TERBUTALINE SULFATE
- Product NDC
- 0115-2611
- 11-digit product format
- 001152611
- Labeler code
- 0115
- Product ID
- 0115-2611_63142944-3083-4d47-908f-2984144b6c5d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TERBUTALINE SULFATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA075877
- Marketing category
- ANDA
- Marketing start
- 2001-06-26
- 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 |
|---|
| 0115-2611-01 | TERBUTALINE SULFATE | 100 in 1 BOTTLE | TABLET | 100 | | 13 |
| 0115-2611-02 | TERBUTALINE SULFATE | 500 in 1 BOTTLE | TABLET | 500 | | 13 |
| 0115-2611-03 | TERBUTALINE SULFATE | 1000 in 1 BOTTLE | TABLET | 1000 | | 13 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| TERBUTALINE SULFATE | ACTIVE INGREDIENT | 576PU70Y8E | TERBUTALINE SULFATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 2 | |
| TERBUTALINE | ACTIVE MOIETY | N8ONU3L3PG | TERBUTALINE SULFATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 2 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | TERBUTALINE SULFATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TERBUTALINE SULFATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 2 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | TERBUTALINE SULFATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TERBUTALINE SULFATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 2 | |
| POVIDONE K29/32 | INACTIVE INGREDIENT | 390RMW2PEQ | TERBUTALINE SULFATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | TERBUTALINE SULFATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0115-2611 | TERBUTALINE SULFATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 11 | Current NDC, Legacy NDC, 3 package rows | 20250108_382dcebb-6e41-4335-818d-b5822e3fb884.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 |
|---|
| 0115-2611-01 | 00115261101 | 100 TABLET in 1 BOTTLE (0115-2611-01) | 100 tablet | 2001-06-26 | 0000-00-00 | No | No | Current |
| 0115-2611-02 | 00115261102 | 500 TABLET in 1 BOTTLE (0115-2611-02) | 500 tablet | 2001-06-26 | 0000-00-00 | No | No | Current |
| 0115-2611-03 | 00115261103 | 1000 TABLET in 1 BOTTLE (0115-2611-03) | 1000 tablet | 2001-06-26 | 0000-00-00 | No | No | Current |