Prescription drug · ANDA
Duloxetine NDC 76420-633
Duloxetine hydrochloride 20 mg/1 · Capsule, Delayed release · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-633-00 | 7642006330076420063300 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-633-00)Marketed from Apr 3, 2025 | |
| 76420-633-01 | 7642006330176420063301 | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-633-01)Marketed from Oct 17, 2023 | |
| 76420-633-05 | 7642006330576420063305 | 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-633-05)Marketed from Apr 3, 2025 | |
| 76420-633-20 | 7642006332076420063320 | 20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-633-20)Marketed from Apr 3, 2025 | |
| 76420-633-30 | 7642006333076420063330 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-633-30)Marketed from Oct 17, 2023 | |
| 76420-633-60 | 7642006336076420063360 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-633-60)Marketed from Oct 17, 2023 | |
| 76420-633-90 | 7642006339076420063390 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-633-90)Marketed from Oct 17, 2023 |
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)
- Duloxetine
- Generic name (nonproprietary)
- duloxetine
- Active ingredients
- Duloxetine hydrochloride — 20 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Labeler
- Asclemed USA, Inc.NDC labeler code 76420
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208706
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 76420-633_31e2603c-b629-1f0d-e063-6294a90a3646SPL ID 31e2603c-b629-1f0d-e063-6294a90a3646SPL set ID f61bd9f3-cd3d-4c76-a110-0f1dcba610afRxCUI 596926, 596930, 596934, 616402UNII 9044SC542W
- Pharmacologic class
- Serotonin and Norepinephrine 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
N476420063300followed by a unit qualifier and the quantityPackage 76420-0633-00. 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)
Duloxetine delayed-release capsules are indicated for the treatment of: Major depressive disorder in adults Generalized anxiety disorder in adults and pediatric patients 7 years of age and older Diabetic peripheral neuropathic pain in adults Fibromyalgia in adults and pediatric patients 13 years of age and older Chronic musculoskeletal pain in adults Duloxetine delayed-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the following conditions: Major depressive disorder (MDD) in adults ( 1 ) Generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older ( 1 ) Diabetic peripheral neuropathic pain (DPNP) in…
Excerpt only. Read the full label for complete information.
About NDC 76420-633
- What is NDC 76420-633?
- 76420-633 is the product NDC for Duloxetine, Duloxetine hydrochloride 20 mg/1 capsule, delayed release, listed with the FDA by Asclemed USA, Inc.. It has 7 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Duloxetine.
- What is the active ingredient?
- Duloxetine hydrochloride.
- Who is the labeler?
- Asclemed USA, Inc., NDC labeler code 76420. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Duloxetine?
- 140 other product NDCs are listed under this name. See all Duloxetine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Duloxetine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Duloxetine | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed releaseOral | ANI Pharmaceuticals, Inc. | 70954-860 | 70954-0860-30 |
| Duloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed releaseOral | ANI Pharmaceuticals, Inc. | 70954-861 | 70954-0861-20 |
| Duloxetine | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed releaseOral | ANI Pharmaceuticals, Inc. | 70954-864 | 70954-0864-20 |
| Duloxetine | Duloxetine hydrochloride 120 mg/1 | Capsule, Delayed releaseOral | Almatica Pharma LLC | 52427-791 | 52427-0791-30 |
| Duloxetine | Duloxetine hydrochloride 80 mg/1 | Capsule, Delayed releaseOral | Almatica Pharma LLC | 52427-821 | 52427-0821-30 |
| Duloxetine | Duloxetine hydrochloride 90 mg/1 | Capsule, Delayed releaseOral | Almatica Pharma LLC | 52427-913 | 52427-0913-30 |
| Duloxetine | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed releaseOral | Preferred Pharmaceuticals Inc. | 68788-4128 | 68788-4128-0368788-4128-0668788-4128-09 |
| Duloxetine | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed releaseOral | Coupler LLC | 67046-1598 | 67046-1598-03 |
| Duloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed releaseOral | Coupler LLC | 67046-1585 | 67046-1585-03 |
| Duloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed release pelletsOral | Preferred Phamaceuticals Inc. | 68788-4025 | 68788-4025-0368788-4025-0668788-4025-09 |
Other NDCs under ANDA 208706
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 |
|---|---|---|---|---|
| Duloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed releaseOral | HAWAII REPACK, INC. | 85534-0052 |
| Duloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed releaseOral | Preferred Pharmaceuticals Inc. | 68788-7935 |
| Duloxetine | Duloxetine hydrochloride 40 mg/1 | Capsule, Delayed releaseOral | HAWAII REPACK, INC. | 85534-0053 |
| Duloxetine HCL DRduloxetine hcl | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed releaseOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0146 |
| Duloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed releaseOral | Coupler LLC | 67046-1451 |
| Duloxetine | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed releaseOral | Asclemed USA, Inc. | 76420-623 |
| Duloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-954 |
| Duloxetine | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-403 |
| Duloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 71335-2017 |
| Duloxetine | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 71335-3062 |
| Duloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed releaseOral | ASCLEMED USA INC. | 87063-703 |
| Duloxetine | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed releaseOral | ASCLEMED USA INC. | 87063-702 |
| Duloxetine | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed releaseOral | St. Mary's Medical Park Pharmacy | 60760-759 |
| Duloxetine | Duloxetine hydrochloride 40 mg/1 | Capsule, Delayed releaseOral | ASCLEMED USA INC. | 87063-704 |
| Duloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed releaseOral | Proficient Rx LP | 71205-602 |
| Duloxetine | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed releaseOral | Proficient Rx LP | 71205-005 |
| Duloxetine | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed releaseOral | REMEDYREPACK INC. | 70518-1011 |
| Duloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed releaseOral | REMEDYREPACK INC. | 70518-1054 |
| Duloxetine | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed releaseOral | REMEDYREPACK INC. | 70518-1139 |
| Duloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed releaseOral | REMEDYREPACK INC. | 70518-3287 |
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