Zafirlukast
- Product NDC
- 68084-059
- 11-digit product format
- 680840059
- Labeler code
- 68084
- Product ID
- 68084-059_2434193f-6ba4-923d-e063-6394a90aec0c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zafirlukast
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA090372
- Marketing category
- ANDA
- Marketing start
- 2013-06-03
- Substance
- ZAFIRLUKAST
- Active strength
- 20 mg/1
- Pharmacologic classes
- Cytochrome P450 2C9 Inhibitors [MoA], Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Zafirlukast
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ZAFIRLUKAST | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | XZ629S5L50 |
| Rxcui | 199655 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68084-059-11 | Zafirlukast | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 7 |
| 68084-059-21 | Zafirlukast | 30 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED | 30 | | 7 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Zafirlukast | ACTIVE INGREDIENT | XZ629S5L50 | ZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 2 | |
| Zafirlukast | ACTIVE MOIETY | XZ629S5L50 | ZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 2 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | ZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 2 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | ZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 2 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | ZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 2 | |
| polyethylene glycol 400 | INACTIVE INGREDIENT | B697894SGQ | ZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | ZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 2 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | ZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68084-059 | ZAFIRLUKAST TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 7 | Current NDC, Legacy NDC, 2 package rows | 20241013_a60f39f6-d590-4b00-8751-7f12b7ec5385.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68084-059-11 | 68084005911 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 68084-059-21 | 68084005921 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-059-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-059-11) | 30 blister pack | 2013-06-03 | 0000-00-00 | No | No | Current |