Baclofen
- Product NDC
- 58517-440
- 11-digit product format
- 585170440
- Labeler code
- 58517
- Product ID
- 58517-440_165688ef-8ccc-47c2-ae3e-4c6bf2dcb048
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- New Horizon Rx Group, LLC
- Application
- ANDA077068
- Marketing category
- ANDA
- Marketing start
- 2013-08-25
- Marketing end
- 0000-00-00
- Substance
- BACLOFEN
- Active strength
- 10 mg/1
- Pharmacologic classes
- GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58517-440-30 | Baclofen | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| BACLOFEN | ACTIVE INGREDIENT | H789N3FKE8 | BACLOFEN TABLET [NEW HORIZON RX GROUP, LLC] | 1 | |
| BACLOFEN | ACTIVE MOIETY | H789N3FKE8 | BACLOFEN TABLET [NEW HORIZON RX GROUP, LLC] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | BACLOFEN TABLET [NEW HORIZON RX GROUP, LLC] | 1 | |
| CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE | INACTIVE INGREDIENT | O7TSZ97GEP | BACLOFEN TABLET [NEW HORIZON RX GROUP, LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | BACLOFEN TABLET [NEW HORIZON RX GROUP, LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | BACLOFEN TABLET [NEW HORIZON RX GROUP, LLC] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | BACLOFEN TABLET [NEW HORIZON RX GROUP, LLC] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | BACLOFEN TABLET [NEW HORIZON RX GROUP, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58517-440 | BACLOFEN TABLET [NEW HORIZON RX GROUP, LLC] | 1 | Legacy NDC, 1 package rows | 20131231_d6045fb8-9204-46cd-ab10-de8e9b1a41fe.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 58517-440-30 | 58517044030 | 30 in 1 BOTTLE | Historical |