COMPLERA
- Product NDC
- 61958-1101
- 11-digit product format
- 619581101
- Labeler code
- 61958
- Product ID
- 61958-1101_21d7850d-11ea-43cc-84a5-0dae02a19ce6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Gilead Sciences, Inc.
- Application
- NDA202123
- Marketing category
- NDA
- Marketing start
- 2011-08-10
- Substance
- EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE
- Active strength
- 200; 25; 300 mg/1; mg/1; mg/1
- Pharmacologic classes
- Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- COMPLERA
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| EMTRICITABINE | 200 mg/1 |
| RILPIVIRINE HYDROCHLORIDE | 25 mg/1 |
| TENOFOVIR DISOPROXIL FUMARATE | 300 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | G70B4ETF4S, 212WAX8KDD, OTT9J7900I |
| Rxcui | 1147334, 1147337 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61958-1101-1 | COMPLERA | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 21 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61958-1101-1 | EA - Each | 61958-1101 | 29146ed5-06b5-49ac-b942-66113b8f60ba | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61958-1101 | COMPLERA (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.] | 20 | Current NDC, Legacy NDC, 1 package rows | 20240927_d637cfab-f1e8-4eb3-a1b3-f85ca3bec612.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1147337 | COMPLERA 200 MG / 25 MG / 300 MG Oral Tablet | PSN | d637cfab-f1e8-4eb3-a1b3-f85ca3bec612 | 21 |
| 1147334 | emtricitabine 200 MG / rilpivirine HCl 25 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet | PSN | d637cfab-f1e8-4eb3-a1b3-f85ca3bec612 | 21 |
| 1147337 | emtricitabine 200 MG / rilpivirine 25 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet [Complera] | SBD | d637cfab-f1e8-4eb3-a1b3-f85ca3bec612 | 21 |
| 1147334 | emtricitabine 200 MG / rilpivirine 25 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet | SCD | d637cfab-f1e8-4eb3-a1b3-f85ca3bec612 | 21 |
| 1147337 | Complera (emtricitabine 200 MG / rilpivirine 25 MG (as rilpivirine hydrochloride 27.5 MG) / tenofovir disoproxil fumarate 300 MG (as tenofovir disoproxil 245 MG)) Oral Tablet | SY | d637cfab-f1e8-4eb3-a1b3-f85ca3bec612 | 21 |
| 1147337 | Complera (emtricitabine 200 MG / rilpivirine 25 MG / tenofovir disoproxil fumarate 300 MG) Oral Tablet | SY | d637cfab-f1e8-4eb3-a1b3-f85ca3bec612 | 21 |
| 1147334 | emtricitabine 200 MG / rilpivirine 25 MG (as rilpivirine hydrochloride 27.5 MG) / tenofovir disoproxil fumarate 300 MG (as tenofovir disoproxil 245 MG) Oral Tablet | SY | d637cfab-f1e8-4eb3-a1b3-f85ca3bec612 | 21 |
| 1147337 | COMPLERA 200 MG / 25 MG / 300 MG Oral Tablet | PSN | 54c8bec2-d565-489c-8d7c-afd3cdf78df5 | 1 |
| 1147334 | emtricitabine 200 MG / rilpivirine HCl 25 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet | PSN | 54c8bec2-d565-489c-8d7c-afd3cdf78df5 | 1 |
| 1147337 | emtricitabine 200 MG / rilpivirine 25 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet [Complera] | SBD | 54c8bec2-d565-489c-8d7c-afd3cdf78df5 | 1 |
| 1147334 | emtricitabine 200 MG / rilpivirine 25 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet | SCD | 54c8bec2-d565-489c-8d7c-afd3cdf78df5 | 1 |
| 1147337 | Complera (emtricitabine 200 MG / rilpivirine 25 MG (as rilpivirine hydrochloride 27.5 MG) / tenofovir disoproxil fumarate 300 MG (as tenofovir disoproxil 245 MG)) Oral Tablet | SY | 54c8bec2-d565-489c-8d7c-afd3cdf78df5 | 1 |
| 1147337 | Complera (emtricitabine 200 MG / rilpivirine 25 MG / tenofovir disoproxil fumarate 300 MG) Oral Tablet | SY | 54c8bec2-d565-489c-8d7c-afd3cdf78df5 | 1 |
| 1147334 | emtricitabine 200 MG / rilpivirine 25 MG (as rilpivirine hydrochloride 27.5 MG) / tenofovir disoproxil fumarate 300 MG (as tenofovir disoproxil 245 MG) Oral Tablet | SY | 54c8bec2-d565-489c-8d7c-afd3cdf78df5 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 61958-1101-1 | 61958110101 | 30 TABLET, FILM COATED in 1 BOTTLE (61958-1101-1) | 2011-08-10 | 0000-00-00 | No | No | Current |