Prescription drug · ANDA
Phendimetrazine Tartrate NDC 63629-2489
Phendimetrazine tartrate 35 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-2489-1 | 63629248901 | 1000 TABLET in 1 BOTTLE (63629-2489-1)Marketed from Jul 1, 2018 |
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)
- Phendimetrazine Tartrate
- Generic name (nonproprietary)
- phendimetrazine tartrate
- Active ingredients
- Phendimetrazine tartrate — 35 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 085588
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Appetite Suppression (Physiologic effect)Increased Sympathetic Activity (Physiologic effect)
- Identifiers
- Product ID 63629-2489_cab79dee-1fc7-4dcf-99d4-5a9af4053340SPL ID cab79dee-1fc7-4dcf-99d4-5a9af4053340SPL set ID 75f6c4bc-ed72-498a-822c-ecc2a13df958RxCUI 979549UNII 6985IP0T80
- Pharmacologic class
- Sympathomimetic Amine Anorectic
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
N463629248901followed by a unit qualifier and the quantityPackage 63629-2489-01. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Phendimetrazine tartrate tablets are indicated in the management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction. The limited usefulness of agents of this class (see CLINICAL PHARMACOLOGY ) should be measured against possible risk factors inherent in their use such as those described below.
Excerpt only. Read the full label for complete information.
About NDC 63629-2489
- What is NDC 63629-2489?
- 63629-2489 is the product NDC for Phendimetrazine Tartrate, Phendimetrazine tartrate 35 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Phendimetrazine Tartrate.
- What is the active ingredient?
- Phendimetrazine tartrate.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 63629. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Phendimetrazine Tartrate?
- 19 other product NDCs are listed under this name. See all Phendimetrazine Tartrate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Phendimetrazine Tartrate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Phendimetrazine Tartrate | Phendimetrazine tartrate 105 mg/1 | Capsule, Extended releaseOral | Acertis Pharmaceuticals, LLC | 72989-409 | 72989-0409-30 |
| Phendimetrazine Tartrate | Phendimetrazine tartrate 35 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7236 | 68788-7236-0168788-7236-0268788-7236-03+1 more |
| Phendimetrazine Tartrate | Phendimetrazine tartrate 35 mg/1 | TabletOral | Virtus Pharmaceuticals, LLC | 69543-410 | 69543-0410-10 |
| Phendimetrazine Tartrate | Phendimetrazine tartrate 35 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1840 | 71335-1840-0071335-1840-0171335-1840-02+7 more |
| Phendimetrazine Tartrate | Phendimetrazine tartrate 35 mg/1 | TabletOral | Elite Laboratories, Inc | 64850-440 | 64850-0440-0164850-0440-10 |
| Phendimetrazine Tartrate | Phendimetrazine tartrate 35 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3509 | 68071-3509-0168071-3509-0668071-3509-08+1 more |
| Phendimetrazine Tartrate | Phendimetrazine tartrate 35 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2044 | 72162-2044-0072162-2044-0172162-2044-03+1 more |
| Phendimetrazine Tartrate | Phendimetrazine tartrate 35 mg/1 | TabletOral | KVK-TECH, INC | 10702-045 | 10702-0045-0110702-0045-0310702-0045-10 |
| Phendimetrazine Tartrate | Phendimetrazine tartrate 35 mg/1 | TabletOral | KVK-TECH, INC | 10702-077 | 10702-0077-0110702-0077-0310702-0077-10 |
| Phendimetrazine Tartrate | Phendimetrazine tartrate 35 mg/1 | TabletOral | KVK-TECH, INC | 10702-078 | 10702-0078-0110702-0078-0310702-0078-10 |
Other NDCs under ANDA 085588
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 |
|---|---|---|---|---|
| Phendimetrazine Tartrate | Phendimetrazine tartrate 35 mg/1 | TabletOral | Virtus Pharmaceuticals, LLC | 69543-410 |
| Phendimetrazine Tartrate | Phendimetrazine tartrate 35 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1840 |