levalbuterol inhalation
- Product NDC
- 43598-410
- 11-digit product format
- 435980410
- Labeler code
- 43598
- Product ID
- 43598-410_3ec07be3-1e04-66a2-ffee-b4795006fae9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levalbuterol inhalation 0.63mg/3mL
- Dosage form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Dr. Reddy
- Application
- ANDA078171
- Marketing category
- ANDA
- Marketing start
- 2014-09-16
- Marketing end
- 0000-00-00
- Substance
- LEVALBUTEROL
- Active strength
- 1 mg/3mL
- Pharmacologic classes
- Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 43598-410 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 43598-410 | 43598-410-25 | D | Discontinued by firm | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A078171-001 | LEVALBUTEROL HYDROCHLORIDE | LEVALBUTEROL HYDROCHLORIDE | EQ 0.0103% BASE | SOLUTION / INHALATION | AN | | 2013-12-13 |
| A078171-002 | LEVALBUTEROL HYDROCHLORIDE | LEVALBUTEROL HYDROCHLORIDE | EQ 0.021% BASE | SOLUTION / INHALATION | AN | | 2013-12-13 |
| A078171-003 | LEVALBUTEROL HYDROCHLORIDE | LEVALBUTEROL HYDROCHLORIDE | EQ 0.042% BASE | SOLUTION / INHALATION | AN | | 2013-12-13 |
Therapeutic equivalence codes#
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-410 | LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.31MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 0.63MG/3ML) SOLUTION LEVALBUTEROL INHALATION (LEVALBUTEROL INHALATION 1.25MG/3ML) SOLUTION [DR. REDDY’S LABORATORIES, INC.] | 4 | Legacy NDC | 20241222_163dfa7c-aad3-4290-9fe9-d9592b0ba317.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43598-410-25 | 43598041025 | 5 POUCH in 1 CARTON (43598-410-25) > 5 VIAL in 1 POUCH (43598-410-05) > 3 mL in 1 VIAL | 5 pouch | 2014-09-16 | 0000-00-00 | No | No | Current |