Baclofen
- Product NDC
- 0527-1330
- 11-digit product format
- 005271330
- Labeler code
- 0527
- Product ID
- 0527-1330_153f6bd7-9462-4d92-b738-48e7807c5919
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lannett Company, Inc.
- Application
- ANDA078220
- Marketing category
- ANDA
- Marketing start
- 2007-07-01
- 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
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Baclofen
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BACLOFEN | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | H789N3FKE8 |
| Rxcui | 197391, 197392, 430902 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0527-1330-01 | Baclofen | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 19 |
| 0527-1330-05 | Baclofen | 500 in 1 BOTTLE, PLASTIC | TABLET | 500 | | 19 |
| 0527-1330-10 | Baclofen | 1000 in 1 BOTTLE, PLASTIC | TABLET | 1000 | | 19 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| BACLOFEN | ACTIVE INGREDIENT | H789N3FKE8 | BACLOFEN TABLET [LANNETT COMPANY, INC.] | 9 | |
| BACLOFEN | ACTIVE MOIETY | H789N3FKE8 | BACLOFEN TABLET [LANNETT COMPANY, INC.] | 9 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | BACLOFEN TABLET [LANNETT COMPANY, INC.] | 9 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | BACLOFEN TABLET [LANNETT COMPANY, INC.] | 9 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | BACLOFEN TABLET [LANNETT COMPANY, INC.] | 9 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | BACLOFEN TABLET [LANNETT COMPANY, INC.] | 9 | |
| BACLOFEN | ACTIVE INGREDIENT | H789N3FKE8 | BACLOFEN TABLET [PROFICIENT RX LP] | 2 | |
| BACLOFEN | ACTIVE MOIETY | H789N3FKE8 | BACLOFEN TABLET [PROFICIENT RX LP] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | BACLOFEN TABLET [PROFICIENT RX LP] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | BACLOFEN TABLET [PROFICIENT RX LP] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | BACLOFEN TABLET [PROFICIENT RX LP] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | BACLOFEN TABLET [PROFICIENT RX LP] | 2 | |
| BACLOFEN | ACTIVE INGREDIENT | H789N3FKE8 | BACLOFEN TABLET [PREFERRED PHARMACEUTICALS, INC.] | 1 | |
| BACLOFEN | ACTIVE INGREDIENT | H789N3FKE8 | BACLOFEN TABLET [DIRECT RX] | 1 | |
| BACLOFEN | ACTIVE INGREDIENT | H789N3FKE8 | BACLOFEN TABLET [MAJOR PHARMACEUTICALS] | 1 | |
| BACLOFEN | ACTIVE MOIETY | H789N3FKE8 | BACLOFEN TABLET [MAJOR PHARMACEUTICALS] | 1 | |
| BACLOFEN | ACTIVE MOIETY | H789N3FKE8 | BACLOFEN TABLET [DIRECT RX] | 1 | |
| BACLOFEN | ACTIVE MOIETY | H789N3FKE8 | BACLOFEN TABLET [PREFERRED PHARMACEUTICALS, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | BACLOFEN TABLET [MAJOR PHARMACEUTICALS] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | BACLOFEN TABLET [DIRECT RX] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | BACLOFEN TABLET [PREFERRED PHARMACEUTICALS, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | BACLOFEN TABLET [DIRECT RX] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | BACLOFEN TABLET [MAJOR PHARMACEUTICALS] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | BACLOFEN TABLET [PREFERRED PHARMACEUTICALS, INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | BACLOFEN TABLET [MAJOR PHARMACEUTICALS] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | BACLOFEN TABLET [DIRECT RX] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | BACLOFEN TABLET [PREFERRED PHARMACEUTICALS, INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | BACLOFEN TABLET [MAJOR PHARMACEUTICALS] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | BACLOFEN TABLET [DIRECT RX] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | BACLOFEN TABLET [PREFERRED PHARMACEUTICALS, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0527-1330 | BACLOFEN TABLET [LANNETT COMPANY, INC.] | 19 | Current NDC, Legacy NDC, 3 package rows | 20210924_f84f3f4c-17e6-43f1-9600-63b0b175837b.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 |
|---|
| 0527-1330-01 | 00527133001 | 100 TABLET in 1 BOTTLE, PLASTIC (0527-1330-01) | 100 tablet | 2007-07-01 | 0000-00-00 | No | No | Current |
| 0527-1330-05 | 00527133005 | 500 TABLET in 1 BOTTLE, PLASTIC (0527-1330-05) | 500 tablet | 2007-07-01 | 0000-00-00 | No | No | Current |
| 0527-1330-10 | 00527133010 | 1000 TABLET in 1 BOTTLE, PLASTIC (0527-1330-10) | 1000 tablet | 2007-07-01 | 0000-00-00 | No | No | Current |