zidovudine
- Product NDC
- 53104-0105
- 11-digit product format
- 531040105
- Labeler code
- 53104
- Product ID
- 53104-0105_e94ab1eb-51f3-4cb0-a4de-f3b93d3943b7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- zidovudine
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Cipla Ltd.
- Application
- ANDA077981
- Marketing category
- ANDA
- Marketing start
- 2008-06-26
- Marketing end
- 0000-00-00
- Substance
- ZIDOVUDINE
- Active strength
- 50 mg/5mL
- Pharmacologic classes
- Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fbdbfbef-2c33-0298-4fef-f6693e670fe1 | Product name | 7 | 20181210 |
| d07e0b9e-e041-41dc-942a-a2a6601dc221 | Product name | 1 | 20181029 |
| af19b329-4f44-cd81-491a-fbb7fe7a079f | Product name | 2 | 20151013 |
| e1098f43-eafb-82a0-ef30-575f1d8189b0 | Product name | 2 | 20150227 |
| 9ceb457b-0c09-9326-bbca-f296202d412c | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53104-0105-9 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-e894-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use Zidovudine safely and effectively. See full prescribing information for Zidovudine. ZIDOVUDINE Syrup [zidovudine oral solution] 50mg/5mL, for oral use Rx only Initial U.S. Approval: 1987 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53104-0105-9 | zidovudine | 240 mL in 1 BOTTLE | SYRUP | 240 | 18 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ZIDOVUDINE | ACTIVE INGREDIENT | 4B9XT59T7S | ZIDOVUDINE SYRUP [CIPLA LTD.] | 11 | |
| ZIDOVUDINE | ACTIVE MOIETY | 4B9XT59T7S | ZIDOVUDINE SYRUP [CIPLA LTD.] | 11 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | ZIDOVUDINE SYRUP [CIPLA LTD.] | 11 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | ZIDOVUDINE SYRUP [CIPLA LTD.] | 11 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | ZIDOVUDINE SYRUP [CIPLA LTD.] | 11 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | ZIDOVUDINE SYRUP [CIPLA LTD.] | 11 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53104-0105 | ZIDOVUDINE SYRUP [CIPLA LTD.] | 18 | Legacy NDC, 1 package rows | 20181218_e62ae0e4-0689-431a-a552-f0711ca68844.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 756209 | zidovudine 10 MG in 1 mL Oral Solution | PSN | e62ae0e4-0689-431a-a552-f0711ca68844 | 18 |
| 756209 | zidovudine 10 MG/ML Oral Solution | SCD | e62ae0e4-0689-431a-a552-f0711ca68844 | 18 |
| 756209 | AZT 10 MG/ML Oral Solution | SY | e62ae0e4-0689-431a-a552-f0711ca68844 | 18 |
| 756209 | zidovudine 10 MG per 1 ML Oral Solution | SY | e62ae0e4-0689-431a-a552-f0711ca68844 | 18 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 53104-0105-9 | 53104010509 | 240 mL in 1 BOTTLE | 240 ml | Historical |