Prescription drug · ANDA
escitalopram oxalate NDC 71335-0685
Escitalopram oxalate 20 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-0685-1 | 7133506850171335068501 | 60 TABLET in 1 BOTTLE (71335-0685-1)Marketed from Feb 27, 2018 | |
| 71335-0685-2 | 7133506850271335068502 | 28 TABLET in 1 BOTTLE (71335-0685-2)Marketed from Oct 30, 2024 | |
| 71335-0685-3 | 7133506850371335068503 | 30 TABLET in 1 BOTTLE (71335-0685-3)Marketed from Feb 22, 2018 | |
| 71335-0685-4 | 7133506850471335068504 | 90 TABLET in 1 BOTTLE (71335-0685-4)Marketed from Feb 12, 2018 | |
| 71335-0685-5 | 7133506850571335068505 | 120 TABLET in 1 BOTTLE (71335-0685-5)Marketed from Oct 30, 2024 | |
| 71335-0685-6 | 7133506850671335068506 | 100 TABLET in 1 BOTTLE (71335-0685-6)Marketed from Oct 30, 2024 | |
| 71335-0685-7 | 7133506850771335068507 | 45 TABLET in 1 BOTTLE (71335-0685-7)Marketed from Oct 30, 2024 | |
| 71335-0685-8 | 7133506850871335068508 | 180 TABLET in 1 BOTTLE (71335-0685-8)Marketed from Oct 30, 2024 |
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)
- escitalopram oxalate
- Generic name (nonproprietary)
- escitalopram oxalate
- Active ingredients
- Escitalopram oxalate — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 71335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090939
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 71335-0685_7cb6e260-dd56-42fd-aaca-4cc1fd460884SPL ID 7cb6e260-dd56-42fd-aaca-4cc1fd460884SPL set ID 86cfcd96-6397-42ef-8a79-f62706f0aca6RxCUI 351250UNII 5U85DBW7LO
- Pharmacologic class
- Serotonin Reuptake 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
N471335068501followed by a unit qualifier and the quantityPackage 71335-0685-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Escitalopram is a selective serotonin reuptake inhibitor (SSRI) indicated for the: • treatment of major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older ( 1 ) • treatment of generalized anxiety disorder (GAD) in adults ( 1 ) Escitalopram tablets are indicated for the treatment of: • major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older. • generalized anxiety disorder (GAD) in adults. Additional pediatric use information is approved for AbbVie Inc.’s LEXAPRO ® (escitalopram) tablets. However, due to AbbVie Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.
Excerpt only. Read the full label for complete information.
About NDC 71335-0685
- What is NDC 71335-0685?
- 71335-0685 is the product NDC for escitalopram oxalate, Escitalopram oxalate 20 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 8 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- escitalopram oxalate.
- What is the active ingredient?
- Escitalopram oxalate.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 71335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for escitalopram oxalate?
- 40 other product NDCs are listed under this name. See all escitalopram oxalate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other escitalopram oxalate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Escitalopram Oxalateescitalopram | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4703 | 70518-4703-00 |
| Escitalopram Oxalateescitalopram | Escitalopram oxalate 5 mg/1 | TabletOral | Ascent Pharmaceuticals, Inc | 43602-473 | 43602-0473-1043602-0473-30 |
| Escitalopram Oxalateescitalopram | Escitalopram oxalate 10 mg/1 | TabletOral | Ascent Pharmaceuticals, Inc | 43602-474 | 43602-0474-1043602-0474-30 |
| Escitalopram Oxalateescitalopram | Escitalopram oxalate 20 mg/1 | TabletOral | Ascent Pharmaceuticals, Inc | 43602-475 | 43602-0475-1043602-0475-30 |
| Escitalopram Oxalate | Escitalopram oxalate 20 mg/21 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7200 | 50090-7200-0050090-7200-01 |
| Escitalopram Oxalate | Escitalopram oxalate 20 mg/21 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7201 | 50090-7201-00 |
| Escitalopram Oxalate | Escitalopram oxalate 5 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 72603-149 | 72603-0149-01 |
| Escitalopram Oxalate | Escitalopram oxalate 10 mg/21 | Tablet, Film coatedOral | NorthStar RxLLC | 72603-150 | 72603-0150-01 |
| Escitalopram Oxalate | Escitalopram oxalate 20 mg/21 | Tablet, Film coatedOral | NorthStar RxLLC | 72603-151 | 72603-0151-01 |
| escitalopram oxalate | Escitalopram oxalate 5 mg/1 | TabletOral | Quallent Pharmaceuticals Health LLC | 82009-035 | 82009-0035-10 |
Other NDCs under ANDA 090939
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 |
|---|---|---|---|---|
| escitalopram | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6426 |
| escitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6427 |
| escitalopram | Escitalopram oxalate 5 mg/1 | Tablet, Film coatedOral | Torrent Pharmaceuticals Limited | 13668-135 |
| escitalopram | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | Torrent Pharmaceuticals Limited | 13668-136 |
| escitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | Torrent Pharmaceuticals Limited | 13668-137 |
| escitalopram | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-6893 |
| escitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-7288 |
| escitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4171 |
| escitalopram | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2903 |
| escitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2960 |
| escitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2240 |
| escitalopram | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2241 |
| escitalopram | Escitalopram oxalate 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2242 |
| Escitalopram | Escitalopram oxalate 20 mg/1 | TabletOral | Direct_Rx | 72189-438 |
| escitalopram oxalate | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-761 |
| escitalopram oxalate | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8371 |
| escitalopram oxalate | Escitalopram oxalate 5 mg/1 | TabletOral | Proficient Rx LP | 71205-313 |
| escitalopram oxalate | Escitalopram oxalate 10 mg/1 | TabletOral | Proficient Rx LP | 71205-792 |
| escitalopram oxalate | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0322 |
| escitalopram oxalate | Escitalopram oxalate 5 mg/1 | TabletOral | Quallent Pharmaceuticals Health LLC | 82009-035 |
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