NDC codes

FDA NDC Directory
Product NDC (as listed)68084-655Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68084-0655Add 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
68084-655-0168084065501100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-655-01) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68084-655-11)Marketed from Jan 3, 2014

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 — 450 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076691
Marketing start
Listing expires
Identifiers
Product ID 68084-655_437e7c62-fa63-3ec3-e063-6394a90a044dSPL ID 437e7c62-fa63-3ec3-e063-6394a90a044dSPL set ID d276da3c-9952-4674-a54d-b1258df71b8aRxCUI 197892UNII 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

N468084065501 followed by a unit qualifier and the quantity

Package 68084-0655-01. 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)

INDICATIONS AND USAGE Lithium Carbonate Extended-Release Tablets are indicated in the treatment of manic episodes of manic-depressive illness. Maintenance therapy prevents or diminishes the intensity of subsequent episodes in those manic-depressive patients with a history of mania. 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. When given to a patient experiencing a manic episode, Lithium Carbonate Extended-Release Tablets may produce a normalization of symptomatology within 1 to 3 weeks.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 076691

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

FDA NDC Directory listings under ANDA 076691
ProductStrengthForm · routeLabelerProduct NDC
Lithium CarbonateLithium carbonate 450 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-4678
Lithium CarbonateLithium carbonate 450 mg/1Tablet, Extended releaseOralHikma Pharmaceuticals USA Inc.0054-0020
Lithium CarbonateLithium carbonate 450 mg/1Tablet, Extended releaseOralPD-Rx Pharmaceuticals, Inc.43063-901

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