ISENTRESS
- Product NDC
- 0006-3603
- Requested package NDC
- 0006-3603-61
- 11-digit product format
- 000063603
- Labeler code
- 0006
- Product ID
- 0006-3603_71a854c7-afbd-4e62-9196-f37ec361e2a0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- RALTEGRAVIR
- Dosage form
- GRANULE, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Merck Sharp & Dohme LLC
- Application
- NDA205786
- Marketing category
- NDA
- Marketing start
- 2013-12-20
- Substance
- RALTEGRAVIR POTASSIUM
- Active strength
- 100 mg/1
- Pharmacologic classes
- HIV Integrase Inhibitors [MoA], Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N205786-001 | ISENTRESS | RALTEGRAVIR POTASSIUM | EQ 100MG BASE/PACKET | POWDER / ORAL | RLD, RS | 2013-12-20 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N205786-001 | 7754731 | 2029-03-11 | U-257 | Drug substance, Drug product | 2014-01-16 |
| N205786-001 | 7754731*PED | 2029-09-11 | Pediatric extension |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N205786-001 | ISENTRESS | EQ 100MG BASE/PACKET | POWDER / ORAL | RLD, RS | 2013-12-20 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N205786-001 | ISENTRESS | EQ 100MG BASE/PACKET | POWDER / ORAL | RLD, RS | 2013-12-20 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N205786-001 | ISENTRESS | EQ 100MG BASE/PACKET | POWDER / ORAL | RLD, RS | 2013-12-20 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205786-001 | ISENTRESS | EQ 100MG BASE/PACKET | POWDER / ORAL | RLD, RS | 2013-12-20 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205786-001 | ISENTRESS | EQ 100MG BASE/PACKET | POWDER / ORAL | RLD, RS | 2013-12-20 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205786-001 | ISENTRESS | EQ 100MG BASE/PACKET | POWDER / ORAL | RLD, RS | 2013-12-20 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205786-001 | ISENTRESS | EQ 100MG BASE/PACKET | POWDER / ORAL | RLD, RS | 2013-12-20 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205786-001 | ISENTRESS | EQ 100MG BASE/PACKET | POWDER / ORAL | RLD, RS | 2013-12-20 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N205786-001 | ISENTRESS | EQ 100MG BASE/PACKET | POWDER / ORAL | RLD, RS | 2013-12-20 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N205786-001 | ISENTRESS | EQ 100MG BASE/PACKET | POWDER / ORAL | RLD, RS | 2013-12-20 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N205786-001 | ISENTRESS | EQ 100MG BASE/PACKET | POWDER / ORAL | RLD, RS | 2013-12-20 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N205786-001 | ISENTRESS | EQ 100MG BASE/PACKET | POWDER / ORAL | RLD, RS | 2013-12-20 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N205786-001 | ISENTRESS | EQ 100MG BASE/PACKET | POWDER / ORAL | RLD, RS | 2013-12-20 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N205786-001 | ISENTRESS | EQ 100MG BASE/PACKET | POWDER / ORAL | RLD, RS | 2013-12-20 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N205786-001 | ISENTRESS | EQ 100MG BASE/PACKET | POWDER / ORAL | RLD, RS | 2013-12-20 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N205786-001 | ISENTRESS | EQ 100MG BASE/PACKET | POWDER / ORAL | RLD, RS | 2013-12-20 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N205786-001 | ISENTRESS | EQ 100MG BASE/PACKET | POWDER / ORAL | RLD, RS | 2013-12-20 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N205786-001 | ISENTRESS | EQ 100MG BASE/PACKET | POWDER / ORAL | RLD, RS | 2013-12-20 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N205786-001 | ISENTRESS | EQ 100MG BASE/PACKET | POWDER / ORAL | RLD, RS | 2013-12-20 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N205786-001 | ISENTRESS | EQ 100MG BASE/PACKET | POWDER / ORAL | RLD, RS | 2013-12-20 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N205786-001 | ISENTRESS | EQ 100MG BASE/PACKET | POWDER / ORAL | RLD, RS | 2013-12-20 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N205786-001 | ISENTRESS | EQ 100MG BASE/PACKET | POWDER / ORAL | RLD, RS | 2013-12-20 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N205786-001 | ISENTRESS | EQ 100MG BASE/PACKET | POWDER / ORAL | RLD, RS | 2013-12-20 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N205786-001 | ISENTRESS | EQ 100MG BASE/PACKET | POWDER / ORAL | RLD, RS | 2013-12-20 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N205786-001 | ISENTRESS | EQ 100MG BASE/PACKET | POWDER / ORAL | RLD, RS | 2013-12-20 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N205786-001 | ISENTRESS | EQ 100MG BASE/PACKET | POWDER / ORAL | RLD, RS | 2013-12-20 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N205786-001 | ISENTRESS | EQ 100MG BASE/PACKET | POWDER / ORAL | RLD, RS | 2013-12-20 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N205786-001 | ISENTRESS | EQ 100MG BASE/PACKET | POWDER / ORAL | RLD, RS | 2013-12-20 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N205786-001 | ISENTRESS | EQ 100MG BASE/PACKET | POWDER / ORAL | RLD, RS | 2013-12-20 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N205786-001 | ISENTRESS | EQ 100MG BASE/PACKET | POWDER / ORAL | RLD, RS | 2013-12-20 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N205786-001 | ISENTRESS | EQ 100MG BASE/PACKET | POWDER / ORAL | RLD, RS | 2013-12-20 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N205786-001 | ISENTRESS | EQ 100MG BASE/PACKET | POWDER / ORAL | RLD, RS | 2013-12-20 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N205786-001 | ISENTRESS | EQ 100MG BASE/PACKET | POWDER / ORAL | RLD, RS | 2013-12-20 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N205786-001 | ISENTRESS | EQ 100MG BASE/PACKET | POWDER / ORAL | RLD, RS | 2013-12-20 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N205786-001 | ISENTRESS | EQ 100MG BASE/PACKET | POWDER / ORAL | RLD, RS | 2013-12-20 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N205786-001 | ISENTRESS | EQ 100MG BASE/PACKET | POWDER / ORAL | RLD, RS | 2013-12-20 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N205786-001 | ISENTRESS | EQ 100MG BASE/PACKET | POWDER / ORAL | RLD, RS | 2013-12-20 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N205786-001 | ISENTRESS | EQ 100MG BASE/PACKET | POWDER / ORAL | RLD, RS | 2013-12-20 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N205786-001 | ISENTRESS | EQ 100MG BASE/PACKET | POWDER / ORAL | RLD, RS | 2013-12-20 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N205786-001 | ISENTRESS | EQ 100MG BASE/PACKET | POWDER / ORAL | RLD, RS | 2013-12-20 | 3a93d1ddd44b… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N205786-001 | 7754731 | 2029-03-11 | U-257 | Drug substance, Drug product | 2014-01-16 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N205786-001 | 7754731*PED | 2029-09-11 | Pediatric extension | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | N205786-001 | 7754731 | 2029-03-11 | U-257 | Drug substance, Drug product | 2014-01-16 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N205786-001 | 7754731*PED | 2029-09-11 | Pediatric extension | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N205786-001 | 7754731 | 2029-03-11 | U-257 | Drug substance, Drug product | 2014-01-16 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N205786-001 | 7754731*PED | 2029-09-11 | Pediatric extension | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N205786-001 | 7754731 | 2029-03-11 | U-257 | Drug substance, Drug product | 2014-01-16 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205786-001 | 7754731*PED | 2029-09-11 | Pediatric extension | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205786-001 | 7754731 | 2029-03-11 | U-257 | Drug substance, Drug product | 2014-01-16 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205786-001 | 7754731*PED | 2029-09-11 | Pediatric extension | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N205786-001 | 7754731 | 2029-03-11 | U-257 | Drug substance, Drug product | 2014-01-16 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N205786-001 | 7754731*PED | 2029-09-11 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205786-001 | 7754731 | 2029-03-11 | U-257 | Drug substance, Drug product | 2014-01-16 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205786-001 | 7754731*PED | 2029-09-11 | Pediatric extension | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205786-001 | 7754731 | 2029-03-11 | U-257 | Drug substance, Drug product | 2014-01-16 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205786-001 | 7754731*PED | 2029-09-11 | Pediatric extension | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N205786-001 | 7169780*PED | 2024-04-03 | Pediatric extension | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N205786-001 | 7754731 | 2029-03-11 | U-257 | Drug substance, Drug product | 2014-01-16 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N205786-001 | 7754731*PED | 2029-09-11 | Pediatric extension | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N205786-001 | 7169780*PED | 2024-04-03 | Pediatric extension | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N205786-001 | 7754731 | 2029-03-11 | U-257 | Drug substance, Drug product | 2014-01-16 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N205786-001 | 7754731*PED | 2029-09-11 | Pediatric extension | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N205786-001 | 7169780*PED | 2024-04-03 | Pediatric extension | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N205786-001 | 7754731 | 2029-03-11 | U-257 | Drug substance, Drug product | 2014-01-16 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N205786-001 | 7754731*PED | 2029-09-11 | Pediatric extension | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N205786-001 | 7169780*PED | 2024-04-03 | Pediatric extension | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N205786-001 | 7754731 | 2029-03-11 | U-257 | Drug substance, Drug product | 2014-01-16 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N205786-001 | 7754731*PED | 2029-09-11 | Pediatric extension | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N205786-001 | 7169780*PED | 2024-04-03 | Pediatric extension | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N205786-001 | 7754731 | 2029-03-11 | U-257 | Drug substance, Drug product | 2014-01-16 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N205786-001 | 7754731*PED | 2029-09-11 | Pediatric extension | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N205786-001 | 7169780*PED | 2024-04-03 | Pediatric extension | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N205786-001 | 7754731 | 2029-03-11 | U-257 | Drug substance, Drug product | 2014-01-16 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N205786-001 | 7754731*PED | 2029-09-11 | Pediatric extension | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N205786-001 | 7169780*PED | 2024-04-03 | Pediatric extension | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N205786-001 | 7754731 | 2029-03-11 | U-257 | Drug substance, Drug product | 2014-01-16 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N205786-001 | 7754731*PED | 2029-09-11 | Pediatric extension | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N205786-001 | 7169780*PED | 2024-04-03 | Pediatric extension | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N205786-001 | 7754731 | 2029-03-11 | U-257 | Drug substance, Drug product | 2014-01-16 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N205786-001 | 7754731*PED | 2029-09-11 | Pediatric extension | 1e350fbaab3a… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N205786-001 | NPP | 2020-11-22 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N205786-001 | PED | 2021-05-22 | 74a2ff9319b5… |
| 2021-12-28 21:50 UTC | 2021-12 | N205786-001 | PED | 2021-05-22 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N205786-001 | PED | 2021-05-22 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N205786-001 | PED | 2021-05-22 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N205786-001 | NPP | 2020-11-22 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N205786-001 | PED | 2021-05-22 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N205786-001 | NPP | 2020-11-22 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N205786-001 | PED | 2021-05-22 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N205786-001 | NPP | 2020-11-22 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N205786-001 | PED | 2021-05-22 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N205786-001 | NPP | 2020-11-22 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N205786-001 | PED | 2021-05-22 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N205786-001 | NPP | 2020-11-22 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N205786-001 | PED | 2021-05-22 | ea99ee380514… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ISENTRESS
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| RALTEGRAVIR POTASSIUM | 100 mg/1 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 323837e1-94ea-4944-ae44-aa6cc9ccda3b | Product name | 2 | 20260223 |
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| c873f14e-2add-4d53-b9b3-bf775efd3702 | Product name | 1 | 20150325 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0006-3603-01 | ISENTRESS | 1 in 1 PACKET | GRANULE, FOR SUSPENSION | 1 | 70 | |
| 0006-3603-60 | ISENTRESS | 60 in 1 CARTON | GRANULE, FOR SUSPENSION | 60 | 70 | |
| 0006-3603-61 | ISENTRESS | 60 in 1 CARTON | GRANULE, FOR SUSPENSION | 60 | 70 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0006-3603-01 | EA - Each | 0006-3603 | 2377cc21-50a6-4e45-b8f4-e530e7016b08 | 1 | 2015-12-02 |
| 0006-3603-60 | EA - Each | 0006-3603 | 3524abee-3ba7-4a61-9580-961e4bae0def | 1 | 2014-07-02 |
| 0006-3603-61 | EA - Each | 0006-3603 | d1737108-20d4-43b3-9a26-27412e79d68b | 1 | 2018-02-20 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0006-3603 | ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE ISENTRESS (RALTEGRAVIR) GRANULE, FOR SUSPENSION [MERCK SHARP & DOHME LLC] | 69 | Current NDC, Legacy NDC, 3 package rows | 20241030_89a5ec53-d956-4329-8004-0f40f51c88a3.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ISENTRESS | RALTEGRAVIR | Merck Sharp & Dohme LLC | 89a5ec53-d956-4329-8004-0f40f51c88a3 | 2024-10-18 | Warnings, Adverse reactions | 205786 NDA205786 0006-3603-61 0006-3603 00006360361 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1235591 | Isentress 100 MG Chewable Tablet | PSN | 89a5ec53-d956-4329-8004-0f40f51c88a3 | 70 |
| 1486841 | Isentress 100 MG Granules for Oral Suspension | PSN | 89a5ec53-d956-4329-8004-0f40f51c88a3 | 70 |
| 1235595 | Isentress 25 MG Chewable Tablet | PSN | 89a5ec53-d956-4329-8004-0f40f51c88a3 | 70 |
| 744846 | Isentress 400 MG Oral Tablet | PSN | 89a5ec53-d956-4329-8004-0f40f51c88a3 | 70 |
| 1924315 | Isentress 600 MG Oral Tablet | PSN | 89a5ec53-d956-4329-8004-0f40f51c88a3 | 70 |
| 1235588 | raltegravir 100 MG Chewable Tablet | PSN | 89a5ec53-d956-4329-8004-0f40f51c88a3 | 70 |
| 1486838 | raltegravir 100 MG Granules for Oral Suspension | PSN | 89a5ec53-d956-4329-8004-0f40f51c88a3 | 70 |
| 1235593 | raltegravir 25 MG Chewable Tablet | PSN | 89a5ec53-d956-4329-8004-0f40f51c88a3 | 70 |
| 744842 | raltegravir 400 MG Oral Tablet | PSN | 89a5ec53-d956-4329-8004-0f40f51c88a3 | 70 |
| 1924313 | raltegravir 600 MG Oral Tablet | PSN | 89a5ec53-d956-4329-8004-0f40f51c88a3 | 70 |
| 1235591 | raltegravir 100 MG Chewable Tablet [Isentress] | SBD | 89a5ec53-d956-4329-8004-0f40f51c88a3 | 70 |
| 1486841 | raltegravir 100 MG Granules for Oral Suspension [Isentress] | SBD | 89a5ec53-d956-4329-8004-0f40f51c88a3 | 70 |
| 1235595 | raltegravir 25 MG Chewable Tablet [Isentress] | SBD | 89a5ec53-d956-4329-8004-0f40f51c88a3 | 70 |
| 744846 | raltegravir 400 MG Oral Tablet [Isentress] | SBD | 89a5ec53-d956-4329-8004-0f40f51c88a3 | 70 |
| 1924315 | raltegravir 600 MG Oral Tablet [Isentress] | SBD | 89a5ec53-d956-4329-8004-0f40f51c88a3 | 70 |
| 1235588 | raltegravir 100 MG Chewable Tablet | SCD | 89a5ec53-d956-4329-8004-0f40f51c88a3 | 70 |
| 1486838 | raltegravir 100 MG Granules for Oral Suspension | SCD | 89a5ec53-d956-4329-8004-0f40f51c88a3 | 70 |
| 1235593 | raltegravir 25 MG Chewable Tablet | SCD | 89a5ec53-d956-4329-8004-0f40f51c88a3 | 70 |
| 744842 | raltegravir 400 MG Oral Tablet | SCD | 89a5ec53-d956-4329-8004-0f40f51c88a3 | 70 |
| 1924313 | raltegravir 600 MG Oral Tablet | SCD | 89a5ec53-d956-4329-8004-0f40f51c88a3 | 70 |
| 1486841 | Isentress (raltegravir 100 MG (as raltegravir potassium 108.8 MG)) Granules for Oral Suspension | SY | 89a5ec53-d956-4329-8004-0f40f51c88a3 | 70 |
| 1235591 | ISENTRESS 100 MG (raltegravir potassium 108.6 MG) Chewable Tablet | SY | 89a5ec53-d956-4329-8004-0f40f51c88a3 | 70 |
| 1235591 | ISENTRESS 100 MG Chewable Tablet | SY | 89a5ec53-d956-4329-8004-0f40f51c88a3 | 70 |
| 1486841 | Isentress 100 MG Granules for Oral Suspension | SY | 89a5ec53-d956-4329-8004-0f40f51c88a3 | 70 |
| 1235595 | ISENTRESS 25 MG (raltegravir potassium 27.16 MG) Chewable Tablet | SY | 89a5ec53-d956-4329-8004-0f40f51c88a3 | 70 |
| 1235595 | ISENTRESS 25 MG Chewable Tablet | SY | 89a5ec53-d956-4329-8004-0f40f51c88a3 | 70 |
| 744846 | ISENTRESS 400 MG (as raltegravir potassium 434.4 MG) Oral Tablet | SY | 89a5ec53-d956-4329-8004-0f40f51c88a3 | 70 |
| 744846 | ISENTRESS 400 MG Oral Tablet | SY | 89a5ec53-d956-4329-8004-0f40f51c88a3 | 70 |
| 1924315 | Isentress 600 MG (as raltegravir potassium 651.6 MG) Oral Tablet | SY | 89a5ec53-d956-4329-8004-0f40f51c88a3 | 70 |
| 1924315 | Isentress 600 MG Oral Tablet | SY | 89a5ec53-d956-4329-8004-0f40f51c88a3 | 70 |
| 1235588 | raltegravir (as raltegravir potassium) 100 MG Chewable Tablet | SY | 89a5ec53-d956-4329-8004-0f40f51c88a3 | 70 |
| 1235593 | raltegravir (as raltegravir potassium) 25 MG Chewable Tablet | SY | 89a5ec53-d956-4329-8004-0f40f51c88a3 | 70 |
| 1486838 | raltegravir 100 MG (as raltegravir potassium 108.8 MG) Granules for Oral Suspension | SY | 89a5ec53-d956-4329-8004-0f40f51c88a3 | 70 |
| 744842 | raltegravir 400 MG (as raltegravir potassium 434.4 MG) Oral Tablet | SY | 89a5ec53-d956-4329-8004-0f40f51c88a3 | 70 |
| 1924313 | raltegravir 600 MG (as raltegravir potassium 651.6 MG) Oral Tablet | SY | 89a5ec53-d956-4329-8004-0f40f51c88a3 | 70 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0006-3603-61 | 00006360361 | 60 PACKET in 1 CARTON (0006-3603-61) / 1 GRANULE, FOR SUSPENSION in 1 PACKET (0006-3603-01) | 60 packet | 2017-11-22 | 0000-00-00 | No | No | Current |