Terbutaline Sulfate
- Product NDC
- 63323-665
- 11-digit product format
- 633230665
- Labeler code
- 63323
- Product ID
- 63323-665_15846c75-dc60-4339-b97b-5c9d78d66cf1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TERBUTALINE SULFATE
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA076887
- Marketing category
- ANDA
- Marketing start
- 2011-03-10
- Substance
- TERBUTALINE SULFATE
- Active strength
- 1 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Terbutaline Sulfate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TERBUTALINE SULFATE | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 576PU70Y8E |
| Rxcui | 857635 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-665-00 | Terbutaline Sulfate | 1 mL in 1 VIAL, SINGLE-USE | INJECTION, SOLUTION | 1 | | 4 |
| 63323-665-01 | Terbutaline Sulfate | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | | 4 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| TERBUTALINE SULFATE | ACTIVE INGREDIENT | 576PU70Y8E | TERBUTALINE SULFATE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 1 | |
| TERBUTALINE | ACTIVE MOIETY | N8ONU3L3PG | TERBUTALINE SULFATE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | TERBUTALINE SULFATE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | TERBUTALINE SULFATE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-665 | TERBUTALINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20220808_cec31032-f366-4524-9e01-63146e473b2b.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 |
|---|
| 63323-665-00 | 63323066500 | 1 mL in 1 VIAL, SINGLE-USE | 1 ml | | | | | Historical |
| 63323-665-01 | 63323066501 | 25 VIAL, SINGLE-USE in 1 TRAY (63323-665-01) / 1 mL in 1 VIAL, SINGLE-USE (63323-665-00) | | 2011-03-10 | 0000-00-00 | No | No | Current |