What is NDC 68308-115?

68308-115 is the product NDC for Methamphetamine Hydrochloride, Methamphetamine hydrochloride 5 mg/1 tablet, listed with the FDA by Mayne Pharma Commercial LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Mayne Pharma Commercial LLC, NDC labeler code 68308. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Methamphetamine Hydrochloride?

2 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Methamphetamine Hydrochloride NDC 68308-115

NDC codes

FDA NDC Directory

Product NDC (as listed)68308-115Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68308-0115Add 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 NDC	11-digit (billing)	Package	Copy
68308-115-01	6830801150168308011501	100 TABLET in 1 BOTTLE, PLASTIC (68308-115-01)Marketed from Apr 26, 2010

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): Methamphetamine Hydrochloride
Generic name (nonproprietary): methamphetamine hydrochloride
Active ingredients: Methamphetamine hydrochloride — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Mayne Pharma Commercial LLCNDC labeler code 68308
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091189
Marketing start: Apr 26, 2010
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Amphetamines (Chemical structure)Appetite Suppression (Physiologic effect)Central Nervous System Stimulation (Physiologic effect)Increased Sympathetic Activity (Physiologic effect)
Identifiers: Product ID 68308-115_ffc2cd39-e42b-5821-e053-6394a90a9974SPL ID ffc2cd39-e42b-5821-e053-6394a90a9974SPL set ID f31f580f-1f08-4a0f-b078-0b9e3308f712RxCUI 977860UNII 997F43Z9CV
Pharmacologic class: Amphetamine Anorectic; Central Nervous System Stimulant

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

N468308011501 followed by a unit qualifier and the quantity

Package 68308-0115-01. 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 Jul 5, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Attention Deficit Disorder with Hyperactivity Methamphetamine hydrochloride tablets are indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children over 6 years of age with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learn…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68308-115

What is NDC 68308-115?: 68308-115 is the product NDC for Methamphetamine Hydrochloride, Methamphetamine hydrochloride 5 mg/1 tablet, listed with the FDA by Mayne Pharma Commercial LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Methamphetamine Hydrochloride.
What is the active ingredient?: Methamphetamine hydrochloride.
Who is the labeler?: Mayne Pharma Commercial LLC, NDC labeler code 68308. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Methamphetamine Hydrochloride?: 2 other product NDCs are listed under this name. See all Methamphetamine 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 Methamphetamine Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Methamphetamine Hydrochloride	Methamphetamine hydrochloride 5 mg/1	TabletOral	Dr. Reddy's Laboratories Inc	75907-094	75907-0094-01
Methamphetamine Hydrochloride	Methamphetamine hydrochloride 5 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc.	0054-0389	00054-0389-25

Other NDCs under ANDA 091189

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

FDA NDC Directory listings under ANDA 091189
Product	Strength	Form · route	Labeler	Product NDC
Methamphetamine Hydrochloride	Methamphetamine hydrochloride 5 mg/1	TabletOral	Dr. Reddy's Laboratories Inc	75907-094