Prescription drug · ANDA
Benzonatate 100 mg NDC 25000-002
Benzonatate 100 mg/1 · Capsule, Liquid filled · Oral · MARKSANS PHARMA LIMITED
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 25000-002-03 | 2500000020325000000203 | 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-002-03)Marketed from Apr 10, 2026 | |
| 25000-002-08 | 2500000020825000000208 | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-002-08)Marketed from Apr 10, 2026 | |
| 25000-002-12 | 2500000021225000000212 | 500 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-002-12)Marketed from Apr 10, 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)
- Benzonatate 100 mg
- Generic name (nonproprietary)
- benzonatate 100 mg
- Active ingredients
- Benzonatate — 100 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- MARKSANS PHARMA LIMITEDNDC labeler code 25000
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 220298
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Tracheobronchial Stretch Receptor Activity (Physiologic effect)
- Identifiers
- Product ID 25000-002_8668f10d-45dc-4248-88ac-6e8c5d576435SPL ID 8668f10d-45dc-4248-88ac-6e8c5d576435SPL set ID 44104cfc-df60-4d48-9fe1-53456a5e1974RxCUI 197397, 283417UNII 5P4DHS6ENRUPC 0325000002121, 0325000003036, 0325000002039, 0325000003128, 0325000003081, 0325000002084
- Pharmacologic class
- Non-narcotic Antitussive
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
N425000000203followed by a unit qualifier and the quantityPackage 25000-0002-03. 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 .
Indications (excerpt from the label)
INDICATIONS & USAGE Benzonatate capsules are indicated for the symptomatic relief of cough.
Excerpt only. Read the full label for complete information.
About NDC 25000-002
- What is NDC 25000-002?
- 25000-002 is the product NDC for Benzonatate 100 mg, Benzonatate 100 mg/1 capsule, liquid filled, listed with the FDA by MARKSANS PHARMA LIMITED. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Benzonatate 100 mg.
- What is the active ingredient?
- Benzonatate.
- Who is the labeler?
- MARKSANS PHARMA LIMITED, NDC labeler code 25000. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Benzonatate 100 mg?
- 1 other product NDC are listed under this name. See all Benzonatate 100 mg NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Benzonatate 100 mg products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Benzonatate 100 mgbenzonatate | Benzonatate 100 mg/1 | Capsule, Liquid filledOral | TIME CAP LABORATORIES, INC | 49483-946 | 49483-0946-0149483-0946-50 |
Other NDCs under ANDA 220298
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 |
|---|---|---|---|---|
| Benzonatate 100 mgbenzonatate | Benzonatate 100 mg/1 | Capsule, Liquid filledOral | TIME CAP LABORATORIES, INC | 49483-946 |
| Benzonatate 200 mg | Benzonatate 200 mg/1 | Capsule, Liquid filledOral | MARKSANS PHARMA LIMITED | 25000-003 |
| Benzonatate 200 mgbenzonatate | Benzonatate 200 mg/1 | Capsule, Liquid filledOral | TIME CAP LABORATORIES, INC | 49483-947 |