Baclofen
- Product NDC
- 52536-600
- 11-digit product format
- 525360600
- Labeler code
- 52536
- Product ID
- 52536-600_461e14b2-890c-011c-e063-6294a90a0d4c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- baclofen
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Wilshire Pharmaceuticals, Inc.
- Application
- NDA215602
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2023-04-01
- Substance
- BACLOFEN
- Active strength
- 5 mg/mL
- 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 | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | H789N3FKE8 |
| Rxcui | 2593376 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 52536-600-11 | Baclofen | 1 in 1 CARTON | SUSPENSION | 1 | | 3 |
| 52536-600-11 | Baclofen | 120 mL in 1 BOTTLE | SUSPENSION | 120 | | 3 |
| 52536-600-12 | Baclofen | 300 mL in 1 BOTTLE | SUSPENSION | 300 | | 3 |
| 52536-600-12 | Baclofen | 1 in 1 CARTON | SUSPENSION | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52536-600 | BACLOFEN SUSPENSION [WILSHIRE PHARMACEUTICALS, INC.] | 2 | Current NDC, 4 package rows | 20240518_4585aafe-0af8-4786-a419-6a7e76671ca2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 52536-600-11 | 52536060011 | 1 BOTTLE in 1 CARTON (52536-600-11) / 120 mL in 1 BOTTLE | 1 bottle | 2023-04-01 | No | No | Current |
| 52536-600-12 | 52536060012 | 1 BOTTLE in 1 CARTON (52536-600-12) / 300 mL in 1 BOTTLE | 1 bottle | 2023-04-01 | No | No | Current |