Hyoscyamine sulfate
- Product NDC
- 62135-858
- 11-digit product format
- 621350858
- Labeler code
- 62135
- Product ID
- 62135-858_22f63e6a-d1c4-1057-e063-6394a90a0721
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hyoscyamine sulfate
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2024-09-20
- Substance
- HYOSCYAMINE SULFATE
- Active strength
- .125 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
- Hyoscyamine sulfate
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| HYOSCYAMINE SULFATE | .125 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | F2R8V82B84 |
| Rxcui | 1046982, 1046985, 1047881, 1047895, 1047905 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 62135-858-12 | Hyoscyamine sulfate | 120 in 1 BOTTLE | TABLET, ORALLY DISINTEGRATING | 120 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 62135-858-12 | EA - Each | 62135-858 | 171bc05d-3342-4604-88d0-a3cee45c4f33 | 1 | 2024-10-04 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 62135-858 | HYOSCYAMINE SULFATE ELIXIR HYOSCYAMINE SULFATE SOLUTION HYOSCYAMINE SULFATE TABLET HYOSCYAMINE SULFATE TABLET, ORALLY DISINTEGRATING HYOSCYAMINE SULFATE SUBLINGUAL (HYOSCYAMINE SULFATE) TABLET [CHARTWELL RX, LLC] | 5 | Current NDC, 1 package rows | 20240927_526399a7-03ea-4d09-8dcd-d5cb012ab5c5.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1046985 | hyoscyamine sulfate 0.125 MG Disintegrating Oral Tablet | PSN | 526399a7-03ea-4d09-8dcd-d5cb012ab5c5 | 5 |
| 1047895 | hyoscyamine sulfate 0.125 MG in 1 mL Oral Solution | PSN | 526399a7-03ea-4d09-8dcd-d5cb012ab5c5 | 5 |
| 1047881 | hyoscyamine sulfate 0.125 MG in 5 mL Oral Solution | PSN | 526399a7-03ea-4d09-8dcd-d5cb012ab5c5 | 5 |
| 1047905 | hyoscyamine sulfate 0.125 MG Oral Tablet | PSN | 526399a7-03ea-4d09-8dcd-d5cb012ab5c5 | 5 |
| 1046982 | hyoscyamine sulfate 0.125 MG Sublingual Tablet | PSN | 526399a7-03ea-4d09-8dcd-d5cb012ab5c5 | 5 |
| 1047881 | hyoscyamine sulfate 0.025 MG/ML Oral Solution | SCD | 526399a7-03ea-4d09-8dcd-d5cb012ab5c5 | 5 |
| 1046985 | hyoscyamine sulfate 0.125 MG Disintegrating Oral Tablet | SCD | 526399a7-03ea-4d09-8dcd-d5cb012ab5c5 | 5 |
| 1047905 | hyoscyamine sulfate 0.125 MG Oral Tablet | SCD | 526399a7-03ea-4d09-8dcd-d5cb012ab5c5 | 5 |
| 1046982 | hyoscyamine sulfate 0.125 MG Sublingual Tablet | SCD | 526399a7-03ea-4d09-8dcd-d5cb012ab5c5 | 5 |
| 1047895 | hyoscyamine sulfate 0.125 MG/ML Oral Solution | SCD | 526399a7-03ea-4d09-8dcd-d5cb012ab5c5 | 5 |
| 1047895 | hyoscyamine sulfate 0.125 MG per 1 ML Oral Solution | SY | 526399a7-03ea-4d09-8dcd-d5cb012ab5c5 | 5 |
| 1047881 | hyoscyamine sulfate 0.125 MG per 5 ML Oral Solution | SY | 526399a7-03ea-4d09-8dcd-d5cb012ab5c5 | 5 |
| 1046982 | hyoscyamine sulfate SL 0.125 Disintegrating Sublingual Tablet | SY | 526399a7-03ea-4d09-8dcd-d5cb012ab5c5 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 62135-858-12 | 62135085812 | 120 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62135-858-12) | 2024-09-20 | No | No | Historical |