Terbutaline Sulfate
- Product NDC
- 21695-121
- 11-digit product format
- 216950121
- Labeler code
- 21695
- Product ID
- 21695-121_e53a8376-7107-473a-aa89-2cebee415864
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Terbutaline Sulfate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA077152
- Marketing category
- ANDA
- Marketing start
- 2005-03-25
- Marketing end
- 0000-00-00
- Substance
- TERBUTALINE SULFATE
- Active strength
- 5 mg/1
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 49ccb555-d142-0761-ee45-2e1304b37b1d | Product name | 2 | 20210111 |
| a3c04a67-87ea-e8b8-0458-db8085ac6340 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21695-121-00 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4830-48b1-e053-8cdaa90a720a | TERBUTALINE Sulfate Tablets USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-121-00 | Terbutaline Sulfate | 100 in 1 BOTTLE | TABLET | 100 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-121-00 | EA - Each | 21695-121 | 2b6a2f73-dcc9-4c99-b639-683e40f8808b | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Terbutaline Sulfate | ACTIVE INGREDIENT | 576PU70Y8E | TERBUTALINE SULFATE TABLET [REBEL DISTRIBUTORS CORP] | 2 | |
| Terbutaline | ACTIVE MOIETY | N8ONU3L3PG | TERBUTALINE SULFATE TABLET [REBEL DISTRIBUTORS CORP] | 2 | |
| anhydrous lactose | INACTIVE INGREDIENT | 3SY5LH9PMK | TERBUTALINE SULFATE TABLET [REBEL DISTRIBUTORS CORP] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TERBUTALINE SULFATE TABLET [REBEL DISTRIBUTORS CORP] | 2 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | TERBUTALINE SULFATE TABLET [REBEL DISTRIBUTORS CORP] | 2 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | TERBUTALINE SULFATE TABLET [REBEL DISTRIBUTORS CORP] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | TERBUTALINE SULFATE TABLET [REBEL DISTRIBUTORS CORP] | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 857677 | terbutaline sulfate 2.5 MG Oral Tablet | PSN | 879be756-991a-42c5-a381-9c8c2ad1fbdb | 2 |
| 857683 | terbutaline sulfate 5 MG Oral Tablet | PSN | 879be756-991a-42c5-a381-9c8c2ad1fbdb | 2 |
| 857677 | terbutaline sulfate 2.5 MG Oral Tablet | SCD | 879be756-991a-42c5-a381-9c8c2ad1fbdb | 2 |
| 857683 | terbutaline sulfate 5 MG Oral Tablet | SCD | 879be756-991a-42c5-a381-9c8c2ad1fbdb | 2 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 21695-121-00 | 21695012100 | 100 in 1 BOTTLE | Historical |