Prescription drug · NDA
Sdamlo (Amlodipine) NDC 81279-135
Amlodipine besylate 10 mg/10mg · Solution · Oral · Pangea Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81279-135-10 | 8127901351081279013510 | 10 BOTTLE in 1 CARTON (81279-135-10) / 10 mg in 1 BOTTLEMarketed from Oct 2, 2026 |
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)
- Sdamlo
- Generic name (nonproprietary)
- amlodipine
- Active ingredients
- Amlodipine besylate — 10 mg/10mg
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Pangea Pharmaceuticals, LLCNDC labeler code 81279
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 219531
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 81279-135_5c8734fd-776b-0dd0-e063-6394a90a97baSPL ID 5c8734fd-776b-0dd0-e063-6394a90a97ba
- Pharmacologic class
- Calcium Channel Blocker; Dihydropyridine Calcium Channel Blocker
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
N481279013510followed by a unit qualifier and the quantityPackage 81279-0135-10. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 81279-135
- What is NDC 81279-135?
- 81279-135 is the product NDC for Sdamlo (amlodipine), Amlodipine besylate 10 mg/10mg solution, listed with the FDA by Pangea Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sdamlo (Amlodipine).
- What is the active ingredient?
- Amlodipine besylate.
- Who is the labeler?
- Pangea Pharmaceuticals, LLC, NDC labeler code 81279. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sdamlo?
- 2 other product NDCs are listed under this name. See all Sdamlo NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sdamlo products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sdamloamlodipine | Amlodipine besylate 2.5 mg/2.5mg | SolutionOral | Pangea Pharmaceuticals, LLC | 81279-133 | 81279-0133-10 |
| Sdamloamlodipine | Amlodipine besylate 5 mg/5mg | SolutionOral | Pangea Pharmaceuticals, LLC | 81279-134 | 81279-0134-10 |
Other NDCs under NDA 219531
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 |
|---|---|---|---|---|
| Sdamloamlodipine | Amlodipine besylate 2.5 mg/2.5mg | SolutionOral | Pangea Pharmaceuticals, LLC | 81279-133 |
| Sdamloamlodipine | Amlodipine besylate 5 mg/5mg | SolutionOral | Pangea Pharmaceuticals, LLC | 81279-134 |