Zafirlukast
- Product NDC
- 55111-625
- 11-digit product format
- 551110625
- Labeler code
- 55111
- Product ID
- 55111-625_b5fb9efb-3369-e1f9-384c-bd22e8ecad92
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zafirlukast
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Dr. Reddys Laboratories Limited
- Application
- ANDA090372
- Marketing category
- ANDA
- Marketing start
- 2010-11-18
- Substance
- ZAFIRLUKAST
- Active strength
- 10 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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | XZ629S5L50 |
| Rxcui | 199655, 313758 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55111-625-01 | Zafirlukast | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 9 |
| 55111-625-05 | Zafirlukast | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 9 |
| 55111-625-30 | Zafirlukast | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 9 |
| 55111-625-60 | Zafirlukast | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 9 |
| 55111-625-78 | Zafirlukast | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 9 |
| 55111-625-79 | Zafirlukast | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Zafirlukast | ACTIVE INGREDIENT | XZ629S5L50 | ZAFIRLUKAST TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] | 4 | |
| Zafirlukast | ACTIVE MOIETY | XZ629S5L50 | ZAFIRLUKAST TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ZAFIRLUKAST TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] | 4 | |
| hydroxypropyl cellulose | INACTIVE INGREDIENT | RFW2ET671P | ZAFIRLUKAST TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] | 4 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | ZAFIRLUKAST TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] | 4 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | ZAFIRLUKAST TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] | 4 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | ZAFIRLUKAST TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] | 4 | |
| polyethylene glycol 400 | INACTIVE INGREDIENT | B697894SGQ | ZAFIRLUKAST TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] | 4 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | ZAFIRLUKAST TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] | 4 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | ZAFIRLUKAST TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55111-625 | ZAFIRLUKAST TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] | 9 | Current NDC, Legacy NDC, 6 package rows | 20190312_6ccb96af-2647-9206-5eee-49a825d32488.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 |
|---|
| 55111-625-01 | 55111062501 | 100 TABLET, FILM COATED in 1 BOTTLE (55111-625-01) | | 2010-11-18 | 0000-00-00 | No | No | Current |
| 55111-625-05 | 55111062505 | 500 TABLET, FILM COATED in 1 BOTTLE (55111-625-05) | | 2010-11-18 | 0000-00-00 | No | No | Current |
| 55111-625-30 | 55111062530 | 30 TABLET, FILM COATED in 1 BOTTLE (55111-625-30) | | 2010-11-18 | 0000-00-00 | No | No | Current |
| 55111-625-60 | 55111062560 | 60 TABLET, FILM COATED in 1 BOTTLE (55111-625-60) | | 2010-11-18 | 0000-00-00 | No | No | Current |
| 55111-625-78 | 55111062578 | 10 BLISTER PACK in 1 CARTON (55111-625-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-625-79) | 10 blister pack | 2010-11-18 | 0000-00-00 | No | No | Current |
| 55111-625-79 | 55111062579 | 10 in 1 BLISTER PACK | | | | | | Historical |