULE in 1 BOTTLE (31722-545-05)Marketed from Dec 15, 2009
31722-545-1031722054510317220545101000 CAPSULE in 1 BOTTLE (31722-545-10)Marketed from Dec 15, 2009
31722-545-30317220545303172205453030 CAPSULE in 1 BOTTLE (31722-545-30)Marketed from Dec 15, 2009
31722-545-5031722054550317220545505000 CAPSULE in 1 BOTTLE (31722-545-50)Marketed from Dec 15, 2009

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 carbonate
Generic name (nonproprietary)
lithium carbonate
Active ingredients
Lithium carbonate — 300 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Camber Pharmaceuticals, Inc.NDC labeler code 31722
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090702
Marketing start
Listing expires
Identifiers
Product ID 31722-545_f0c7a72e-0f38-6613-e053-2a95a90a612cSPL ID f0c7a72e-0f38-6613-e053-2a95a90a612cSPL set ID 04518b80-7563-4544-bf05-04f286223faaRxCUI 197889, 197893, 311355UNII 2BMD2GNA4VUPC 0331722545013, 0331722544016
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

N431722054501 followed by a unit qualifier and the quantity

Package 31722-0545-01. 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 31722-545

What is NDC 31722-545?
31722-545 is the product NDC for lithium carbonate, Lithium carbonate 300 mg/1 capsule, listed with the FDA by Camber Pharmaceuticals, Inc.. It has 6 package NDCs, 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?
Camber Pharmaceuticals, Inc., NDC labeler code 31722. 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 ANDA 090702

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

FDA NDC Directory listings under ANDA 090702
ProductStrengthForm · routeLabelerProduct NDC
lithium carbonateLithium carbonate 150 mg/1CapsuleOralCamber Pharmaceuticals, Inc.31722-544
lithium carbonateLithium carbonate 600 mg/1CapsuleOralCamber Pharmaceuticals, Inc.31722-546
Lithium CarbonateLithium carbonate 300 mg/1CapsuleOralProficient Rx LP63187-304
lithium carbonateLithium carbonate 150 mg/1CapsuleOralCoupler LLC67046-1690
lithium carbonateLithium carbonate 150 mg/1CapsuleOralREMEDYREPACK INC.70518-4627
lithium carbonateLithium carbonate 300 mg/1CapsuleOralBryant Ranch Prepack71335-0120
lithium carbonateLithium carbonate 300 mg/1CapsuleOralAphena Pharma Solutions - Tennessee, LLC71610-557

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