NDC codes

FDA NDC Directory
Product NDC (as listed)0406-8952Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00406-8952Add 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
0406-8952-0100406895201100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-8952-01)Marketed from Apr 22, 2019

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)
Mixed Salts of a Single Entity Amphetamine Product XRSuffix: XR
Generic name (nonproprietary)
dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate
Active ingredients
Dextroamphetamine sulfate — 2.5 mg/1Dextroamphetamine saccharate — 2.5 mg/1Amphetamine aspartate monohydrate — 2.5 mg/1Amphetamine sulfate — 2.5 mg/1
Dosage form
Capsule, Extended release
Route
Oral
Labeler
SpecGx LLC
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211547
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Central Nervous System Stimulation (Physiologic effect)Central Nervous System Stimulation (Physiologic effect)Central Nervous System Stimulation (Physiologic effect)Central Nervous System Stimulation (Physiologic effect)
Identifiers
Product ID 0406-8952_d35f2f82-b0de-4f2a-a740-3d95c364cd7bSPL ID d35f2f82-b0de-4f2a-a740-3d95c364cd7bSPL set ID 60a2834c-38a2-480e-b89c-563e9cf0c9c3RxCUI 861221, 861223, 861225, 861227, 861232, 861237UNII JJ768O327N, O1ZPV620O4, 6DPV8NK46S, G83415V073UPC 0304068956010, 0304068955013

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

N400406895201 followed by a unit qualifier and the quantity

Package 00406-8952-01. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 211547

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

FDA NDC Directory listings under ANDA 211547
ProductStrengthForm · routeLabelerProduct NDC
Mixed Salts of a Single Entity Amphetamine Product XRdextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfateDextroamphetamine sulfate 6.25 mg/1 + 3 more ingredientsCapsule, Extended releaseOralSpecGx LLC0406-8955
Mixed Salts of a Single Entity Amphetamine Product XRdextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfateDextroamphetamine sulfate 7.5 mg/1 + 3 more ingredientsCapsule, Extended releaseOralSpecGx LLC0406-8956
Mixed Salts of a Single Entity Amphetamine Product XRdextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfateDextroamphetamine sulfate 1.25 mg/1 + 3 more ingredientsCapsule, Extended releaseOralSpecGx LLC0406-8951
Mixed Salts of a Single Entity Amphetamine Product XRdextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfateDextroamphetamine sulfate 3.75 mg/1 + 3 more ingredientsCapsule, Extended releaseOralSpecGx LLC0406-8953
Mixed Salts of a Single Entity Amphetamine Product XRdextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfateDextroamphetamine sulfate 5 mg/1 + 3 more ingredientsCapsule, Extended releaseOralSpecGx LLC0406-8954

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