Prescription drug · ANDA
Mirtazapine NDC 17856-0101
Mirtazapine 7.5 mg/1 · Tablet, Film coated · Oral · ATLANTIC BIOLOGICALS CORP.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 17856-0101-1 | 1785601010117856010101 | 100 POUCH in 1 BOX, UNIT-DOSE (17856-0101-1) / 1 TABLET, FILM COATED in 1 POUCHMarketed from May 12, 2021 |
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)
- Mirtazapine
- Generic name (nonproprietary)
- mirtazapine
- Active ingredients
- Mirtazapine — 7.5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- ATLANTIC BIOLOGICALS CORP.NDC labeler code 17856
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076921
- Marketing start
- Listing expires
- Identifiers
- Product ID 17856-0101_3892e59b-daa3-17b8-e063-6394a90a00f5SPL ID 3892e59b-daa3-17b8-e063-6394a90a00f5SPL set ID e6e5cbf7-a958-4ef8-abcc-a7491edb9520RxCUI 476809UNII A051Q2099Q
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
N417856010101followed by a unit qualifier and the quantityPackage 17856-0101-01. 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)
INDICATIONS AND USAGE Mirtazapine tablets are indicated for the treatment of major depressive disorder. The efficacy of mirtazapine in the treatment of major depressive disorder was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the Diagnostic and Statistical Manual of Mental Disorders-3rd edition (DSM-III) category of major depressive disorder (see CLINICAL PHARMACOLOGY ). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, los…
Excerpt only. Read the full label for complete information.
About NDC 17856-0101
- What is NDC 17856-0101?
- 17856-0101 is the product NDC for Mirtazapine, Mirtazapine 7.5 mg/1 tablet, film coated, listed with the FDA by ATLANTIC BIOLOGICALS CORP.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Mirtazapine.
- What is the active ingredient?
- Mirtazapine.
- Who is the labeler?
- ATLANTIC BIOLOGICALS CORP., NDC labeler code 17856. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Mirtazapine?
- 138 other product NDCs are listed under this name. See all Mirtazapine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Mirtazapine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0319 | 67046-0319-03 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-0280 | 55154-0280-00 |
| Mirtazapine | Mirtazapine 7.5 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0625 | 67046-0625-03 |
| Mirtazapine | Mirtazapine 45 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-2024 | 67046-2024-03 |
| Mirtazapine | Mirtazapine 7.5 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8663 | 00615-8663-0500615-8663-39 |
| Mirtazapine | Mirtazapine 7.5 mg/1 | Tablet, Film coatedOral | ANI Pharmaceuticals, Inc. | 70954-830 | 70954-0830-10 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0484 | 67046-0484-03 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0068 | 67046-0068-03 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Film coatedOral | Safecor Health LLC | 48433-077 | 48433-0077-20 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | Safecor Health LLC | 48433-076 | 48433-0076-20 |
Other NDCs under ANDA 076921
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 |
|---|---|---|---|---|
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, Inc dba Vangard Labs | 0615-8268 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, Inc dba Vangard Labs | 0615-8269 |
| Mirtazapine | Mirtazapine 7.5 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8489 |
| Mirtazapine | Mirtazapine 7.5 mg/1 | Tablet, Film coatedOral | Aurolife Pharma LLC | 13107-001 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Film coatedOral | Aurolife Pharma LLC | 13107-003 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | Aurolife Pharma LLC | 13107-031 |
| Mirtazapine | Mirtazapine 45 mg/1 | Tablet, Film coatedOral | Aurolife Pharma LLC | 13107-032 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-2140 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-2558 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-2800 |
| Mirtazapine | Mirtazapine 7.5 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-007 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-008 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-009 |
| Mirtazapine | Mirtazapine 45 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-010 |
| Mirtazapine | Mirtazapine 7.5 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-584 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-403 |
| Mirtazapine | Mirtazapine 45 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-3346 |
| Mirtazapine | Mirtazapine 7.5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-9255 |
| Mirtazapine | Mirtazapine 30 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-003 |
| Mirtazapine | Mirtazapine 15 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-031 |
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