Hyosyne
- Product NDC
- 17856-0514
- 11-digit product format
- 178560514
- Labeler code
- 17856
- Product ID
- 17856-0514_34f474e7-be30-bf9e-e063-6294a90a9b9a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hyoscyamine Sulfate
- Dosage form
- ELIXIR
- Route
- ORAL
- Labeler
- ATLANTIC BIOLOGICALS CORP.
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 1997-11-01
- Substance
- HYOSCYAMINE SULFATE
- Active strength
- .125 mg/5mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hyosyne
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| HYOSCYAMINE SULFATE | .125 mg/5mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | F2R8V82B84 |
| Rxcui | 1047881 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 7792dadb-52b6-46b6-8fdf-80b1171065b5 | Product name | 1 | 20180810 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 6084a4f4-5437-c9a5-caec-5361ee075a59 | Product name | 1 | 20140508 |
| 90c5639a-61b0-88d6-ddcf-21888e94869a | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 17856-0514-5 | 2024-04-12 | C162847 | 48780-1 | 9d75b9d0-8e4b-f424-e053-dadaa90a57ce | HYOSYNE ORAL DROPS (Hyoscyamine Sulfate Oral Solution) HYOSYNE ELIXIR (Hyoscyamine Sulfate Elixir) |
| 17856-0514-5 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-8e4b-f424-e053-dadaa90a57ce | HYOSYNE ORAL DROPS (Hyoscyamine Sulfate Oral Solution) HYOSYNE ELIXIR (Hyoscyamine Sulfate Elixir) |
| 17856-0514-5 | 2021-06-17 | C162847 | 48780-1 | 9d75b9d0-8e4b-f424-e053-dadaa90a57ce | HYOSYNE ORAL DROPS (Hyoscyamine Sulfate Oral Solution) HYOSYNE ELIXIR (Hyoscyamine Sulfate Elixir) |
| 17856-0514-5 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-8e4b-f424-e053-dadaa90a57ce | HYOSYNE ORAL DROPS (Hyoscyamine Sulfate Oral Solution) HYOSYNE ELIXIR (Hyoscyamine Sulfate Elixir) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 17856-0514-5 | Hyosyne | 5 mL in 1 CUP | ELIXIR | 5 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 17856-0514 | HYOSYNE (HYOSCYAMINE SULFATE) ELIXIR [ATLANTIC BIOLOGICALS CORP.] | 5 | Current NDC, Legacy NDC, 1 package rows | 20250514_08ee0b24-a05b-451c-9d29-975570baed48.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1047881 | hyoscyamine sulfate 0.125 MG in 5 mL Oral Solution | PSN | 08ee0b24-a05b-451c-9d29-975570baed48 | 5 |
| 1047881 | hyoscyamine sulfate 0.025 MG/ML Oral Solution | SCD | 08ee0b24-a05b-451c-9d29-975570baed48 | 5 |
| 1047881 | hyoscyamine sulfate 0.125 MG per 5 ML Oral Solution | SY | 08ee0b24-a05b-451c-9d29-975570baed48 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 17856-0514-5 | 17856051405 | 5 mL in 1 CUP (17856-0514-5) | 5 ml | 2024-04-12 | 0000-00-00 | No | No | Current |