Prescription drug · ANDA
Duloxetine Hydrochloride NDC 50771-202
Duloxetine hydrochloride 30 mg/1 · Capsule, Delayed release pellets · Oral · Yaopharma Co., Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50771-202-01 | 5077102020150771020201 | 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (50771-202-01)Marketed from Jan 1, 2024 | |
| 50771-202-02 | 5077102020250771020202 | 1000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (50771-202-02)Marketed from Jan 1, 2024 |
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 Hydrochloride
- Generic name (nonproprietary)
- duloxetine hydrochloride
- Active ingredients
- Duloxetine hydrochloride — 30 mg/1
- Dosage form
- Capsule, Delayed release pellets
- Route
- Oral
- Labeler
- Yaopharma Co., Ltd.NDC labeler code 50771
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207219
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 50771-202_5611fb30-bf39-7dae-e063-6294a90a08edSPL ID 5611fb30-bf39-7dae-e063-6294a90a08edSPL set ID 90224073-178d-7ec5-e053-2995a90a20fcRxCUI 596926, 596930, 596934UNII 9044SC542WUPC 0350771203019, 0350771202012, 0350771201015
- 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
N450771020201followed by a unit qualifier and the quantityPackage 50771-0202-01. 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)
Duloxetine delayed-release capsules, USP are indicated for the treatment of: • Major Depressive Disorder [see Clinical Studies ( 14.1 )] • Generalized Anxiety Disorder [see Clinical Studies ( 14.2 )] • Diabetic Peripheral Neuropathy [see Clinical Studies ( 14.3 )] • Chronic Musculoskeletal Pain [see Clinical Studies ( 14.5 )]
Excerpt only. Read the full label for complete information.
About NDC 50771-202
- What is NDC 50771-202?
- 50771-202 is the product NDC for Duloxetine Hydrochloride, Duloxetine hydrochloride 30 mg/1 capsule, delayed release pellets, listed with the FDA by Yaopharma Co., Ltd.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Duloxetine Hydrochloride.
- What is the active ingredient?
- Duloxetine hydrochloride.
- Who is the labeler?
- Yaopharma Co., Ltd., NDC labeler code 50771. 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 Hydrochloride?
- 11 other product NDCs are listed under this name. See all Duloxetine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Duloxetine Hydrochloride 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 Hydrochlorideduloxetine | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed releaseOral | Alembic Pharmaceuticals Inc. | 62332-278 | 62332-0278-3062332-0278-6062332-0278-90+1 more |
| Duloxetine Hydrochlorideduloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed releaseOral | Alembic Pharmaceuticals Inc. | 62332-279 | 62332-0279-3062332-0279-9062332-0279-91 |
| Duloxetine Hydrochlorideduloxetine | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed releaseOral | Alembic Pharmaceuticals Inc. | 62332-280 | 62332-0280-3062332-0280-9062332-0280-91 |
| Duloxetine Hydrochloride | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed release pelletsOral | Yaopharma Co., Ltd. | 50771-201 | 50771-0201-01 |
| Duloxetine Hydrochloride | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed release pelletsOral | Yaopharma Co., Ltd. | 50771-203 | 50771-0203-0150771-0203-02 |
| Duloxetine Hydrochloride | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed releaseOral | Macleods Pharmaceuticals Limited | 33342-160 | 33342-0160-0933342-0160-1033342-0160-12+1 more |
| Duloxetine Hydrochloride | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed releaseOral | Macleods Pharmaceuticals Limited | 33342-161 | 33342-0161-0733342-0161-1033342-0161-12+1 more |
| Duloxetine Hydrochloride | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed releaseOral | Macleods Pharmaceuticals Limited | 33342-162 | 33342-0162-0733342-0162-1033342-0162-12+1 more |
| Duloxetine Hydrochlorideduloxetine | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed releaseOral | Alembic Pharmaceuticals Limited | 46708-278 | 46708-0278-3046708-0278-6046708-0278-90+1 more |
| Duloxetine Hydrochlorideduloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed releaseOral | Alembic Pharmaceuticals Limited | 46708-279 | 46708-0279-3046708-0279-9046708-0279-91 |
Other NDCs under ANDA 207219
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 Hydrochloride | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed release pelletsOral | Yaopharma Co., Ltd. | 50771-201 |
| Duloxetine Hydrochloride | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed release pelletsOral | Yaopharma Co., Ltd. | 50771-203 |