NDC codes

FDA NDC Directory
Product NDC (as listed)46708-305Labeler and product segments. Claims need a package NDC.
Product NDC at billing width46708-0305Add 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
46708-305-304670803053030 CAPSULE in 1 BOTTLE (46708-305-30)Marketed from Dec 27, 2016
46708-305-3146708030531100 CAPSULE in 1 BOTTLE (46708-305-31)Marketed from Dec 27, 2016
46708-305-7146708030571500 CAPSULE in 1 BOTTLE (46708-305-71)Marketed from Dec 27, 2016

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 — 600 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Alembic Pharmaceuticals LimitedNDC labeler code 46708
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 079159
Marketing start
Listing expires
Identifiers
Product ID 46708-305_f4a09dd5-000a-48d2-9681-d5bc360164f1SPL ID f4a09dd5-000a-48d2-9681-d5bc360164f1SPL set ID d1800f34-3d67-4b2f-874e-8639b125d853RxCUI 197889, 197893, 311355UNII 2BMD2GNA4VUPC 0346708303303, 0346708304300, 0346708305307
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

N446708030530 followed by a unit qualifier and the quantity

Package 46708-0305-30. 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 is indicated in the treatment of manic episodes of Bipolar Disorder. Bipolar Disorder, Manic (DSM-III) is equivalent to Manic Depressive illness, Manic, in the older DSM-II terminology. Lithium is 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. When given to a patient experiencing a manic episode, lithiu…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 46708-305

What is NDC 46708-305?
46708-305 is the product NDC for Lithium Carbonate, Lithium carbonate 600 mg/1 capsule, listed with the FDA by Alembic Pharmaceuticals Limited. It has 3 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?
Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 079159

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

FDA NDC Directory listings under ANDA 079159
ProductStrengthForm · routeLabelerProduct NDC
Lithium CarbonateLithium carbonate 150 mg/1CapsuleOralAlembic Pharmaceuticals Limited46708-303
Lithium CarbonateLithium carbonate 300 mg/1CapsuleOralAlembic Pharmaceuticals Limited46708-304
Lithium Carbonate Lithium Carbonatelithium carbonateLithium carbonate 150 mg/1CapsuleOralAlembic Pharmaceuticals Inc.62332-013
Lithium Carbonate Lithium Carbonatelithium carbonateLithium carbonate 300 mg/1CapsuleOralAlembic Pharmaceuticals Inc.62332-014
Lithium Carbonate Lithium Carbonatelithium carbonateLithium carbonate 600 mg/1CapsuleOralAlembic Pharmaceuticals Inc.62332-015

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