Metoclopramide
- Product NDC
- 0121-0576
- 11-digit product format
- 001210576
- Labeler code
- 0121
- Product ID
- 0121-0576_9e77216c-c14e-4318-8569-288652321db9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- metoclopramide hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- PAI Holdings, LLC dba PAI Pharma
- Application
- ANDA072744
- Marketing category
- ANDA
- Marketing start
- 1991-06-01
- Substance
- METOCLOPRAMIDE HYDROCHLORIDE
- Active strength
- 5 mg/5mL
- Pharmacologic classes
- Dopamine D2 Antagonists [MoA], Dopamine-2 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Metoclopramide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METOCLOPRAMIDE HYDROCHLORIDE | 5 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | W1792A2RVD |
| Rxcui | 104884 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0121-0576-16 | Metoclopramide | 473 mL in 1 BOTTLE | SOLUTION | 473 | | 15 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Metoclopramide Hydrochloride | ACTIVE INGREDIENT | W1792A2RVD | METOCLOPRAMIDE (METOCLOPRAMIDE HYDROCHLORIDE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 9 | |
| Metoclopramide | ACTIVE MOIETY | L4YEB44I46 | METOCLOPRAMIDE (METOCLOPRAMIDE HYDROCHLORIDE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 9 | |
| citric acid monohydrate | INACTIVE INGREDIENT | 2968PHW8QP | METOCLOPRAMIDE (METOCLOPRAMIDE HYDROCHLORIDE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 9 | |
| FD&C Yellow No. 6 | INACTIVE INGREDIENT | H77VEI93A8 | METOCLOPRAMIDE (METOCLOPRAMIDE HYDROCHLORIDE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 9 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | METOCLOPRAMIDE (METOCLOPRAMIDE HYDROCHLORIDE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 9 | |
| methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | METOCLOPRAMIDE (METOCLOPRAMIDE HYDROCHLORIDE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 9 | |
| propylparaben | INACTIVE INGREDIENT | Z8IX2SC1OH | METOCLOPRAMIDE (METOCLOPRAMIDE HYDROCHLORIDE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 9 | |
| sorbitol | INACTIVE INGREDIENT | 506T60A25R | METOCLOPRAMIDE (METOCLOPRAMIDE HYDROCHLORIDE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 9 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | METOCLOPRAMIDE (METOCLOPRAMIDE HYDROCHLORIDE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 9 | |
| Metoclopramide Hydrochloride | ACTIVE INGREDIENT | W1792A2RVD | METOCLOPRAMIDE (METOCLOPRAMIDE HYDROCHLORIDE) SOLUTION [UNIT DOSE SERVICES] | 2 | |
| Metoclopramide | ACTIVE MOIETY | L4YEB44I46 | METOCLOPRAMIDE (METOCLOPRAMIDE HYDROCHLORIDE) SOLUTION [UNIT DOSE SERVICES] | 2 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | METOCLOPRAMIDE (METOCLOPRAMIDE HYDROCHLORIDE) SOLUTION [UNIT DOSE SERVICES] | 2 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | METOCLOPRAMIDE (METOCLOPRAMIDE HYDROCHLORIDE) SOLUTION [UNIT DOSE SERVICES] | 2 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | METOCLOPRAMIDE (METOCLOPRAMIDE HYDROCHLORIDE) SOLUTION [UNIT DOSE SERVICES] | 2 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | METOCLOPRAMIDE (METOCLOPRAMIDE HYDROCHLORIDE) SOLUTION [UNIT DOSE SERVICES] | 2 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | METOCLOPRAMIDE (METOCLOPRAMIDE HYDROCHLORIDE) SOLUTION [UNIT DOSE SERVICES] | 2 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | METOCLOPRAMIDE (METOCLOPRAMIDE HYDROCHLORIDE) SOLUTION [UNIT DOSE SERVICES] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | METOCLOPRAMIDE (METOCLOPRAMIDE HYDROCHLORIDE) SOLUTION [UNIT DOSE SERVICES] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0121-0576 | METOCLOPRAMIDE (METOCLOPRAMIDE HYDROCHLORIDE) SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA] | 15 | Current NDC, Legacy NDC, 1 package rows | 20241115_3cc8ca5b-8b71-4c77-a181-9ce154597b9a.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 |
|---|
| 0121-0576-16 | 00121057616 | 473 mL in 1 BOTTLE (0121-0576-16) | 473 ml | 1991-06-01 | 0000-00-00 | No | No | Current |