Prescription drug · ANDA

Bupropion Hydrochloride (XL) (bupropion hydrochloride) NDC 43598-656

Bupropion hydrochloride 300 mg/1 · Tablet, Film coated, Extended release · Oral · Dr Reddys Laboratories Inc

NDC codes

FDA NDC Directory
Product NDC (as listed)43598-656Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43598-0656Add 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
43598-656-0543598065605500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43598-656-05)Marketed from Apr 12, 2017
43598-656-304359806563030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43598-656-30)Marketed from Apr 12, 2017
43598-656-904359806569090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43598-656-90)Marketed from Apr 12, 2017

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
Bupropion Hydrochloride (XL)Suffix: (XL)
Generic name (nonproprietary)
bupropion hydrochloride
Active ingredients
Bupropion hydrochloride — 300 mg/1
Dosage form
Tablet, Film coated, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207479
Marketing start
Listing expires
Other FDA classes
Dopamine Uptake Inhibitors (Mechanism)Increased Dopamine Activity (Physiologic effect)Increased Norepinephrine Activity (Physiologic effect)Norepinephrine Uptake Inhibitors (Mechanism)
Identifiers
Product ID 43598-656_9b762c87-96a5-448d-b6d0-b04a1609e2fcSPL ID 9b762c87-96a5-448d-b6d0-b04a1609e2fc
Pharmacologic class
Aminoketone

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

N443598065605 followed by a unit qualifier and the quantity

Package 43598-0656-05. 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

The FDA listing for this product does not reference a label (SPL) set.

Other NDCs under ANDA 207479

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

FDA NDC Directory listings under ANDA 207479
ProductStrengthForm · routeLabelerProduct NDC
Bupropion Hydrochloride (XL)bupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Film coated, Extended releaseOralScieGen Pharmaceuticals,Inc.50228-144
Bupropion Hydrochloride (XL)bupropion hydrochlorideBupropion hydrochloride 300 mg/1Tablet, Film coated, Extended releaseOralScieGen Pharmaceuticals,Inc.50228-145
Bupropion Hydrochloride (XL)bupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack63629-8474
Bupropion Hydrochloride (XL)bupropion hydrochlorideBupropion hydrochloride 300 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack63629-8475
Bupropion Hydrochloride (XL)bupropion hydrochlorideBupropion hydrochloride 300 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack63629-8476
Bupropion Hydrochloride (XL)bupropion hydrochlorideBupropion hydrochloride 300 mg/1Tablet, Film coated, Extended releaseOralREMEDYREPACK INC.70518-3790
Bupropion Hydrochloride (XL)bupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Film coated, Extended releaseOralNuCare Pharmaceuticals, Inc.68071-3927
Bupropion HydrochlorideBupropion hydrochloride 150 mg/1Tablet, Film coated, Extended releaseOralA-S Medication Solutions50090-7711
Bupropion HydrochlorideBupropion hydrochloride 150 mg/1Tablet, Film coated, Extended releaseOralA-S Medication Solutions50090-7712
Bupropion Hydrochloride (XL)bupropion hydrochlorideBupropion hydrochloride 300 mg/1Tablet, Film coated, Extended releaseOralAdvanced Rx of Tennessee, LLC80425-0539
Bupropion Hydrochloride (XL)bupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Film coated, Extended releaseOralREMEDYREPACK INC.70518-3963
Bupropion Hydrochloride (XL)bupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack72162-1526
Bupropion Hydrochloride (XL)bupropion hydrochlorideBupropion hydrochloride 300 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack72162-1527
Bupropion Hydrochloride (XL)bupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Film coated, Extended releaseOralNorthwind Health Company, LLC82868-097
Bupropion Hydrochloride (XL)bupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Film coated, Extended releaseOralDr Reddys Laboratories Inc43598-655
Bupropion HydrochlorideBupropion hydrochloride 150 mg/1Tablet, Film coated, Extended releaseOralCipla USA., Inc.69097-071
Bupropion HydrochlorideBupropion hydrochloride 300 mg/1Tablet, Film coated, Extended releaseOralCipla USA., Inc.69097-072
Bupropion Hydrochloride (XL)bupropion hydrochlorideBupropion hydrochloride 150 mg/1Tablet, Film coated, Extended releaseOralQuality Care Products, LLC83008-082
Bupropion Hydrochloride (XL)bupropion hydrochlorideBupropion hydrochloride 300 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack71335-2312
Bupropion Hydrochloride (XL)bupropion hydrochlorideBupropion hydrochloride 300 mg/1Tablet, Film coated, Extended releaseOralPreferred Pharmaceuticals Inc.68788-4172

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Bupropion Hydrochloride (XL) (bupropion hydrochloride) NDC 43598-656 | Med-Code