Sdamlo Solution
NDC Package 81279-133-10

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Sdamlo (amlodipine) solution is amlodipine is used with or without other medications to treat high blood pressure. This formulation utilizes a solution delivery system. Marketed by Pangea Pharmaceuticals, Llc, this product is identified by NDC 81279-133 and is authorized under FDA application NDA219531.

Identification & Billing

NDC Package Code
81279-133-10
Package Description
10 BOTTLE in 1 CARTON / 2.5 mg in 1 BOTTLE
Product Code
81279-133
11-Digit Billing Format
81279013310
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sdamlo
Non-Proprietary Name
Amlodipine
Substance Name
Amlodipine Besylate
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
AMLODIPINE BESYLATE 2.5 mg/2.5mg
Pharmacologic Class
Usage Information
Amlodipine is used with or without other medications to treat high blood pressure. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Amlodipine belongs to a class of drugs known as calcium channel blockers. It works by relaxing blood vessels so blood can flow more easily. Amlodipine is also used to prevent certain types of chest pain (angina). It may help to increase your ability to exercise and decrease the frequency of angina attacks. It should not be used to treat attacks of chest pain when they occur. Use other medications (such as sublingual nitroglycerin) to relieve attacks of chest pain as directed by your doctor.

Regulatory & Marketing

Labeler Name
Pangea Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA219531
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-05-2026
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 81279-133-10 identifies a specific commercial package of 10 bottle in 1 carton / 2.5 mg in 1 bottle of Sdamlo, a human prescription drug labeled by Pangea Pharmaceuticals, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This solution is formulated for oral use and contains amlodipine besylate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Pangea Pharmaceuticals, Llc on February 05, 2026. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Amlodipine is used with or without other medications to treat high blood pressure. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Amlodipine belongs to a class of drugs known as calcium channel blockers. It works by relaxing blood vessels so blood can flow more easily. Amlodipine is also used to prevent certain types of chest pain (angina). It may help to increase your ability to exercise and decrease the frequency of angina attacks. It should not be used to treat attacks of chest pain when they occur. Use other medications (such as sublingual nitroglycerin) to relieve attacks of chest pain as directed by your doctor.

How is this Pangea Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81279013310. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
81279-133-10
11-Digit CMS (5-4-2)
81279-0133-10

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.