Prescription drug · ANDA
Sildenafil Citrate NDC 70710-1716
Sildenafil citrate 10 mg/mL · Powder, For suspension · Oral · Zydus Pharmaceuticals (USA) Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70710-1716-4 | 7071017160470710171604 | 1 BOTTLE, GLASS in 1 CARTON (70710-1716-4) / 112 mL in 1 BOTTLE, GLASSMarketed from Oct 27, 2022 | |
| 70710-1716-5 | 7071017160570710171605 | 1 BOTTLE, PLASTIC in 1 CARTON (70710-1716-5) / 112 mL in 1 BOTTLE, PLASTICMarketed from Oct 27, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Sildenafil Citrate
- Generic name (nonproprietary)
- sildenafil citrate
- Active ingredients
- Sildenafil citrate — 10 mg/mL
- Dosage form
- Powder, For suspension
- Route
- Oral
- Labeler
- Zydus Pharmaceuticals (USA) Inc.NDC labeler code 70710
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215708
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 70710-1716_b42790ec-b9ad-4b34-b98d-dfb8d246eff2SPL ID b42790ec-b9ad-4b34-b98d-dfb8d246eff2SPL set ID b2f04ce4-f19c-403d-8a83-74f123e5d30aRxCUI 1307427UNII BW9B0ZE037
- Pharmacologic class
- Phosphodiesterase 5 Inhibitor
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
N470710171604followed by a unit qualifier and the quantityPackage 70710-1716-04. 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)
Adults Sildenafil for oral suspension is indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [see Clinical Studies (14) ] . Pediatric Patients (1 to 17 Years Old) Sildenafil for oral suspension is indicated in pediatric patients 1 to 17 years old for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability and, in pediatric patients too young to perform standardized exercise testing, pulmonary hemodynamics thought to underlie improvements in exercise [see Clinical Studies (14) ] . Adults Sildenafil for oral suspension is a phosp…
Excerpt only. Read the full label for complete information.
About NDC 70710-1716
- What is NDC 70710-1716?
- 70710-1716 is the product NDC for Sildenafil Citrate, Sildenafil citrate 10 mg/mL powder, for suspension, listed with the FDA by Zydus Pharmaceuticals (USA) Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sildenafil Citrate.
- What is the active ingredient?
- Sildenafil citrate.
- Who is the labeler?
- Zydus Pharmaceuticals (USA) Inc., NDC labeler code 70710. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sildenafil Citrate?
- 69 other product NDCs are listed under this name. See all Sildenafil Citrate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sildenafil Citrate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sildenafil Citratesildenafil | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4111 | 68788-4111-0168788-4111-0368788-4111-07 |
| Sildenafil Citrate | Sildenafil citrate 25 mg/1 | TabletOral | Northstar Rx LLC | 72603-883 | 72603-0883-01 |
| Sildenafil Citrate | Sildenafil citrate 50 mg/1 | TabletOral | Northstar Rx LLC | 72603-884 | 72603-0884-01 |
| Sildenafil Citrate | Sildenafil citrate 100 mg/1 | TabletOral | Northstar Rx LLC | 72603-885 | 72603-0885-0172603-0885-02 |
| Sildenafil Citrate | Sildenafil citrate 50 mg/1 | Tablet, Film coatedOral | Umedica Laboratories USA Inc. | 60290-002 | 60290-0002-0160290-0002-0260290-0002-03+1 more |
| Sildenafil Citrate | Sildenafil citrate 100 mg/1 | Tablet, Film coatedOral | Umedica Laboratories USA Inc. | 60290-003 | 60290-0003-0160290-0003-0260290-0003-03+2 more |
| Sildenafil Citrate | Sildenafil citrate 25 mg/1 | Tablet, Film coatedOral | Umedica Laboratories USA Inc. | 60290-079 | 60290-0079-0160290-0079-0260290-0079-03+1 more |
| Sildenafil Citratesildenafil | Sildenafil citrate 20 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 82868-094 | 82868-0094-30 |
| Sildenafil Citrate | Sildenafil citrate 100 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0503 | 80425-0503-0180425-0503-0280425-0503-03 |
| Sildenafil Citrate | Sildenafil citrate 100 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8804 | 68788-8804-0168788-8804-0368788-8804-07 |
Other NDCs under ANDA 215708
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 |
|---|---|---|---|---|
| Sildenafil Citrate | Sildenafil citrate 10 mg/mL | Powder, For suspensionOral | Zydus Lifesciences Limited | 70771-1668 |