Glipizide
- Product NDC
- 55289-779
- 11-digit product format
- 552890779
- Labeler code
- 55289
- Product ID
- 55289-779_dabfa0f1-ffb1-f0ee-e053-2a95a90aec9b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glipizide
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA076467
- Marketing category
- ANDA
- Marketing start
- 2003-11-19
- Marketing end
- 0000-00-00
- Substance
- GLIPIZIDE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| GLIPIZIDE | ACTIVE INGREDIENT | X7WDT95N5C | GLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.] | 11 | |
| GLIPIZIDE | ACTIVE MOIETY | X7WDT95N5C | GLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.] | 11 | |
| ACETYLTRIBUTYL CITRATE | INACTIVE INGREDIENT | 0ZBX0N59RZ | GLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.] | 11 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | GLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.] | 11 | |
| BUTYL ALCOHOL | INACTIVE INGREDIENT | 8PJ61P6TS3 | GLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.] | 11 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | GLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.] | 11 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | GLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.] | 11 | |
| HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | INACTIVE INGREDIENT | S38J6RZN16 | GLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.] | 11 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | GLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.] | 11 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | GLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.] | 11 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | GLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.] | 11 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | GLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.] | 11 | |
| METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) | INACTIVE INGREDIENT | 74G4R6TH13 | GLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.] | 11 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | GLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.] | 11 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | GLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.] | 11 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | GLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.] | 11 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55289-779 | GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.] | 26 | Legacy NDC | 20250504_a5edf2f6-0956-403e-9608-e5f3b56b085b.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55289-779-07 | 55289077907 | 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (55289-779-07) | 2013-03-01 | 0000-00-00 | No | No | Current |
| 55289-779-30 | 55289077930 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (55289-779-30) | 2013-03-01 | 0000-00-00 | No | No | Current |
| 55289-779-90 | 55289077990 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (55289-779-90) | 2013-03-01 | 0000-00-00 | No | No | Current |