Hyoscyamine Sulfate
- Product NDC
- 53002-1135
- 11-digit product format
- 530021135
- Labeler code
- 53002
- Product ID
- 53002-1135_9d7f4f8e-16fe-479d-89d9-3ce781ed89b1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hyoscyamine Sulfate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2009-11-05
- Marketing end
- 0000-00-00
- Substance
- HYOSCYAMINE SULFATE
- Active strength
- 0 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 53002-1135-1 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-64ba-f424-e053-dadaa90a57ce | Hyoscyamine Sulfate Tablets, USP, 0.125 mg PI-9326 Rev 11/2017 Rx Only |
| 53002-1135-2 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-64ba-f424-e053-dadaa90a57ce | Hyoscyamine Sulfate Tablets, USP, 0.125 mg PI-9326 Rev 11/2017 Rx Only |
| 53002-1135-1 | 2020-12-15 | C162847 | 48780-1 | 9d75b9d0-64ba-f424-e053-dadaa90a57ce | Hyoscyamine Sulfate Tablets, USP, 0.125 mg PI-9326 Rev 11/2017 Rx Only |
| 53002-1135-2 | 2020-12-15 | C162847 | 48780-1 | 9d75b9d0-64ba-f424-e053-dadaa90a57ce | Hyoscyamine Sulfate Tablets, USP, 0.125 mg PI-9326 Rev 11/2017 Rx Only |
| 53002-1135-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-64ba-f424-e053-dadaa90a57ce | Hyoscyamine Sulfate Tablets, USP, 0.125 mg PI-9326 Rev 11/2017 Rx Only |
| 53002-1135-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-64ba-f424-e053-dadaa90a57ce | Hyoscyamine Sulfate Tablets, USP, 0.125 mg PI-9326 Rev 11/2017 Rx Only |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-1135-1 | Hyoscyamine Sulfate | 10 in 1 BOTTLE | TABLET | 10 | | 3 |
| 53002-1135-2 | Hyoscyamine Sulfate | 20 in 1 BOTTLE | TABLET | 20 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-1135 | HYOSCYAMINE SULFATE TABLET [RPK PHARMACEUTICALS, INC.] | 3 | Legacy NDC, 2 package rows | 20201217_04895e7e-0faa-4c4a-a1c1-203743608a3f.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 |
|---|
| 53002-1135-1 | 53002113501 | 10 TABLET in 1 BOTTLE (53002-1135-1) | 10 tablet | 2018-10-01 | 0000-00-00 | No | No | Current |
| 53002-1135-2 | 53002113502 | 20 TABLET in 1 BOTTLE (53002-1135-2) | 20 tablet | 2018-10-01 | 0000-00-00 | No | No | Current |