Promethazine Hydrochloride
- Product NDC
- 0641-0928
- 11-digit product format
- 006410928
- Labeler code
- 0641
- Product ID
- 0641-0928_9f14d3f5-ad01-44b5-a2b7-16ed5f501f87
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA083312
- Marketing category
- ANDA
- Marketing start
- 1973-09-19
- 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 Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PROMETHAZINE HYDROCHLORIDE | 25 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | R61ZEH7I1I |
| Rxcui | 992460, 992858 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0641-0928-21 | Promethazine Hydrochloride | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 1 | 14 | |
| 0641-0928-25 | Promethazine Hydrochloride | 25 in 1 PACKAGE | INJECTION | 25 | 14 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0641-0928-21 | ML - Milliliter | 0641-0928 | 1b928e31-cfdb-4b72-bfe6-6784d16215a1 | 1 | 2012-07-24 |
| 0641-0928-25 | ML - Milliliter | 0641-0928 | ded9b273-d876-489b-82a8-0bc7c553c45c | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 992460 | promethazine HCl 25 MG in 1 ML Injection | PSN | 4bf3912c-8339-401e-9711-dad6acf15f11 | 14 |
| 992858 | promethazine HCl 50 MG in 1 ML Injection | PSN | 4bf3912c-8339-401e-9711-dad6acf15f11 | 14 |
| 992460 | 1 ML promethazine hydrochloride 25 MG/ML Injection | SCD | 4bf3912c-8339-401e-9711-dad6acf15f11 | 14 |
| 992858 | 1 ML promethazine hydrochloride 50 MG/ML Injection | SCD | 4bf3912c-8339-401e-9711-dad6acf15f11 | 14 |
| 992460 | promethazine HCl 25 MG per 1 ML Injection | SY | 4bf3912c-8339-401e-9711-dad6acf15f11 | 14 |
| 992858 | promethazine HCl 50 MG per 1 ML Injection | SY | 4bf3912c-8339-401e-9711-dad6acf15f11 | 14 |
| 992460 | promethazine HCl 25 MG in 1 ML Injection | PSN | 7ce351d8-47be-4937-aad2-153208c93b53 | 9 |
| 992460 | 1 ML promethazine hydrochloride 25 MG/ML Injection | SCD | 7ce351d8-47be-4937-aad2-153208c93b53 | 9 |
| 992460 | promethazine HCl 25 MG per 1 ML Injection | SY | 7ce351d8-47be-4937-aad2-153208c93b53 | 9 |
| 992460 | promethazine HCl 25 MG in 1 ML Injection | PSN | 7447e8c6-c198-cd2d-e053-2a91aa0a3895 | 7 |
| 992460 | 1 ML promethazine hydrochloride 25 MG/ML Injection | SCD | 7447e8c6-c198-cd2d-e053-2a91aa0a3895 | 7 |
| 992460 | promethazine HCl 25 MG per 1 ML Injection | SY | 7447e8c6-c198-cd2d-e053-2a91aa0a3895 | 7 |
| 992460 | promethazine HCl 25 MG in 1 ML Injection | PSN | 7fa840ad-10e7-4faf-9325-451648604161 | 6 |
| 992460 | 1 ML promethazine hydrochloride 25 MG/ML Injection | SCD | 7fa840ad-10e7-4faf-9325-451648604161 | 6 |
| 992460 | promethazine HCl 25 MG per 1 ML Injection | SY | 7fa840ad-10e7-4faf-9325-451648604161 | 6 |
| 992460 | promethazine HCl 25 MG in 1 ML Injection | PSN | 38673af1-112e-9ddd-e063-6294a90af465 | 3 |
| 992460 | promethazine HCl 25 MG in 1 ML Injection | PSN | 677b5fc5-94be-638b-e053-2991aa0a7f97 | 3 |
| 992460 | 1 ML promethazine hydrochloride 25 MG/ML Injection | SCD | 677b5fc5-94be-638b-e053-2991aa0a7f97 | 3 |
| 992460 | 1 ML promethazine hydrochloride 25 MG/ML Injection | SCD | 38673af1-112e-9ddd-e063-6294a90af465 | 3 |
| 992460 | promethazine HCl 25 MG per 1 ML Injection | SY | 677b5fc5-94be-638b-e053-2991aa0a7f97 | 3 |
| 992460 | promethazine HCl 25 MG per 1 ML Injection | SY | 38673af1-112e-9ddd-e063-6294a90af465 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0641-0928-21 | 00641092821 | 1 mL in 1 VIAL, SINGLE-DOSE | 1 ml | Historical | ||||
| 0641-0928-25 | 00641092825 | 25 VIAL, SINGLE-DOSE in 1 PACKAGE (0641-0928-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0641-0928-21) | 1973-09-19 | 0000-00-00 | No | No | Current |