PROMETHEGAN
- Product NDC
- 52959-731
- 11-digit product format
- 529590731
- Labeler code
- 52959
- Product ID
- 52959-731_a69a3507-3ae2-4226-86e6-3cc872ad2fdb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PROMETHAZINE HYDROCHLORIDE
- Dosage form
- SUPPOSITORY
- Route
- RECTAL
- Labeler
- H.J. Harkins Company, Inc.
- Application
- ANDA040428
- Marketing category
- ANDA
- Marketing start
- 2002-02-28
- Marketing end
- 0000-00-00
- Substance
- PROMETHAZINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Phenothiazine [EPC],Phenothiazines [CS]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 52959-731-10 | PROMETHEGAN | 1000 in 1 BOX | SUPPOSITORY | 1000 | | 2 |
| 52959-731-12 | PROMETHEGAN | 12 in 1 BOX | SUPPOSITORY | 12 | | 2 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Promethazine Hydrochloride | ACTIVE INGREDIENT | R61ZEH7I1I | PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [H.J. HARKINS COMPANY, INC.] | 2 | |
| Promethazine | ACTIVE MOIETY | FF28EJQ494 | PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [H.J. HARKINS COMPANY, INC.] | 2 | |
| Ascorbyl Palmitate | INACTIVE INGREDIENT | QN83US2B0N | PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [H.J. HARKINS COMPANY, INC.] | 2 | |
| Fat, Hard | INACTIVE INGREDIENT | 8334LX7S21 | PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [H.J. HARKINS COMPANY, INC.] | 2 | |
| Glyceryl Monostearate | INACTIVE INGREDIENT | 230OU9XXE4 | PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [H.J. HARKINS COMPANY, INC.] | 2 | |
| Silicon Dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [H.J. HARKINS COMPANY, INC.] | 2 | |
| White Wax | INACTIVE INGREDIENT | 7G1J5DA97F | PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [H.J. HARKINS COMPANY, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52959-731 | PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [H.J. HARKINS COMPANY, INC.] | 2 | Legacy NDC, 2 package rows | 20120312_80a7fabd-20c1-40fa-878e-7e62983dbc89.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 52959-731-10 | 52959073110 | 1000 in 1 BOX | Historical |
| 52959-731-12 | 52959073112 | 12 in 1 BOX | Historical |