PROMETHAZINE HYDROCHLORIDE
- Product NDC
- 61919-008
- 11-digit product format
- 619190008
- Labeler code
- 61919
- Product ID
- 61919-008_aa32bdf2-bae2-4d94-9365-b00c4fbee9ba
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PROMETHAZINE HYDROCHLORIDE tablet
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Direct Rx
- Application
- ANDA091179
- Marketing category
- ANDA
- Marketing start
- 2014-01-01
- 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 |
|---|---|---|---|---|---|
| 61919-008-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f70f-f424-e053-dadaa90a57ce | PROMETHAZINE HYDROCHLORIDE |
| 61919-008-12 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f70f-f424-e053-dadaa90a57ce | PROMETHAZINE HYDROCHLORIDE |
| 61919-008-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f70f-f424-e053-dadaa90a57ce | PROMETHAZINE HYDROCHLORIDE |
| 61919-008-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f70f-f424-e053-dadaa90a57ce | PROMETHAZINE HYDROCHLORIDE |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61919-008-10 | PROMETHAZINE HYDROCHLORIDE | 10 in 1 BOTTLE | TABLET | 10 | 3 | |
| 61919-008-12 | PROMETHAZINE HYDROCHLORIDE | 12 in 1 BOTTLE | TABLET | 12 | 3 | |
| 61919-008-30 | PROMETHAZINE HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET | 30 | 3 | |
| 61919-008-60 | PROMETHAZINE HYDROCHLORIDE | 60 in 1 BOTTLE | TABLET | 60 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61919-008-10 | EA - Each | 61919-008 | 84600f62-1e15-42e4-bc3d-66ed875481d1 | 1 | 2015-10-02 |
| 61919-008-12 | EA - Each | 61919-008 | 72afb94c-d5b8-46f6-b3c0-90bd003e8f15 | 1 | 2015-10-02 |
| 61919-008-30 | EA - Each | 61919-008 | 0feeca1a-44bf-4acb-a8d9-5428ca033cbd | 1 | 2015-10-02 |
| 61919-008-60 | EA - Each | 61919-008 | c1ee0514-3866-4638-9d92-710b8ec12c64 | 1 | 2019-09-05 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE | ACTIVE INGREDIENT | R61ZEH7I1I | PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE HYDROCHLORIDE TABLET) TABLET [DIRECT RX] | 3 | |
| PROMETHAZINE | ACTIVE MOIETY | FF28EJQ494 | PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE HYDROCHLORIDE TABLET) TABLET [DIRECT RX] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE HYDROCHLORIDE TABLET) TABLET [DIRECT RX] | 3 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE HYDROCHLORIDE TABLET) TABLET [DIRECT RX] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE HYDROCHLORIDE TABLET) TABLET [DIRECT RX] | 3 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 992447 | promethazine HCl 25 MG Oral Tablet | PSN | 51e3baab-eba7-460c-9de1-bf6cfc378310 | 3 |
| 992447 | promethazine hydrochloride 25 MG Oral Tablet | SCD | 51e3baab-eba7-460c-9de1-bf6cfc378310 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 61919-008-10 | 61919000810 | 10 in 1 BOTTLE | Historical |
| 61919-008-12 | 61919000812 | 12 in 1 BOTTLE | Historical |
| 61919-008-30 | 61919000830 | 30 in 1 BOTTLE | Historical |
| 61919-008-60 | 61919000860 | 60 in 1 BOTTLE | Historical |