Promethazine Hydrochloride
- Product NDC
- 0781-1830
- 11-digit product format
- 007811830
- Labeler code
- 0781
- Product ID
- 0781-1830_6917d220-8289-4719-bfee-f6e6d201ed12
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Sandoz Inc
- Application
- ANDA084176
- Marketing category
- ANDA
- Marketing start
- 1975-12-19
- Marketing end
- 0000-00-00
- Substance
- PROMETHAZINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Phenothiazine [EPC],Phenothiazines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 |
|---|---|---|---|---|---|
| 0781-1830-01 | 2020-08-18 | C162847 | 48780-1 | ab0e2407-297d-f274-e053-dbdaa90a6471 | 24086b53-a85c-443e-ad85-c1295ddf23c7 |
| 0781-1830-10 | 2020-08-18 | C162847 | 48780-1 | ab0e2407-297d-f274-e053-dbdaa90a6471 | 24086b53-a85c-443e-ad85-c1295ddf23c7 |
| 0781-1830-01 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-297d-f274-e053-dbdaa90a6471 | 24086b53-a85c-443e-ad85-c1295ddf23c7 |
| 0781-1830-10 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-297d-f274-e053-dbdaa90a6471 | 24086b53-a85c-443e-ad85-c1295ddf23c7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0781-1830-01 | EA - Each | 0781-1830 | c3b3f3ae-5146-4e1a-89d0-e91c9d709e4b | 1 | 2012-07-24 |
| 0781-1830-10 | EA - Each | 0781-1830 | 4fb50921-d449-43b0-b75f-eb03c4817ca1 | 1 | 2012-07-24 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 992447 | promethazine HCl 25 MG Oral Tablet | PSN | d253fa90-bacd-4029-9a51-8863fa0b687b | 5 |
| 992447 | promethazine hydrochloride 25 MG Oral Tablet | SCD | d253fa90-bacd-4029-9a51-8863fa0b687b | 5 |
| 992447 | promethazine HCl 25 MG Oral Tablet | PSN | eb98fd48-d696-4038-8de6-9e9b3fcfc9dc | 4 |
| 992447 | promethazine hydrochloride 25 MG Oral Tablet | SCD | eb98fd48-d696-4038-8de6-9e9b3fcfc9dc | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0781-1830-01 | 00781183001 | 100 TABLET in 1 BOTTLE (0781-1830-01) | 100 tablet | 1975-12-19 | 0000-00-00 | No | No | Current |
| 0781-1830-10 | 00781183010 | 1000 TABLET in 1 BOTTLE (0781-1830-10) | 1000 tablet | 1975-12-19 | 0000-00-00 | No | No | Current |