Donnatal
- Product NDC
- 66689-063
- 11-digit product format
- 666890063
- Labeler code
- 66689
- Product ID
- 66689-063_b528eb39-f078-452f-939c-2daebd4d70ff
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide
- Dosage form
- ELIXIR
- Route
- ORAL
- Labeler
- VistaPharm, LLC
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2017-10-26
- Substance
- ATROPINE SULFATE; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE
- Active strength
- .0194; .1037; 16.2; .0065 mg/5mL; mg/5mL; mg/5mL; mg/5mL
- Pharmacologic classes
- Anticholinergic [EPC], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Donnatal
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ATROPINE SULFATE | .0194 mg/5mL |
| HYOSCYAMINE SULFATE | .1037 mg/5mL |
| PHENOBARBITAL | 16.2 mg/5mL |
| SCOPOLAMINE HYDROBROMIDE | .0065 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 03J5ZE7KA5, F2R8V82B84, YQE403BP4D, 451IFR0GXB |
| Rxcui | 1046787, 1046924 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 66689-063-10 | 2024-01-30 | C162847 | 48780-1 | 1030e364-f9ea-111a-e063-dadaa90a10e2 | DONNATAL® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) Elixir Rx Only |
| 66689-063-40 | 2024-01-30 | C162847 | 48780-1 | 1030e364-f9ea-111a-e063-dadaa90a10e2 | DONNATAL® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) Elixir Rx Only |
| 66689-063-50 | 2024-01-30 | C162847 | 48780-1 | 1030e364-f9ea-111a-e063-dadaa90a10e2 | DONNATAL® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) Elixir Rx Only |
| 66689-063-99 | 2024-01-30 | C162847 | 48780-1 | 1030e364-f9ea-111a-e063-dadaa90a10e2 | DONNATAL® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) Elixir Rx Only |
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 66689-063 | DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [VISTAPHARM, LLC] | 8 | Current NDC, Legacy NDC, 9 package rows | 20240209_11a48ba9-576b-4e8c-9536-6e83636d6930.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 |
|---|
| 66689-063-01 | 66689006301 | 5 mL in 1 CUP, UNIT-DOSE | 5 ml | | | | | Historical |
| 66689-063-10 | 66689006310 | 1 TRAY in 1 CASE (66689-063-10) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (66689-063-01) | 1 tray | 2017-10-26 | 0000-00-00 | No | No | Current |
| 66689-063-40 | 66689006340 | 4 TRAY in 1 CASE (66689-063-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (66689-063-01) | 4 tray | 2017-10-26 | 0000-00-00 | No | No | Current |
| 66689-063-50 | 66689006350 | 5 TRAY in 1 CASE (66689-063-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (66689-063-01) | 5 tray | 2017-10-26 | 0000-00-00 | No | No | Current |
| 66689-063-99 | 66689006399 | 10 TRAY in 1 CASE (66689-063-99) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (66689-063-01) | 10 tray | 2017-10-26 | 0000-00-00 | No | No | Current |