Terbutaline Sulfate
- Product NDC
- 0527-1318
- 11-digit product format
- 005271318
- Labeler code
- 0527
- Product ID
- 0527-1318_75d6b891-2c50-4748-829a-3567ee966978
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Terbutaline Sulfate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lannett Company, Inc.
- Application
- ANDA077152
- Marketing category
- ANDA
- Marketing start
- 2005-03-25
- Substance
- TERBUTALINE SULFATE
- Active strength
- 2.5 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 | 2.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 576PU70Y8E |
| Rxcui | 857677, 857683 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0527-1318-01 | Terbutaline Sulfate | 100 in 1 BOTTLE | TABLET | 100 | | 17 |
| 0527-1318-10 | Terbutaline Sulfate | 1000 in 1 BOTTLE | TABLET | 1000 | | 17 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| TERBUTALINE SULFATE | ACTIVE INGREDIENT | 576PU70Y8E | TERBUTALINE SULFATE TABLET [LANNETT COMPANY, INC.] | 11 | |
| TERBUTALINE | ACTIVE MOIETY | N8ONU3L3PG | TERBUTALINE SULFATE TABLET [LANNETT COMPANY, INC.] | 11 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | TERBUTALINE SULFATE TABLET [LANNETT COMPANY, INC.] | 11 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TERBUTALINE SULFATE TABLET [LANNETT COMPANY, INC.] | 11 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TERBUTALINE SULFATE TABLET [LANNETT COMPANY, INC.] | 11 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | TERBUTALINE SULFATE TABLET [LANNETT COMPANY, INC.] | 11 | |
| STARCH, PREGELATINIZED CORN | INACTIVE INGREDIENT | O8232NY3SJ | TERBUTALINE SULFATE TABLET [LANNETT COMPANY, INC.] | 11 | |
| TERBUTALINE SULFATE | ACTIVE INGREDIENT | 576PU70Y8E | TERBUTALINE SULFATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| TERBUTALINE | ACTIVE MOIETY | N8ONU3L3PG | TERBUTALINE SULFATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | TERBUTALINE SULFATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TERBUTALINE SULFATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TERBUTALINE SULFATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | TERBUTALINE SULFATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | TERBUTALINE SULFATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0527-1318 | TERBUTALINE SULFATE TABLET [LANNETT COMPANY, INC.] | 17 | Current NDC, Legacy NDC, 2 package rows | 20240704_fbf54709-5857-4dbc-9233-ebd7abff88c8.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 |
|---|
| 0527-1318-01 | 00527131801 | 100 TABLET in 1 BOTTLE (0527-1318-01) | 100 tablet | 2005-03-25 | 0000-00-00 | No | No | Current |
| 0527-1318-10 | 00527131810 | 1000 TABLET in 1 BOTTLE (0527-1318-10) | 1000 tablet | 2005-03-25 | 0000-00-00 | No | No | Current |