LAMIVUDINE and ZIDOVUDINE
- Product NDC
- 43063-900
- 11-digit product format
- 430630900
- Labeler code
- 43063
- Product ID
- 43063-900_415d1735-9f33-0e91-e063-6394a90a16de
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LAMIVUDINE and ZIDOVUDINE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA079124
- Marketing category
- ANDA
- Marketing start
- 2015-09-18
- Substance
- LAMIVUDINE; ZIDOVUDINE
- Active strength
- 150; 300 mg/1; mg/1
- Pharmacologic classes
- Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- LAMIVUDINE and ZIDOVUDINE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LAMIVUDINE | 150 mg/1 |
| ZIDOVUDINE | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2T8Q726O95, 4B9XT59T7S |
| Rxcui | 200082 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43063-900-06 | LAMIVUDINE and ZIDOVUDINE | 6 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 6 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-900 | LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 12 | Current NDC, Legacy NDC, 1 package rows | 20241018_ff62c5fc-965d-4534-a571-a4f290cb9d83.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43063-900-06 | 43063090006 | 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-900-06) | 2018-10-11 | 0000-00-00 | No | No | Current |