NDC codes

FDA NDC Directory
Product NDC (as listed)46708-148Labeler and product segments. Claims need a package NDC.
Product NDC at billing width46708-0148Add 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
46708-148-08467080148084670801480880 TABLET, EXTENDED RELEASE in 1 CARTON (46708-148-08)Marketed from Feb 21, 2017
46708-148-30467080148304670801483030 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-148-30)Marketed from Feb 21, 2017
46708-148-314670801483146708014831100 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-148-31)Marketed from Feb 21, 2017
46708-148-9146708014891467080148911000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-148-91)Marketed from Feb 21, 2017

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
Tablet, Extended release
Route
Oral
Labeler
Alembic Pharmaceuticals LimitedNDC labeler code 46708
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 204445
Marketing start
Listing expires
Identifiers
Product ID 46708-148_fa1dd72f-c205-4377-881e-836882c4de47SPL ID fa1dd72f-c205-4377-881e-836882c4de47SPL set ID 8e950a50-689d-4bf8-87ce-cffd43c6d5c2RxCUI 197891UNII 2BMD2GNA4VUPC 0346708148300
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

N446708014808 followed by a unit qualifier and the quantity

Package 46708-0148-08. 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, USP is 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, USP 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 p…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 46708-148

What is NDC 46708-148?
46708-148 is the product NDC for Lithium Carbonate, Lithium carbonate 300 mg/1 tablet, extended release, listed with the FDA by Alembic Pharmaceuticals Limited. It has 4 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 204445

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

FDA NDC Directory listings under ANDA 204445
ProductStrengthForm · routeLabelerProduct NDC
Lithium CarbonateLithium carbonate 300 mg/1Tablet, Extended releaseOralAlembic Pharmaceuticals Inc.62332-148

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