Reglan
- Product NDC
- 62559-166
- 11-digit product format
- 625590166
- Labeler code
- 62559
- Product ID
- 62559-166_a7ad286f-c235-42bb-bc51-3f33a17e8dfe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metoclopramide Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- NDA017854
- Marketing category
- NDA
- Marketing start
- 2011-07-05
- Substance
- METOCLOPRAMIDE HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Dopamine D2 Antagonists [MoA], Dopamine-2 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Reglan
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METOCLOPRAMIDE HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | W1792A2RVD |
| Rxcui | 207265, 207266, 311666, 311668 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62559-166-01 | Reglan | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 8 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| METOCLOPRAMIDE HYDROCHLORIDE | ACTIVE INGREDIENT | W1792A2RVD | REGLAN (METOCLOPRAMIDE HYDROCHLORIDE) TABLET [ANI PHARMACEUTICALS, INC.] | 3 | |
| METOCLOPRAMIDE | ACTIVE MOIETY | L4YEB44I46 | REGLAN (METOCLOPRAMIDE HYDROCHLORIDE) TABLET [ANI PHARMACEUTICALS, INC.] | 3 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | REGLAN (METOCLOPRAMIDE HYDROCHLORIDE) TABLET [ANI PHARMACEUTICALS, INC.] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | REGLAN (METOCLOPRAMIDE HYDROCHLORIDE) TABLET [ANI PHARMACEUTICALS, INC.] | 3 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | REGLAN (METOCLOPRAMIDE HYDROCHLORIDE) TABLET [ANI PHARMACEUTICALS, INC.] | 3 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | REGLAN (METOCLOPRAMIDE HYDROCHLORIDE) TABLET [ANI PHARMACEUTICALS, INC.] | 3 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | REGLAN (METOCLOPRAMIDE HYDROCHLORIDE) TABLET [ANI PHARMACEUTICALS, INC.] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | REGLAN (METOCLOPRAMIDE HYDROCHLORIDE) TABLET [ANI PHARMACEUTICALS, INC.] | 3 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | REGLAN (METOCLOPRAMIDE HYDROCHLORIDE) TABLET [ANI PHARMACEUTICALS, INC.] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | REGLAN (METOCLOPRAMIDE HYDROCHLORIDE) TABLET [ANI PHARMACEUTICALS, INC.] | 3 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | REGLAN (METOCLOPRAMIDE HYDROCHLORIDE) TABLET [ANI PHARMACEUTICALS, INC.] | 3 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | REGLAN (METOCLOPRAMIDE HYDROCHLORIDE) TABLET [ANI PHARMACEUTICALS, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62559-166 | REGLAN (METOCLOPRAMIDE HYDROCHLORIDE) TABLET [ANI PHARMACEUTICALS, INC.] | 7 | Current NDC, Legacy NDC, 1 package rows | 20200618_de55c133-eb08-4a35-91a2-5dc093027397.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 |
|---|
| 62559-166-01 | 62559016601 | 100 TABLET in 1 BOTTLE, PLASTIC (62559-166-01) | 100 tablet | 2011-07-05 | 0000-00-00 | No | No | Current |