Inderal XL
- Product NDC
- 62559-601
- 11-digit product format
- 625590601
- Labeler code
- 62559
- Product ID
- 62559-601_2b2778d4-efb2-4541-8264-375ad6082cb6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- propranolol hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- NDA021438
- Marketing category
- NDA
- Marketing start
- 2018-02-22
- Substance
- PROPRANOLOL HYDROCHLORIDE
- Active strength
- 120 mg/1
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Inderal XL
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PROPRANOLOL HYDROCHLORIDE | 120 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | F8A3652H1V |
| Rxcui | 856460, 856462, 856569, 856571 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62559-601-14 | Inderal XL | 14 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 14 | | 8 |
| 62559-601-30 | Inderal XL | 30 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 30 | | 8 |
| 62559-601-77 | Inderal XL | 7 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 7 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62559-601 | INDERAL XL (PROPRANOLOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.] | 8 | Current NDC, Legacy NDC, 3 package rows | 20240322_ac196ff5-9215-402b-bc57-69aa87f8bade.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 62559-601-14 | 62559060114 | 14 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-601-14) | 2021-09-01 | 0000-00-00 | No | No | Current |
| 62559-601-30 | 62559060130 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-601-30) | 2018-02-22 | 0000-00-00 | No | No | Current |
| 62559-601-77 | 62559060177 | 7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-601-77) | 2018-02-22 | 0000-00-00 | No | No | Current |