Prescription drug · ANDA
Benzonatate 100 mg (Benzonatate) NDC 49483-946
Benzonatate 100 mg/1 · Capsule, Liquid filled · Oral · TIME CAP LABORATORIES, INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49483-946-01 | 4948309460149483094601 | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (49483-946-01)Marketed from Sep 14, 2026 | |
| 49483-946-50 | 4948309465049483094650 | 500 CAPSULE, LIQUID FILLED in 1 BOTTLE (49483-946-50)Marketed from Sep 14, 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
- Active ingredients
- Benzonatate — 100 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- TIME CAP LABORATORIES, INCNDC labeler code 49483
- 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 49483-946_5adfd35d-e709-e09a-e063-6394a90af04eSPL ID 5adfd35d-e709-e09a-e063-6394a90af04e
- 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
N449483094601followed by a unit qualifier and the quantityPackage 49483-0946-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 49483-946
- What is NDC 49483-946?
- 49483-946 is the product NDC for Benzonatate 100 mg (benzonatate), Benzonatate 100 mg/1 capsule, liquid filled, listed with the FDA by TIME CAP LABORATORIES, INC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Benzonatate 100 mg (Benzonatate).
- What is the active ingredient?
- Benzonatate.
- Who is the labeler?
- TIME CAP LABORATORIES, INC, NDC labeler code 49483. 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 mg | Benzonatate 100 mg/1 | Capsule, Liquid filledOral | MARKSANS PHARMA LIMITED | 25000-002 | 25000-0002-0325000-0002-0825000-0002-12 |
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 mg | Benzonatate 100 mg/1 | Capsule, Liquid filledOral | MARKSANS PHARMA LIMITED | 25000-002 |
| 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 |