What is NDC 69367-305?

69367-305 is the product NDC for Miglitol, Miglitol 100 mg/1 tablet, coated, listed with the FDA by Westminster Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Westminster Pharmaceuticals, LLC, NDC labeler code 69367. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Miglitol?

5 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Miglitol NDC 69367-305 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69367-305Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69367-0305Add 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
69367-305-01	69367030501	100 TABLET, COATED in 1 BOTTLE (69367-305-01)Marketed from Jan 15, 2021

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): Miglitol
Generic name (nonproprietary): miglitol
Active ingredients: Miglitol — 100 mg/1
Dosage form: Tablet, Coated
Route: Oral
Labeler: Westminster Pharmaceuticals, LLCNDC labeler code 69367
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203965
Marketing start: Jan 15, 2021
Listing expires: Dec 31, 2026
Other FDA classes: alpha Glucosidase Inhibitors (Mechanism)
Identifiers: Product ID 69367-305_d28d00da-e102-098c-e053-2995a90a8121SPL ID d28d00da-e102-098c-e053-2995a90a8121SPL set ID b8da2015-d254-2425-e053-2995a90acf0eRxCUI 205329, 205330, 205331UNII 0V5436JAQWUPC 0369367303019, 0369367304016, 0369367305013
Pharmacologic class: alpha-Glucosidase Inhibitor

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

N469367030501 followed by a unit qualifier and the quantity

Package 69367-0305-01. 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 Dec 7, 2021.

Indications (excerpt from the label)

INDICATIONS AND USAGE Miglitol tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69367-305

What is NDC 69367-305?: 69367-305 is the product NDC for Miglitol, Miglitol 100 mg/1 tablet, coated, listed with the FDA by Westminster Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Miglitol.
What is the active ingredient?: Miglitol.
Who is the labeler?: Westminster Pharmaceuticals, LLC, NDC labeler code 69367. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Miglitol?: 5 other product NDCs are listed under this name. See all Miglitol 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 Miglitol NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Miglitol	Miglitol 50 mg/1	Tablet, CoatedOral	Proficient Rx LP	71205-936	71205-0936-0071205-0936-3071205-0936-60+1 more
Miglitol	Miglitol 25 mg/1	Tablet, CoatedOral	Proficient Rx LP	71205-935	71205-0935-0071205-0935-3071205-0935-60+1 more
Miglitol	Miglitol 100 mg/1	Tablet, CoatedOral	Proficient Rx LP	71205-937	71205-0937-0071205-0937-3071205-0937-60+1 more
Miglitol	Miglitol 25 mg/1	Tablet, CoatedOral	Westminster Pharmaceuticals, LLC	69367-303	69367-0303-01
Miglitol	Miglitol 50 mg/1	Tablet, CoatedOral	Westminster Pharmaceuticals, LLC	69367-304	69367-0304-01

Other NDCs under ANDA 203965

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

FDA NDC Directory listings under ANDA 203965
Product	Strength	Form · route	Labeler	Product NDC
Miglitol	Miglitol 50 mg/1	Tablet, CoatedOral	Proficient Rx LP	71205-936
Miglitol	Miglitol 25 mg/1	Tablet, CoatedOral	Proficient Rx LP	71205-935
Miglitol	Miglitol 100 mg/1	Tablet, CoatedOral	Proficient Rx LP	71205-937
Miglitol	Miglitol 25 mg/1	Tablet, CoatedOral	Westminster Pharmaceuticals, LLC	69367-303
Miglitol	Miglitol 50 mg/1	Tablet, CoatedOral	Westminster Pharmaceuticals, LLC	69367-304