PROMETHAZINE WITH CODEINE
- Product NDC
- 52959-118
- 11-digit product format
- 529590118
- Labeler code
- 52959
- Product ID
- 52959-118_73e55774-1468-b042-e053-2a91aa0aaffb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- H.J. Harkins Company,Inc.
- Application
- ANDA088875
- Marketing category
- ANDA
- Marketing start
- 2015-12-08
- Marketing end
- 0000-00-00
- Substance
- PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE
- Active strength
- 6 mg/5mL; mg/5mL
- Pharmacologic classes
- Phenothiazine [EPC],Phenothiazines [CS],Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CV
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 52959-118-04 | PROMETHAZINE WITH CODEINE | 118 mL in 1 BOTTLE, PLASTIC | SYRUP | 118 | | 1 |
| 52959-118-08 | PROMETHAZINE WITH CODEINE | 236 mL in 1 BOTTLE, PLASTIC | SYRUP | 236 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52959-118 | PROMETHAZINE WITH CODEINE (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [H.J. HARKINS COMPANY,INC.] | 1 | Legacy NDC, 2 package rows | 20180821_73828e5b-6a29-21d9-e053-2991aa0acac4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 52959-118-04 | 52959011804 | 118 mL in 1 BOTTLE, PLASTIC | 118 ml | Historical |
| 52959-118-08 | 52959011808 | 236 mL in 1 BOTTLE, PLASTIC | 236 ml | Historical |