Prescription drug · ANDA
Duloxetine Hydrochloride (Duloxetine) NDC 46708-278
Duloxetine hydrochloride 20 mg/1 · Capsule, Delayed release · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-278-30 | 4670802783046708027830 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-278-30)Marketed from Jun 9, 2014 | |
| 46708-278-60 | 4670802786046708027860 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-278-60)Marketed from Jun 9, 2014 | |
| 46708-278-90 | 4670802789046708027890 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-278-90)Marketed from Jun 9, 2014 | |
| 46708-278-91 | 4670802789146708027891 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-278-91)Marketed from Apr 9, 2026 |
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
- Active ingredients
- Duloxetine hydrochloride — 20 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Labeler
- Alembic Pharmaceuticals LimitedNDC labeler code 46708
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202949
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 46708-278_ca40a2f7-7385-41a2-92e6-0b2ddeb89ca5SPL ID ca40a2f7-7385-41a2-92e6-0b2ddeb89ca5SPL set ID 05a744a5-64ef-42d7-a19c-568be5a272d4RxCUI 596926, 596930, 596934UNII 9044SC542WUPC 0346708280307, 0346708279301, 0346708278304
- 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
N446708027830followed by a unit qualifier and the quantityPackage 46708-0278-30. 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 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 adults (1) Fibromyalgia (FM) in adults Chronic muscu…
Excerpt only. Read the full label for complete information.
About NDC 46708-278
- What is NDC 46708-278?
- 46708-278 is the product NDC for Duloxetine Hydrochloride (duloxetine), Duloxetine hydrochloride 20 mg/1 capsule, delayed release, listed with the FDA by Alembic Pharmaceuticals Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Duloxetine Hydrochloride (Duloxetine).
- What is the active ingredient?
- Duloxetine hydrochloride.
- Who is the labeler?
- Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 30 mg/1 | Capsule, Delayed release pelletsOral | Yaopharma Co., Ltd. | 50771-202 | 50771-0202-0150771-0202-02 |
| 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 30 mg/1 | Capsule, Delayed releaseOral | Alembic Pharmaceuticals Limited | 46708-279 | 46708-0279-3046708-0279-9046708-0279-91 |
Other NDCs under ANDA 202949
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 Hydrochlorideduloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed releaseOral | Alembic Pharmaceuticals Limited | 46708-279 |
| Duloxetine Hydrochlorideduloxetine | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed releaseOral | Alembic Pharmaceuticals Limited | 46708-280 |
| Duloxetine Hydrochlorideduloxetine | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed releaseOral | Alembic Pharmaceuticals Inc. | 62332-278 |
| Duloxetine Hydrochlorideduloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed releaseOral | Alembic Pharmaceuticals Inc. | 62332-279 |
| Duloxetine Hydrochlorideduloxetine | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed releaseOral | Alembic Pharmaceuticals Inc. | 62332-280 |