Prescription drug · NDA
Pristiq Extended-Release (Desvenlafaxine succinate) NDC 0008-1222
Desvenlafaxine succinate 100 mg/1 · Tablet, Extended release · Oral · Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0008-1222-01 | 0000812220100008122201 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0008-1222-01)Marketed from May 1, 2008 | |
| 0008-1222-14 | 0000812221400008122214 | 14 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0008-1222-14)Marketed from May 1, 2008 | |
| 0008-1222-30 | 0000812223000008122230 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0008-1222-30)Marketed from May 1, 2008 | |
| 0008-1222-50 | 0000812225000008122250 | 100 BLISTER PACK in 1 CARTON (0008-1222-50) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from May 1, 2008 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Pristiq Extended-ReleaseSuffix: Extended-Release
- Generic name (nonproprietary)
- desvenlafaxine succinate
- Active ingredients
- Desvenlafaxine succinate — 100 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDC labeler code 0008
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021992
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2D6 Inhibitors (Mechanism)Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 0008-1222_b9acfefd-10c0-4942-9446-18bb456efb68SPL ID b9acfefd-10c0-4942-9446-18bb456efb68SPL set ID 0f43610c-f290-46ea-d186-4f998ed99fceRxCUI 790267, 790290, 1607617, 1607619, 1874553, 1874559UNII ZB22ENF0XRUPC 0300081210306, 0300081222309, 0300081211303
- 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
N400008122201followed by a unit qualifier and the quantityPackage 00008-1222-01. 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)
PRISTIQ is indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14) ] . PRISTIQ is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with major depressive disorder (MDD) ( 1 ).
Excerpt only. Read the full label for complete information.
About NDC 0008-1222
- What is NDC 0008-1222?
- 0008-1222 is the product NDC for Pristiq Extended-Release (desvenlafaxine succinate), Desvenlafaxine succinate 100 mg/1 tablet, extended release, listed with the FDA by Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pristiq Extended-Release (Desvenlafaxine succinate).
- What is the active ingredient?
- Desvenlafaxine succinate.
- Who is the labeler?
- Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., NDC labeler code 0008. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pristiq Extended-Release?
- 2 other product NDCs are listed under this name. See all Pristiq Extended-Release NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Pristiq Extended-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) |
|---|---|---|---|---|---|
| Pristiq Extended-Releasedesvenlafaxine succinate | Desvenlafaxine succinate 25 mg/1 | Tablet, Extended releaseOral | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-1210 | 00008-1210-30 |
| Pristiq Extended-Releasedesvenlafaxine succinate | Desvenlafaxine succinate 50 mg/1 | Tablet, Extended releaseOral | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-1211 | 00008-1211-0100008-1211-1400008-1211-30+1 more |
Other NDCs under NDA 021992
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 |
|---|---|---|---|---|
| Pristiq Extended-Releasedesvenlafaxine succinate | Desvenlafaxine succinate 25 mg/1 | Tablet, Extended releaseOral | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-1210 |
| Pristiq Extended-Releasedesvenlafaxine succinate | Desvenlafaxine succinate 50 mg/1 | Tablet, Extended releaseOral | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-1211 |