Rabeprazole Sodium
- Product NDC
- 65162-724
- 11-digit product format
- 651620724
- Labeler code
- 65162
- Product ID
- 65162-724_f02b0373-dbac-4842-bf97-3352b8c74089
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rabeprazole
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA204179
- Marketing category
- ANDA
- Marketing start
- 2015-10-01
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Rabeprazole Sodium
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| RABEPRAZOLE SODIUM | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3L36P16U4R |
| Rxcui | 854868 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65162-724-03 | Rabeprazole Sodium | 30 in 1 BOTTLE | TABLET, DELAYED RELEASE | 30 | | 24 |
| 65162-724-09 | Rabeprazole Sodium | 90 in 1 BOTTLE | TABLET, DELAYED RELEASE | 90 | | 24 |
| 65162-724-11 | Rabeprazole Sodium | 1000 in 1 BOTTLE | TABLET, DELAYED RELEASE | 1000 | | 24 |
| 65162-724-50 | Rabeprazole Sodium | 500 in 1 BOTTLE | TABLET, DELAYED RELEASE | 500 | | 24 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| RABEPRAZOLE SODIUM | ACTIVE INGREDIENT | 3L36P16U4R | RABEPRAZOLE SODIUM (RABEPRAZOLE) TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
| RABEPRAZOLE | ACTIVE MOIETY | 32828355LL | RABEPRAZOLE SODIUM (RABEPRAZOLE) TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | RABEPRAZOLE SODIUM (RABEPRAZOLE) TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
| CROSPOVIDONE (12 MPA.S AT 5%) | INACTIVE INGREDIENT | 40UAA97IT9 | RABEPRAZOLE SODIUM (RABEPRAZOLE) TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
| DIETHYL PHTHALATE | INACTIVE INGREDIENT | UF064M00AF | RABEPRAZOLE SODIUM (RABEPRAZOLE) TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
| ETHYLCELLULOSES | INACTIVE INGREDIENT | 7Z8S9VYZ4B | RABEPRAZOLE SODIUM (RABEPRAZOLE) TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | RABEPRAZOLE SODIUM (RABEPRAZOLE) TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | RABEPRAZOLE SODIUM (RABEPRAZOLE) TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
| HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED | INACTIVE INGREDIENT | 2165RE0K14 | RABEPRAZOLE SODIUM (RABEPRAZOLE) TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
| HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST) | INACTIVE INGREDIENT | 87Y6436BKR | RABEPRAZOLE SODIUM (RABEPRAZOLE) TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
| MAGNESIUM OXIDE | INACTIVE INGREDIENT | 3A3U0GI71G | RABEPRAZOLE SODIUM (RABEPRAZOLE) TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | RABEPRAZOLE SODIUM (RABEPRAZOLE) TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | RABEPRAZOLE SODIUM (RABEPRAZOLE) TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | RABEPRAZOLE SODIUM (RABEPRAZOLE) TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | RABEPRAZOLE SODIUM (RABEPRAZOLE) TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
| SODIUM STEARYL FUMARATE | INACTIVE INGREDIENT | 7CV7WJK4UI | RABEPRAZOLE SODIUM (RABEPRAZOLE) TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | RABEPRAZOLE SODIUM (RABEPRAZOLE) TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | RABEPRAZOLE SODIUM (RABEPRAZOLE) TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-724 | RABEPRAZOLE SODIUM (RABEPRAZOLE) TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS LLC] | 24 | Current NDC, Legacy NDC, 4 package rows | 20241031_951caefe-6e18-48ff-9567-beb545b09c25.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 |
|---|
| 65162-724-03 | 65162072403 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-724-03) | 2015-10-01 | 0000-00-00 | No | No | Current |
| 65162-724-09 | 65162072409 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-724-09) | 2015-10-01 | 0000-00-00 | No | No | Current |
| 65162-724-11 | 65162072411 | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-724-11) | 2015-10-01 | 0000-00-00 | No | No | Current |
| 65162-724-50 | 65162072450 | 500 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-724-50) | 2015-10-01 | 0000-00-00 | No | No | Current |