Terbutaline Sulfate
- Product NDC
- 53808-0312
- 11-digit product format
- 538080312
- Labeler code
- 53808
- Product ID
- 53808-0312_32eaf085-4c88-4aec-b763-9cfcc966ff5f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TERBUTALINE SULFATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- State of Florida DOH Central Pharmacy
- Application
- ANDA077152
- Marketing category
- ANDA
- Marketing start
- 2009-07-01
- Marketing end
- 0000-00-00
- Substance
- TERBUTALINE SULFATE
- Active strength
- 3 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 |
|---|---|---|---|---|---|
| 53808-0312-1 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c699-621f-e053-dbdaa90a74ad | TERBUTALINE Sulfate Tablets USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53808-0312-1 | Terbutaline Sulfate | 30 in 1 BLISTER PACK | TABLET | 30 | 1 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| 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 | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53808-0312 | TERBUTALINE SULFATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | Legacy NDC, 1 package rows | 20100611_352e3476-2bc4-4995-9fd9-4a8864417f1a.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 857677 | terbutaline sulfate 2.5 MG Oral Tablet | PSN | 352e3476-2bc4-4995-9fd9-4a8864417f1a | 1 |
| 857677 | terbutaline sulfate 2.5 MG Oral Tablet | SCD | 352e3476-2bc4-4995-9fd9-4a8864417f1a | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 53808-0312-1 | 53808031201 | 30 in 1 BLISTER PACK | Historical |