NDC codes

FDA NDC Directory
Product NDC (as listed)0527-1475Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00527-1475Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0527-1475-0100527147501100 TABLET in 1 BOTTLE, PLASTIC (0527-1475-01)Marketed from Jul 18, 2011

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)
Diethylpropion Hydrochloride
Generic name (nonproprietary)
diethylpropion hydrochloride
Active ingredients
Diethylpropion hydrochloride — 25 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Lannett Company, Inc.NDC labeler code 0527
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 200177
Marketing start
Listing expires
DEA schedule
CIV
Other FDA classes
Appetite Suppression (Physiologic effect)Increased Sympathetic Activity (Physiologic effect)
Identifiers
Product ID 0527-1475_cafa73c7-2476-42ab-b1ac-2217aedd9e04SPL ID cafa73c7-2476-42ab-b1ac-2217aedd9e04SPL set ID 4fdbc049-6497-4ea0-8788-d2b2963328f7RxCUI 978654UNII 19V2PL39NG
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

N400527147501 followed by a unit qualifier and the quantity

Package 00527-1475-01. 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 Diethylpropion hydrochloride tablets USP, 25 mg 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 in patients with an initial body mass index (BMI) of 30 kg/m 2 or higher and who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of 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 divided by 2.2 = kg; inches × 0.0254 = meters. Body Mass Index (BMI), kg/m 2 W…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0527-1475

What is NDC 0527-1475?
0527-1475 is the product NDC for Diethylpropion Hydrochloride, Diethylpropion hydrochloride 25 mg/1 tablet, listed with the FDA by Lannett Company, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Diethylpropion Hydrochloride.
What is the active ingredient?
Diethylpropion hydrochloride.
Who is the labeler?
Lannett Company, Inc., NDC labeler code 0527. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Diethylpropion Hydrochloride?
12 other product NDCs are listed under this name. See all Diethylpropion Hydrochloride NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Diethylpropion Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Diethylpropion HydrochlorideDiethylpropion hydrochloride 25 mg/1TabletOralMartek Pharmacal Co.84053-04484053-0044-21
Diethylpropion HydrochlorideDiethylpropion hydrochloride 25 mg/1TabletOralA-S Medication Solutions50090-258050090-2580-0450090-2580-0550090-2580-07+1 more
Diethylpropion HydrochlorideDiethylpropion hydrochloride 25 mg/1TabletOralChartwell RX, LLC.62135-48862135-0488-90
Diethylpropion HydrochlorideDiethylpropion hydrochloride 25 mg/1TabletOralProficient Rx LP63187-94763187-0947-2163187-0947-3063187-0947-60+1 more
Diethylpropion HydrochlorideDiethylpropion hydrochloride 25 mg/1TabletOralBryant Ranch Prepack71335-017571335-0175-0071335-0175-0171335-0175-02+7 more
Diethylpropion HydrochlorideDiethylpropion hydrochloride 25 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-11772789-0117-2872789-0117-90
Diethylpropion HydrochlorideDiethylpropion hydrochloride 25 mg/1TabletOralKVK-TECH, INC10702-04410702-0044-0110702-0044-0310702-0044-06
Diethylpropion HydrochlorideDiethylpropion hydrochloride 25 mg/1TabletOralCalvin Scott & Co., Inc.17224-73017224-0730-2817224-0730-3017224-0730-56+3 more
Diethylpropion HydrochlorideDiethylpropion hydrochloride 25 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.43063-34843063-0348-0143063-0348-0743063-0348-14+7 more
Diethylpropion HydrochlorideDiethylpropion hydrochloride 25 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-340068071-3400-0068071-3400-0168071-3400-02+4 more

All 13 Diethylpropion Hydrochloride NDCs

Other NDCs under ANDA 200177

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 200177
ProductStrengthForm · routeLabelerProduct NDC
Diethylpropion HydrochlorideDiethylpropion hydrochloride 25 mg/1TabletOralA-S Medication Solutions50090-2580
Diethylpropion HydrochlorideDiethylpropion hydrochloride 25 mg/1TabletOralChartwell RX, LLC.62135-488
Diethylpropion HydrochlorideDiethylpropion hydrochloride 25 mg/1TabletOralProficient Rx LP63187-947
Diethylpropion HydrochlorideDiethylpropion hydrochloride 25 mg/1TabletOralBryant Ranch Prepack71335-0175
Diethylpropion HydrochlorideDiethylpropion hydrochloride 25 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-117

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