Terbutaline Sulfate
- Product NDC
- 62559-722
- 11-digit product format
- 625590722
- Labeler code
- 62559
- Product ID
- 62559-722_ee722f8c-05d6-43bc-825d-9496579032c4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Terbutaline Sulfate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- NDA017849
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2018-10-16
- Substance
- TERBUTALINE SULFATE
- Active strength
- 5 mg/1
- 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 | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 576PU70Y8E |
| Rxcui | 857677, 857683 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62559-722-01 | Terbutaline Sulfate | 100 in 1 BOTTLE | TABLET | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62559-722 | TERBUTALINE SULFATE TABLET [ANI PHARMACEUTICALS, INC.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20191115_d810a15b-3e10-4f6c-a36e-8ddecbaba9c3.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 |
|---|
| 62559-722-01 | 62559072201 | 100 TABLET in 1 BOTTLE (62559-722-01) | 100 tablet | 2018-10-16 | 0000-00-00 | No | No | Current |