Promethazine
- Product NDC
- 54348-117
- 11-digit product format
- 543480117
- Labeler code
- 54348
- Product ID
- 54348-117_ea92baba-9184-5d68-e053-2a95a90a5e8f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PROMETHAZINE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PharmPak, Inc.
- Application
- ANDA040712
- Marketing category
- ANDA
- Marketing start
- 2019-07-11
- Substance
- PROMETHAZINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Phenothiazine [EPC], Phenothiazines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Promethazine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PROMETHAZINE HYDROCHLORIDE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R61ZEH7I1I |
| Rxcui | 992447 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54348-117 | PROMETHAZINE TABLET [PHARMPAK, INC.] | 2 | Current NDC, Legacy NDC, 20 package rows | 20221011_4f681538-7ac4-484c-9e6d-b571d73b9e0b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 54348-117-00 | 54348011700 | 1 BOTTLE in 1 BOX (54348-117-00) / 1 TABLET in 1 BOTTLE | 1 bottle | 2019-07-11 | 0000-00-00 | No | No | Current |
| 54348-117-02 | 54348011702 | 1 BOTTLE in 1 BOX (54348-117-02) / 2 TABLET in 1 BOTTLE | 1 bottle | 2019-07-11 | 0000-00-00 | No | No | Current |
| 54348-117-03 | 54348011703 | 1 BOTTLE in 1 BOX (54348-117-03) / 3 TABLET in 1 BOTTLE | 1 bottle | 2019-07-11 | 0000-00-00 | No | No | Current |
| 54348-117-04 | 54348011704 | 1 BOTTLE in 1 BOX (54348-117-04) / 4 TABLET in 1 BOTTLE | 1 bottle | 2019-07-11 | 0000-00-00 | No | No | Current |
| 54348-117-05 | 54348011705 | 1 BOTTLE in 1 BOX (54348-117-05) / 5 TABLET in 1 BOTTLE | 1 bottle | 2019-07-11 | 0000-00-00 | No | No | Current |
| 54348-117-06 | 54348011706 | 1 BOTTLE in 1 BOX (54348-117-06) / 6 TABLET in 1 BOTTLE | 1 bottle | 2019-07-11 | 0000-00-00 | No | No | Current |
| 54348-117-08 | 54348011708 | 1 BOTTLE in 1 BOX (54348-117-08) / 8 TABLET in 1 BOTTLE | 1 bottle | 2019-07-11 | 0000-00-00 | No | No | Current |
| 54348-117-09 | 54348011709 | 1 BOTTLE in 1 BOX (54348-117-09) / 9 TABLET in 1 BOTTLE | 1 bottle | 2019-07-11 | 0000-00-00 | No | No | Current |
| 54348-117-10 | 54348011710 | 1 BOTTLE in 1 BOX (54348-117-10) / 10 TABLET in 1 BOTTLE | 1 bottle | 2019-07-11 | 0000-00-00 | No | No | Current |
| 54348-117-12 | 54348011712 | 1 BOTTLE in 1 BOX (54348-117-12) / 12 TABLET in 1 BOTTLE | 1 bottle | 2019-07-11 | 0000-00-00 | No | No | Current |