NDC codes

FDA NDC Directory
Product NDC (as listed)66993-822Labeler and product segments. Claims need a package NDC.
Product NDC at billing width66993-0822Add 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
66993-822-30669930822306699308223030 TABLET in 1 BOTTLE (66993-822-30)Marketed from Aug 4, 2015

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)
pioglitazone and glimepiride
Generic name (nonproprietary)
pioglitazone and glimepiride
Active ingredients
Pioglitazone hydrochloride — 30 mg/1Glimepiride — 4 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Prasco LaboratoriesNDC labeler code 66993
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 021925
Marketing start
Listing expires
Other FDA classes
Peroxisome Proliferator-activated Receptor alpha Agonists (Mechanism)Peroxisome Proliferator-activated Receptor gamma Agonists (Mechanism)Sulfonylurea Compounds (Chemical structure)Thiazolidinediones (Chemical structure)
Identifiers
Product ID 66993-822_370e643e-7cf8-4a0a-b6c4-78e96162c48fSPL ID 370e643e-7cf8-4a0a-b6c4-78e96162c48fSPL set ID ea385b3d-cb4c-4550-97b0-93a86533f6dcRxCUI 647237, 647239UNII JQT35NPK6C, 6KY687524KUPC 0366993822303, 0366993821306
Pharmacologic class
Peroxisome Proliferator Receptor alpha Agonist; Peroxisome Proliferator Receptor gamma Agonist; Sulfonylurea; Thiazolidinedione

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

N466993082230 followed by a unit qualifier and the quantity

Package 66993-0822-30. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Pioglitazone and glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a thiazolidinedione and sulfonylurea or who have inadequate glycemic control on a thiazolidinedione alone or a sulfonylurea alone [see Clinical Studies (14) ] . Pioglitazone and glimepiride tablets are a thiazolidinedione and a sulfonylurea combination product indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both pioglitazone and glimepiride is appropriate. ( 1 ) Important Limitations of Use: Not for treatment of type 1 diabetes …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 66993-822

What is NDC 66993-822?
66993-822 is the product NDC for pioglitazone and glimepiride, Pioglitazone hydrochloride 30 mg/1; Glimepiride 4 mg/1 tablet, listed with the FDA by Prasco Laboratories. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
pioglitazone and glimepiride.
What is the active ingredient?
Pioglitazone hydrochloride, Glimepiride.
Who is the labeler?
Prasco Laboratories, NDC labeler code 66993. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for pioglitazone and glimepiride?
1 other product NDC are listed under this name. See all pioglitazone and glimepiride 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 pioglitazone and glimepiride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
pioglitazone and glimepiridePioglitazone hydrochloride 30 mg/1; Glimepiride 2 mg/1TabletOralPrasco Laboratories66993-82166993-0821-30

Other NDCs under NDA 021925

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

FDA NDC Directory listings under NDA 021925
ProductStrengthForm · routeLabelerProduct NDC
Duetactpioglitazone and glimepiridePioglitazone hydrochloride 30 mg/1; Glimepiride 2 mg/1TabletOralTakeda Pharmaceuticals America, Inc.64764-302
Duetactpioglitazone and glimepiridePioglitazone hydrochloride 30 mg/1; Glimepiride 4 mg/1TabletOralTakeda Pharmaceuticals America, Inc.64764-304
pioglitazone and glimepiridePioglitazone hydrochloride 30 mg/1; Glimepiride 2 mg/1TabletOralPrasco Laboratories66993-821

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