Prescription drug · ANDA
Benzphetamine Hydrochloride NDC 71335-0451
Benzphetamine hydrochloride 50 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-0451-1 | 7133504510171335045101 | 30 TABLET in 1 BOTTLE (71335-0451-1)Marketed from Aug 17, 2018 | |
| 71335-0451-2 | 7133504510271335045102 | 7 TABLET in 1 BOTTLE (71335-0451-2)Marketed from Jul 25, 2018 | |
| 71335-0451-3 | 7133504510371335045103 | 14 TABLET in 1 BOTTLE (71335-0451-3)Marketed from Jul 25, 2018 | |
| 71335-0451-4 | 7133504510471335045104 | 21 TABLET in 1 BOTTLE (71335-0451-4)Marketed from Sep 14, 2018 | |
| 71335-0451-5 | 7133504510571335045105 | 42 TABLET in 1 BOTTLE (71335-0451-5)Marketed from Apr 23, 2018 | |
| 71335-0451-6 | 7133504510671335045106 | 84 TABLET in 1 BOTTLE (71335-0451-6)Marketed from May 29, 2024 | |
| 71335-0451-7 | 7133504510771335045107 | 60 TABLET in 1 BOTTLE (71335-0451-7)Marketed from Jul 10, 2018 | |
| 71335-0451-8 | 7133504510871335045108 | 90 TABLET in 1 BOTTLE (71335-0451-8)Marketed from Feb 12, 2018 | |
| 71335-0451-9 | 7133504510971335045109 | 120 TABLET in 1 BOTTLE (71335-0451-9)Marketed from May 29, 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)
- Benzphetamine Hydrochloride
- Generic name (nonproprietary)
- benzphetamine hydrochloride
- Active ingredients
- Benzphetamine hydrochloride — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 71335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090968
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Appetite Suppression (Physiologic effect)Increased Sympathetic Activity (Physiologic effect)
- Identifiers
- Product ID 71335-0451_98aa03d7-8df0-4b01-8371-9761a0176afaSPL ID 98aa03d7-8df0-4b01-8371-9761a0176afaSPL set ID 1c726aa7-3b78-45de-aca0-fd8a5fff9403RxCUI 904368UNII 43DWT87QT7
- 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
N471335045101followed by a unit qualifier and the quantityPackage 71335-0451-01. 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 Benzphetamine hydrochloride tablets are indicated in the management of exogenous obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds ÷2.2 = kg; inches × 0.0254 = meters. The limited usefulness of agents of this…
Excerpt only. Read the full label for complete information.
About NDC 71335-0451
- What is NDC 71335-0451?
- 71335-0451 is the product NDC for Benzphetamine Hydrochloride, Benzphetamine hydrochloride 50 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 9 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Benzphetamine Hydrochloride.
- What is the active ingredient?
- Benzphetamine hydrochloride.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 71335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Benzphetamine Hydrochloride?
- 5 other product NDCs are listed under this name. See all Benzphetamine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Benzphetamine 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) |
|---|---|---|---|---|---|
| Benzphetamine Hydrochloride | Benzphetamine hydrochloride 50 mg/1 | Tablet, Film coatedOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-952 | 23155-0952-0123155-0952-0323155-0952-05 |
| Benzphetamine Hydrochloride | Benzphetamine hydrochloride 50 mg/1 | Tablet, Film coatedOral | Epic Pharma, LLC | 42806-081 | 42806-0081-0142806-0081-0542806-0081-30 |
| Benzphetamine Hydrochloride | Benzphetamine hydrochloride 50 mg/1 | TabletOral | KVK-TECH, INC | 10702-040 | 10702-0040-0110702-0040-0310702-0040-10+1 more |
| Benzphetamine Hydrochloride | Benzphetamine hydrochloride 50 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-541 | 43063-0541-1443063-0541-3043063-0541-45+3 more |
| benzphetamine hydrochloride | Benzphetamine hydrochloride 50 mg/1 | TabletOral | Calvin Scott & Co., Inc. | 17224-672 | 17224-0672-3017224-0672-60 |
Other NDCs under ANDA 090968
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 |
|---|---|---|---|---|
| Benzphetamine Hydrochloride | Benzphetamine hydrochloride 50 mg/1 | TabletOral | KVK-TECH, INC | 10702-040 |
| benzphetamine hydrochloride | Benzphetamine hydrochloride 50 mg/1 | TabletOral | Calvin Scott & Co., Inc. | 17224-672 |
| Benzphetamine Hydrochloride | Benzphetamine hydrochloride 50 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-541 |