Levalbuterol tartrate HFA inhalation
- Product NDC
- 0591-2927
- 11-digit product format
- 005912927
- Labeler code
- 0591
- Product ID
- 0591-2927_f9039b6c-2ae3-416b-bc2a-ab6e06e830bf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levalbuterol tartrate
- Dosage form
- AEROSOL, METERED
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- NDA021730
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2016-10-03
- Substance
- LEVALBUTEROL TARTRATE
- Active strength
- 45 ug/1
- Pharmacologic classes
- Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Levalbuterol tartrate HFA inhalation
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LEVALBUTEROL TARTRATE | 45 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | ADS4I3E22M |
| Rxcui | 745791 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0591-2927-54 | Levalbuterol tartrate HFA inhalation | 1 in 1 CARTON | AEROSOL, METERED | 1 | | 20 |
| 0591-2927-54 | Levalbuterol tartrate HFA inhalation | 200 in 1 INHALER | AEROSOL, METERED | 200 | | 20 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| TETRACYCLINE HYDROCHLORIDE | ACTIVE INGREDIENT | P6R62377KV | TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.] | 3 | |
| TETRACYCLINE | ACTIVE MOIETY | F8VB5M810T | TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.] | 3 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.] | 3 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.] | 3 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.] | 3 | |
| BUTYL ALCOHOL | INACTIVE INGREDIENT | 8PJ61P6TS3 | TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.] | 3 | |
| BUTYLPARABEN | INACTIVE INGREDIENT | 3QPI1U3FV8 | TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.] | 3 | |
| D&C RED NO. 22 | INACTIVE INGREDIENT | 1678RKX8RT | TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.] | 3 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.] | 3 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.] | 3 | |
| EDETATE CALCIUM DISODIUM | INACTIVE INGREDIENT | 25IH6R4SGF | TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.] | 3 | |
| ETHYLENE GLYCOL MONOETHYL ETHER | INACTIVE INGREDIENT | IDK7C2HS09 | TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.] | 3 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.] | 3 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.] | 3 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.] | 3 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.] | 3 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.] | 3 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.] | 3 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.] | 3 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.] | 3 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.] | 3 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.] | 3 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.] | 3 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.] | 3 | |
| SODIUM PROPIONATE | INACTIVE INGREDIENT | DK6Y9P42IN | TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.] | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | TETRACYCLINE HYDROCHLORIDE CAPSULE [WATSON LABORATORIES, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0591-2927 | LEVALBUTEROL TARTRATE HFA INHALATION (LEVALBUTEROL TARTRATE) AEROSOL, METERED [ACTAVIS PHARMA, INC.] | 20 | Current NDC, Legacy NDC, 2 package rows | 20231026_ac85703a-17a2-4f0b-87f4-78f1756d2f85.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 |
|---|
| 0591-2927-54 | 00591292754 | 1 INHALER in 1 CARTON (0591-2927-54) / 200 AEROSOL, METERED in 1 INHALER | 1 inhaler | 2016-10-03 | 0000-00-00 | No | No | Current |