PROMETHAZINE HCI
- Product NDC
- 51662-1247
- 11-digit product format
- 516621247
- Labeler code
- 51662
- Product ID
- 51662-1247_12004c1b-f370-721b-e063-6294a90af6bb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PROMETHAZINE HCI
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- HF Acquisition Co. LLC, DBA HealthFirst
- Application
- ANDA083312
- Marketing category
- ANDA
- Marketing start
- 2018-08-26
- Substance
- PROMETHAZINE HYDROCHLORIDE
- Active strength
- 25 mg/mL
- 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
- PROMETHAZINE HCI
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PROMETHAZINE HYDROCHLORIDE | 25 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R61ZEH7I1I |
| Rxcui | 992460 |
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 |
|---|
| 51662-1247-1 | PROMETHAZINE HCI | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 1 | | 7 |
| 51662-1247-2 | PROMETHAZINE HCI | 1 mL in 1 POUCH | INJECTION | 1 | | 7 |
| 51662-1247-3 | PROMETHAZINE HCI | 25 in 1 CASE | INJECTION | 25 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51662-1247 | PROMETHAZINE HCI INJECTION [HF ACQUISITION CO. LLC, DBA HEALTHFIRST] | 7 | Current NDC, Legacy NDC, 3 package rows | 20240224_7447e8c6-c198-cd2d-e053-2a91aa0a3895.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 |
|---|
| 51662-1247-1 | 51662124701 | 1 mL in 1 VIAL, SINGLE-DOSE (51662-1247-1) | 1 ml | 2018-08-26 | 0000-00-00 | No | No | Current |
| 51662-1247-2 | 51662124702 | 1 mL in 1 POUCH | 1 ml | | | | | Historical |
| 51662-1247-3 | 51662124703 | 25 POUCH in 1 CASE (51662-1247-3) / 1 mL in 1 POUCH (51662-1247-2) | 25 pouch | 2020-10-27 | 0000-00-00 | No | No | Current |