NDC codes

FDA NDC Directory
Product NDC (as listed)67046-1575Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67046-1575Add 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
67046-1575-36704615750330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (67046-1575-3)Marketed from Sep 4, 2025

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 Carbonate
Generic name (nonproprietary)
lithium carbonate
Active ingredients
Lithium carbonate — 300 mg/1
Dosage form
Tablet, Film coated, Extended release
Route
Oral
Labeler
Coupler LLCNDC labeler code 67046
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091544
Marketing start
Listing expires
Identifiers
Product ID 67046-1575_3dfedfb7-e561-bc6d-e063-6294a90ac562SPL ID 3dfedfb7-e561-bc6d-e063-6294a90ac562SPL set ID 3dfeeb11-a096-ae17-e063-6294a90a9aaeRxCUI 197891UNII 2BMD2GNA4V
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

N467046157503 followed by a unit qualifier and the quantity

Package 67046-1575-03. 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)

INDICATIONS Lithium carbonate extended-release tablets are indicated in the treatment of manic episodes of Bipolar Disorder. Bipolar Disorder, Manic (DSM-IV) is equivalent to Manic Depressive illness, Manic, in the older DSM-II terminology. Lithium carbonate extended-release tablets are also indicated as a maintenance treatment for individuals with a diagnosis of Bipolar Disorder. Maintenance therapy reduces the frequency of manic episodes and diminishes the intensity of those episodes which may occur. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, elation, poor judgment, aggressiveness, and possibly hostility.…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67046-1575

What is NDC 67046-1575?
67046-1575 is the product NDC for Lithium Carbonate, Lithium carbonate 300 mg/1 tablet, film coated, extended release, listed with the FDA by Coupler LLC. 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?
Coupler LLC, NDC labeler code 67046. 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?
62 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 600 mg/1Capsule, Gelatin coatedOralHikma Pharmaceuticals USA Inc.0054-089100054-0891-25
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 300 mg/1TabletOralHikma Pharmaceuticals USA Inc.0054-088600054-0886-2500054-0886-31
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 150 mg/1CapsuleOralBoswell Pharmacy Services LLC d/b/a BPS Wholesale83209-22083209-0220-0683209-0220-1583209-0220-20+2 more

All 63 Lithium Carbonate NDCs

Other NDCs under ANDA 091544

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

FDA NDC Directory listings under ANDA 091544
ProductStrengthForm · routeLabelerProduct NDC
Lithium CarbonateLithium carbonate 300 mg/1Tablet, Film coated, Extended releaseOralGlenmark Pharmaceuticals Inc., USA68462-223
Lithium CarbonateLithium carbonate 300 mg/1Tablet, Film coated, Extended releaseOralA-S Medication Solutions50090-1470
Lithium CarbonateLithium carbonate 300 mg/1Tablet, Film coated, Extended releaseOralREMEDYREPACK INC.70518-3875

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