Prescription drug · ANDA
Benzonatate NDC 65841-843
Benzonatate 200 mg/1 · Capsule · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65841-843-01 | 6584108430165841084301 | 100 CAPSULE in 1 BOTTLE (65841-843-01)Marketed from Sep 4, 2007 |
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
- Generic name (nonproprietary)
- benzonatate
- Active ingredients
- Benzonatate — 200 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Zydus Lifesciences LimitedNDC labeler code 65841
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040597
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Tracheobronchial Stretch Receptor Activity (Physiologic effect)
- Identifiers
- Product ID 65841-843_fb123061-e971-4394-aa10-ae733de31be1SPL ID fb123061-e971-4394-aa10-ae733de31be1SPL set ID abb4360a-4c52-45b6-9b80-df3c1bfc4c59RxCUI 197397, 283417UNII 5P4DHS6ENR
- 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
N465841084301followed by a unit qualifier and the quantityPackage 65841-0843-01. 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
Current FDA label (SPL), effective .
About NDC 65841-843
- What is NDC 65841-843?
- 65841-843 is the product NDC for Benzonatate, Benzonatate 200 mg/1 capsule, listed with the FDA by Zydus Lifesciences Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Benzonatate.
- What is the active ingredient?
- Benzonatate.
- Who is the labeler?
- Zydus Lifesciences Limited, NDC labeler code 65841. 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?
- 134 other product NDCs are listed under this name. See all Benzonatate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Benzonatate 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 | Benzonatate 100 mg/1 | CapsuleOral | Strides Pharma Science Limited | 64380-712 | 64380-0712-0664380-0712-07 |
| Benzonatate | Benzonatate 200 mg/1 | CapsuleOral | Strides Pharma Science Limited | 64380-713 | 64380-0713-0664380-0713-07 |
| Benzonatate | Benzonatate 150 mg/1 | CapsuleOral | Anvi Pharmaceuticals Inc | 87519-111 | 87519-0111-90 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4558 | 70518-4558-0070518-4558-0170518-4558-02+1 more |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | Coupler LLC | 67046-1629 | 67046-1629-03 |
| Benzonatate | Benzonatate 200 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4497 | 70518-4497-0070518-4497-01 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | St. Mary's Medical Park Pharmacy | 60760-869 | 60760-0869-1560760-0869-30 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | Coupler LLC | 67046-1484 | 67046-1484-03 |
| Benzonatate | Benzonatate 200 mg/1 | CapsuleOral | Direct_rx | 72189-606 | 72189-0606-2072189-0606-30 |
| Benzonatate | Benzonatate 100 mg/1 | Capsule, Liquid filledOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-898 | 23155-0898-0123155-0898-05 |
Other NDCs under ANDA 040597
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 | Benzonatate 200 mg/1 | Capsule, Liquid filledOral | Zydus Pharmaceuticals USA Inc. | 68382-091 |
| Benzonatate | Benzonatate 200 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8405 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | Zydus Lifesciences Limited | 65841-614 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-6387 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0091 |
| Benzonatate | Benzonatate 100 mg/1 | Capsule, Liquid filledOral | Zydus Pharmaceuticals USA Inc. | 68382-247 |
| Benzonatate | Benzonatate 200 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2790 |
| Benzonatate | Benzonatate 200 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2590 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | American Health Packaging | 68084-214 |
| Benzonatate | Benzonatate 200 mg/1 | CapsuleOral | Redpharm Drug | 67296-2153 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-6850 |
| Benzonatate | Benzonatate 100 mg/1 | Capsule, Liquid filledOral | Major Pharmaceuticals | 0904-6564 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | DIRECT RX | 61919-400 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | Proficient Rx LP | 63187-799 |