Premarin
- Product NDC
- 0046-0749
- 11-digit product format
- 000460749
- Labeler code
- 0046
- Product ID
- 0046-0749_97a59d56-720c-42fd-86b7-00ad93752452
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CONJUGATED ESTROGENS
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
- Application
- NDA010402
- Marketing category
- NDA
- Marketing start
- 1956-12-01
- Substance
- ESTROGENS, CONJUGATED
- Active strength
- 25 mg/5mL
- Pharmacologic classes
- Estrogen Receptor Agonists [MoA], Estrogen [EPC], Estrogens, Conjugated (USP) [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Premarin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ESTROGENS, CONJUGATED | 25 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | IU5QR144QX |
| Rxcui | 211975, 310203 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0046-0749-05 | Premarin | 5 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 5 | | 22 |
| 0046-0749-05 | Premarin | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 22 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ESTROGENS, CONJUGATED | ACTIVE INGREDIENT | IU5QR144QX | PREMARIN (CONJUGATED ESTROGENS) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 12 | |
| ESTROGENS, CONJUGATED | ACTIVE MOIETY | IU5QR144QX | PREMARIN (CONJUGATED ESTROGENS) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 12 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | PREMARIN (CONJUGATED ESTROGENS) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 12 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | PREMARIN (CONJUGATED ESTROGENS) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 12 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0046-0749 | PREMARIN (CONJUGATED ESTROGENS) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.] | 21 | Current NDC, Legacy NDC, 2 package rows | 20240308_87e2da8d-432c-4ed5-67a1-dc26294b2295.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 |
|---|
| 0046-0749-05 | 00046074905 | 1 VIAL in 1 CARTON (0046-0749-05) / 5 mL in 1 VIAL | 1 vial | 1956-12-01 | 0000-00-00 | No | No | Current |