Promethazine hydrochloride
- Product NDC
- 53808-0545
- 11-digit product format
- 538080545
- Labeler code
- 53808
- Product ID
- 53808-0545_b5cb6a82-f1ae-422a-909c-b75e214bbc40
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PROMETHAZINE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- State of Florida DOH Central Pharmacy
- Application
- ANDA040596
- Marketing category
- ANDA
- Marketing start
- 2009-07-01
- 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
- 2017-12-31
- 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 |
| 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 |
|---|---|---|---|---|---|
| 53808-0545-1 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-be98-621f-e053-dbdaa90a74ad | Promethazine Hydrochloride Tablets USP Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53808-0545-1 | Promethazine hydrochloride | 30 in 1 BLISTER PACK | TABLET | 30 | 1 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE | ACTIVE INGREDIENT | R61ZEH7I1I | PROMETHAZINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| PROMETHAZINE | ACTIVE MOIETY | FF28EJQ494 | PROMETHAZINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | INACTIVE INGREDIENT | L11K75P92J | PROMETHAZINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | PROMETHAZINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PROMETHAZINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | PROMETHAZINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | PROMETHAZINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53808-0545 | PROMETHAZINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | Legacy NDC, 1 package rows | 20100804_73a5ab08-ce67-44c4-8f1c-43131578fda8.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 992447 | promethazine HCl 25 MG Oral Tablet | PSN | 73a5ab08-ce67-44c4-8f1c-43131578fda8 | 1 |
| 992447 | promethazine hydrochloride 25 MG Oral Tablet | SCD | 73a5ab08-ce67-44c4-8f1c-43131578fda8 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 53808-0545-1 | 53808054501 | 30 in 1 BLISTER PACK | Historical |