PHENADOZ
- Product NDC
- 0591-2985
- 11-digit product format
- 005912985
- Labeler code
- 0591
- Product ID
- 0591-2985_a37bad6a-a0cd-410c-a3cd-ee5706e11449
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride
- Dosage form
- SUPPOSITORY
- Route
- RECTAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA040428
- Marketing category
- ANDA
- Marketing start
- 2015-03-16
- Marketing end
- 2021-02-28
- Substance
- PROMETHAZINE HYDROCHLORIDE
- Active strength
- 13 mg/1
- Pharmacologic classes
- Phenothiazine [EPC],Phenothiazines [CS]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0591-2985-39 | EA - Each | 0591-2985 | a26c261f-a848-4592-af11-c2cd0d13aa00 | 1 | 2015-04-03 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 992443 | Phenadoz 12.5 MG Rectal Suppository | PSN | 5716b0d8-0efc-44aa-a17e-a51f24a0c8f1 | 4 |
| 992441 | promethazine HCl 12.5 MG Rectal Suppository | PSN | 5716b0d8-0efc-44aa-a17e-a51f24a0c8f1 | 4 |
| 992443 | promethazine hydrochloride 12.5 MG Rectal Suppository [Phenadoz] | SBD | 5716b0d8-0efc-44aa-a17e-a51f24a0c8f1 | 4 |
| 992441 | promethazine hydrochloride 12.5 MG Rectal Suppository | SCD | 5716b0d8-0efc-44aa-a17e-a51f24a0c8f1 | 4 |
| 992443 | Phenadoz 12.5 MG Rectal Suppository | SY | 5716b0d8-0efc-44aa-a17e-a51f24a0c8f1 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0591-2985-39 | 00591298539 | 12 PACKET in 1 BOX (0591-2985-39) > 1 SUPPOSITORY in 1 PACKET | 12 packet | 2015-03-16 | 2021-02-28 | No | No | Current |