Promethazine Hydrochloride
- Product NDC
- 17856-0608
- 11-digit product format
- 178560608
- Labeler code
- 17856
- Product ID
- 17856-0608_3cebf14a-409b-495b-8a5f-4f3f0d7ec1c0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- ATLANTIC BIOLOGICALS CORP.
- Application
- ANDA087953
- Marketing category
- ANDA
- Marketing start
- 1982-11-15
- Marketing end
- 0000-00-00
- Substance
- PROMETHAZINE HYDROCHLORIDE
- Active strength
- 6 mg/5mL
- Pharmacologic classes
- Phenothiazine [EPC],Phenothiazines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 3036445d-7d13-4411-a100-f2ac5ab8a276 | Product name | 1 | 20240110 |
| 2e7222fb-e3f1-febd-962f-ddbb495d6b5f | Product name | 2 | 20220126 |
| 09d8330d-4fec-be98-3a66-f985140646b2 | Product name | 2 | 20210513 |
| c5cd4727-ac49-4409-82b1-5bd8006c3ec7 | Product name | 1 | 20171122 |
| 4f881de7-085a-407e-abc2-faa3c0127432 | Product name | 1 | 20170811 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
| d51697af-7f97-0559-95d1-fe94f3f031d5 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 17856-0608-5 | 2024-05-15 | C162847 | 48780-1 | 9d75b9d1-1b00-f424-e053-dadaa90a57ce | PROMETHAZINE SYRUP PLAIN 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP) |
| 17856-0608-5 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d1-1b00-f424-e053-dadaa90a57ce | PROMETHAZINE SYRUP PLAIN 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP) |
| 17856-0608-5 | 2021-09-02 | C162847 | 48780-1 | 9d75b9d1-1b00-f424-e053-dadaa90a57ce | PROMETHAZINE SYRUP PLAIN 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP) |
| 17856-0608-5 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-1b00-f424-e053-dadaa90a57ce | PROMETHAZINE SYRUP PLAIN 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 17856-0608-5 | Promethazine Hydrochloride | 5 mL in 1 CUP | SYRUP | 5 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 17856-0608-5 | ML - Milliliter | 17856-0608 | 5d4da32d-e749-4d01-91f6-cd9f1cf4ad4e | 1 | 2013-09-04 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 17856-0608 | PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORP.] | 5 | Legacy NDC, 1 package rows | 20240517_bbdbc61c-3923-4832-b0a5-c0365dd8f5f9.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 992432 | promethazine HCl 6.25 MG in 5 mL Oral Solution | PSN | bbdbc61c-3923-4832-b0a5-c0365dd8f5f9 | 5 |
| 992432 | promethazine hydrochloride 1.25 MG/ML Oral Solution | SCD | bbdbc61c-3923-4832-b0a5-c0365dd8f5f9 | 5 |
| 992432 | promethazine HCl 6.25 MG per 5 ML Oral Syrup | SY | bbdbc61c-3923-4832-b0a5-c0365dd8f5f9 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 17856-0608-5 | 17856060805 | 5 mL in 1 CUP (17856-0608-5) | 5 ml | 2021-09-02 | 0000-00-00 | No | No | Current |