Prescription drug · ANDA
lithium carbonate NDC 71335-0120
Lithium carbonate 300 mg/1 · Capsule · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-0120-1 | 71335012001 | 60 CAPSULE in 1 BOTTLE (71335-0120-1)Marketed from Dec 16, 2021 | |
| 71335-0120-2 | 71335012002 | 100 CAPSULE in 1 BOTTLE (71335-0120-2)Marketed from Dec 16, 2021 | |
| 71335-0120-3 | 71335012003 | 30 CAPSULE in 1 BOTTLE (71335-0120-3)Marketed from Dec 16, 2021 | |
| 71335-0120-4 | 71335012004 | 90 CAPSULE in 1 BOTTLE (71335-0120-4)Marketed from Dec 16, 2021 | |
| 71335-0120-5 | 71335012005 | 120 CAPSULE in 1 BOTTLE (71335-0120-5)Marketed from Dec 16, 2021 |
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
- Capsule
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 71335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090702
- Marketing start
- Listing expires
- Identifiers
- Product ID 71335-0120_8dcb81bf-5383-4227-8315-13469ad46a49SPL ID 8dcb81bf-5383-4227-8315-13469ad46a49SPL set ID bfececc8-b2ab-47d1-b126-1c6592bc9c26RxCUI 197889UNII 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
N471335012001followed by a unit qualifier and the quantityPackage 71335-0120-01. 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 for the treatment of manic episodes and as maintenance treatment for Bipolar I Disorder. Lithium is a mood stabilizing agent indicated for the treatment of manic episodes and as maintenance treatment for Bipolar I Disorder ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 71335-0120
- What is NDC 71335-0120?
- 71335-0120 is the product NDC for lithium carbonate, Lithium carbonate 300 mg/1 capsule, listed with the FDA by Bryant Ranch Prepack. It has 5 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?
- Bryant Ranch Prepack, NDC labeler code 71335. 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.
Related NDCs: other lithium carbonate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lithium Carbonate | Lithium carbonate 300 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-0886 | 00054-0886-2500054-0886-31 |
| Lithium Carbonate | Lithium carbonate 150 mg/1 | Capsule, Gelatin coatedOral | Hikma Pharmaceuticals USA Inc. | 0054-0887 | 00054-0887-25 |
| Lithium Carbonate | Lithium carbonate 300 mg/1 | Capsule, Gelatin coatedOral | Hikma Pharmaceuticals USA Inc. | 0054-0890 | 00054-0890-2500054-0890-31 |
| Lithium Carbonate | Lithium carbonate 600 mg/1 | Capsule, Gelatin coatedOral | Hikma Pharmaceuticals USA Inc. | 0054-0891 | 00054-0891-25 |
| lithium carbonate | Lithium carbonate 150 mg/1 | CapsuleOral | Coupler LLC | 67046-1690 | 67046-1690-03 |
| Lithium Carbonate | Lithium carbonate 450 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4678 | 70518-4678-00 |
| Lithium Carbonate | Lithium carbonate 600 mg/1 | CapsuleOral | American Health Packaging | 60687-964 | 60687-0964-21 |
| Lithium Carbonate | Lithium carbonate 150 mg/1 | CapsuleOral | Coupler LLC | 67046-0547 | 67046-0547-03 |
| lithium carbonate | Lithium carbonate 150 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4627 | 70518-4627-00 |
| Lithium Carbonate | Lithium carbonate 300 mg/1 | Tablet, Film coated, Extended releaseOral | Coupler LLC | 67046-1575 | 67046-1575-03 |
Other NDCs under ANDA 090702
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| lithium carbonate | Lithium carbonate 150 mg/1 | CapsuleOral | Camber Pharmaceuticals, Inc. | 31722-544 |
| lithium carbonate | Lithium carbonate 300 mg/1 | CapsuleOral | Camber Pharmaceuticals, Inc. | 31722-545 |
| lithium carbonate | Lithium carbonate 600 mg/1 | CapsuleOral | Camber Pharmaceuticals, Inc. | 31722-546 |
| Lithium Carbonate | Lithium carbonate 300 mg/1 | CapsuleOral | Proficient Rx LP | 63187-304 |
| lithium carbonate | Lithium carbonate 150 mg/1 | CapsuleOral | Coupler LLC | 67046-1690 |
| lithium carbonate | Lithium carbonate 150 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4627 |
| lithium carbonate | Lithium carbonate 300 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-557 |