Prescription drug · ANDA
Duloxetine Delayed-Release (Duloxetine hydrochloride) NDC 70518-0122
Duloxetine hydrochloride 60 mg/1 · Capsule, Delayed release pellets · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-0122-5 | 7051801220570518012205 | 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (70518-0122-5)Marketed from Oct 2, 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)
- Duloxetine Delayed-ReleaseSuffix: Delayed-Release
- Generic name (nonproprietary)
- duloxetine hydrochloride
- Active ingredients
- Duloxetine hydrochloride — 60 mg/1
- Dosage form
- Capsule, Delayed release pellets
- Route
- Oral
- Labeler
- REMEDYREPACK INC.NDC labeler code 70518
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203088
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 70518-0122_54ee31f1-d6fe-dd6b-e063-6394a90a63f0SPL ID 54ee31f1-d6fe-dd6b-e063-6394a90a63f0SPL set ID b9f20917-9529-4c62-bafe-baae7f8d6c77RxCUI 596934UNII 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
N470518012205followed by a unit qualifier and the quantityPackage 70518-0122-05. 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 is 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 70518-0122
- What is NDC 70518-0122?
- 70518-0122 is the product NDC for Duloxetine Delayed-Release (duloxetine hydrochloride), Duloxetine hydrochloride 60 mg/1 capsule, delayed release pellets, listed with the FDA by REMEDYREPACK INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Duloxetine Delayed-Release (Duloxetine hydrochloride).
- What is the active ingredient?
- Duloxetine hydrochloride.
- Who is the labeler?
- REMEDYREPACK INC., NDC labeler code 70518. 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 Delayed-Release?
- 32 other product NDCs are listed under this name. See all Duloxetine Delayed-Release NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Duloxetine Delayed-Release 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 Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 40 mg/1 | Capsule, Delayed release pelletsOral | Preferred Pharmaceuticals Inc. | 68788-8362 | 68788-8362-0068788-8362-0368788-8362-09 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed release pelletsOral | Preferred Pharmaceuticals Inc. | 68788-7897 | 68788-7897-0368788-7897-0668788-7897-09 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 40 mg/1 | Capsule, Delayed release pelletsOral | Breckenridge Pharmaceutical, Inc. | 51991-750 | 51991-0750-0551991-0750-1051991-0750-33+1 more |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 40 mg/1 | Capsule, Delayed release pelletsOral | Bryant Ranch Prepack | 63629-2063 | 63629-2063-01 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 40 mg/1 | Capsule, Delayed release pelletsOral | Bryant Ranch Prepack | 63629-9187 | 63629-9187-01 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 40 mg/1 | Capsule, Delayed release pelletsOral | BluePoint Laboratories | 68001-368 | 68001-0368-04 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 40 mg/1 | Capsule, Delayed release pelletsOral | Bryant Ranch Prepack | 72162-1600 | 72162-1600-03 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 40 mg/1 | Capsule, Delayed release pelletsOral | Proficient Rx LP | 82804-024 | 82804-0024-3082804-0024-6082804-0024-90 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed release pelletsOral | A-S Medication Solutions | 50090-6889 | 50090-6889-0050090-6889-01 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed release pelletsOral | Golden State Medical Supply, Inc. | 51407-817 | 51407-0817-60 |
Other NDCs under ANDA 203088
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 Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed release pelletsOral | Bryant Ranch Prepack | 72162-1597 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 40 mg/1 | Capsule, Delayed release pelletsOral | Bryant Ranch Prepack | 72162-1600 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed release pelletsOral | Bryant Ranch Prepack | 72162-1598 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed release pelletsOral | Bryant Ranch Prepack | 72162-1599 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed release pelletsOral | Bryant Ranch Prepack | 71335-0165 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed release pelletsOral | Breckenridge Pharmaceutical, Inc. | 51991-746 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed release pelletsOral | Breckenridge Pharmaceutical, Inc. | 51991-747 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed release pelletsOral | Breckenridge Pharmaceutical, Inc. | 51991-748 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 40 mg/1 | Capsule, Delayed release pelletsOral | Breckenridge Pharmaceutical, Inc. | 51991-750 |
| Duloxetineduloxetine hydrochloride | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed release pelletsOral | Quallent Pharmaceuticals Health, LLC | 82009-032 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed release pelletsOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-736 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed release pelletsOral | Proficient Rx LP | 63187-702 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed release pelletsOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-739 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed release pelletsOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-743 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed release pelletsOral | Proficient Rx LP | 63187-720 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed release pelletsOral | Proficient Rx LP | 63187-735 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed release pelletsOral | A-S Medication Solutions | 50090-6889 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 40 mg/1 | Capsule, Delayed release pelletsOral | Bryant Ranch Prepack | 63629-9187 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed release pelletsOral | Bryant Ranch Prepack | 71335-0392 |
| Duloxetineduloxetine hydrochloride | Duloxetine hydrochloride 40 mg/1 | Capsule, Delayed release pelletsOral | Quallent Pharmaceuticals Health, LLC | 82009-031 |
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