PROMETHEGAN
- Product NDC
- 55289-928
- 11-digit product format
- 552890928
- Labeler code
- 55289
- Product ID
- 55289-928_419b860e-68c0-f896-e063-6294a90aceb9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride
- Dosage form
- SUPPOSITORY
- Route
- RECTAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA040428
- Marketing category
- ANDA
- Marketing start
- 2002-02-28
- Substance
- PROMETHAZINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Phenothiazine [EPC], Phenothiazines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PROMETHEGAN
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PROMETHAZINE HYDROCHLORIDE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R61ZEH7I1I |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55289-928-02 | PROMETHEGAN | 2 in 1 BOTTLE, PLASTIC | SUPPOSITORY | 2 | | 14 |
| 55289-928-04 | PROMETHEGAN | 4 in 1 BOTTLE, PLASTIC | SUPPOSITORY | 4 | | 14 |
| 55289-928-06 | PROMETHEGAN | 6 in 1 BOTTLE, PLASTIC | SUPPOSITORY | 6 | | 14 |
| 55289-928-79 | PROMETHEGAN | 1 in 1 BOTTLE, PLASTIC | SUPPOSITORY | 1 | | 14 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Promethazine Hydrochloride | ACTIVE INGREDIENT | R61ZEH7I1I | PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.] | 1 | |
| Promethazine | ACTIVE MOIETY | FF28EJQ494 | PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.] | 1 | |
| Ascorbyl Palmitate | INACTIVE INGREDIENT | QN83US2B0N | PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.] | 1 | |
| Fat, Hard | INACTIVE INGREDIENT | 8334LX7S21 | PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.] | 1 | |
| Glyceryl Monostearate | INACTIVE INGREDIENT | 230OU9XXE4 | PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.] | 1 | |
| Silicon Dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.] | 1 | |
| White Wax | INACTIVE INGREDIENT | 7G1J5DA97F | PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55289-928 | PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.] | 13 | Current NDC, Legacy NDC, 4 package rows | 20240315_6b72dcf9-a4a1-4cc1-b7c2-a0bc2740fe97.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55289-928-02 | 55289092802 | 2 SUPPOSITORY in 1 BOTTLE, PLASTIC (55289-928-02) | 2 suppository | 2011-07-13 | 0000-00-00 | No | No | Current |
| 55289-928-04 | 55289092804 | 4 SUPPOSITORY in 1 BOTTLE, PLASTIC (55289-928-04) | 4 suppository | 2011-07-13 | 0000-00-00 | No | No | Current |
| 55289-928-06 | 55289092806 | 6 SUPPOSITORY in 1 BOTTLE, PLASTIC (55289-928-06) | 6 suppository | 2011-07-13 | 0000-00-00 | No | No | Current |
| 55289-928-79 | 55289092879 | 1 SUPPOSITORY in 1 BOTTLE, PLASTIC (55289-928-79) | 1 suppository | 2011-07-13 | 0000-00-00 | No | No | Current |