Rabeprazole Sodium
- Product NDC
- 71335-1558
- 11-digit product format
- 713351558
- Labeler code
- 71335
- Product ID
- 71335-1558_cd70a996-b785-4b4b-b0d5-868c7aaf323e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rabeprazole Sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA205761
- Marketing category
- ANDA
- Marketing start
- 2017-02-17
- Substance
- RABEPRAZOLE SODIUM
- Active strength
- 20 mg/1
- Pharmacologic classes
- Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 71335-1558_cd70a996-b785-4b4b-b0d5-868c7aaf323e
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Rabeprazole Sodium
- Generic name
- Rabeprazole Sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Marketing start
- 2017-02-17
- Marketing category
- ANDA
- Application number
- ANDA205761
- Pharmacologic classes
- Proton Pump Inhibitor [EPC]; Proton Pump Inhibitors [MoA]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| RABEPRAZOLE SODIUM | 20 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 3L36P16U4R |
| Rxcui | 854868 |
| Spl Set Id | b35f376a-f2a4-4eb9-80ac-9c20ceb2f0bf |
| Manufacturer Name | Bryant Ranch Prepack |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 3L36P16U4R | RABEPRAZOLE SODIUM | 117976-90-6 | RABEPRAZOLE SODIUM |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71335-1558-2 | 71335155802 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1558-2) | 2022-05-02 | 0000-00-00 | No | No | Current |
| 71335-1558-3 | 71335155803 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1558-3) | 2020-04-20 | 0000-00-00 | No | No | Current |
| 71335-1558-4 | 71335155804 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1558-4) | 2020-06-08 | 0000-00-00 | No | No | Current |
| 71335-1558-5 | 71335155805 | 28 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1558-5) | 2022-05-02 | 0000-00-00 | No | No | Current |
| 71335-1558-6 | 71335155806 | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1558-6) | 2022-05-02 | 0000-00-00 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Rabeprazole Sodium | Bryant Ranch Prepack | 2024-05-20 | HUMAN PRESCRIPTION DRUG LABEL | 4 |