Prescription drug · ANDA
lithium carbonate NDC 71610-557
Lithium carbonate 300 mg/1 · Capsule · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-557-70 | 71610055770 | 120 CAPSULE in 1 BOTTLE (71610-557-70)Marketed from May 20, 2021 |
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
- Capsule
- Route
- Oral
- Labeler
- Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090702
- Marketing start
- Listing expires
- Identifiers
- Product ID 71610-557_b418ff9e-6e72-4171-915b-4c1ec67c13c3SPL ID b418ff9e-6e72-4171-915b-4c1ec67c13c3SPL set ID 2b81eabc-5c5a-4b63-88d4-3f13b45a683eRxCUI 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
N471610055770followed by a unit qualifier and the quantityPackage 71610-0557-70. 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 71610-557
- What is NDC 71610-557?
- 71610-557 is the product NDC for lithium carbonate, Lithium carbonate 300 mg/1 capsule, listed with the FDA by Aphena Pharma Solutions - Tennessee, 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?
- Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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.
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 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 300 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-0886 | 00054-0886-2500054-0886-31 |
| 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 300 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0120 |
| lithium carbonate | Lithium carbonate 150 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4627 |
| lithium carbonate | Lithium carbonate 150 mg/1 | CapsuleOral | Coupler LLC | 67046-1690 |
| Lithium Carbonate | Lithium carbonate 300 mg/1 | CapsuleOral | Proficient Rx LP | 63187-304 |
| 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 |