National Council for Prescription Drug Programs indexing - billing unit
- Manufacturer
- National Council for Prescription Drug Programs
- Effective date
- 2012-07-24
- Label type
- Indexing - Billing Unit
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-05 02:04:27
Label at a glance#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 54092-517-02 | EA - Each | 54092-517 | 765d54ae-93ba-410f-bc99-43098154bebf | 1 | 2012-07-24 |
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 54092-517 | 54092-517-02 |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022037-001 | INTUNIV | GUANFACINE HYDROCHLORIDE | EQ 1MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2009-09-02 |
| N022037-002 | INTUNIV | GUANFACINE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2009-09-02 |
| N022037-003 | INTUNIV | GUANFACINE HYDROCHLORIDE | EQ 3MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2009-09-02 |
| N022037-004 | INTUNIV | GUANFACINE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2009-09-02 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N022037-001 | AB |
| N022037-002 | AB |
| N022037-003 | AB |
| N022037-004 | AB |
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 | N022037-001 | INTUNIV | EQ 1MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2009-09-02 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N022037-002 | INTUNIV | EQ 2MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2009-09-02 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N022037-003 | INTUNIV | EQ 3MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2009-09-02 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N022037-004 | INTUNIV | EQ 4MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2009-09-02 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | N022037-001 | INTUNIV | EQ 1MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2009-09-02 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022037-002 | INTUNIV | EQ 2MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2009-09-02 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022037-003 | INTUNIV | EQ 3MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2009-09-02 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022037-004 | INTUNIV | EQ 4MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2009-09-02 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N022037-001 | INTUNIV | EQ 1MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2009-09-02 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022037-002 | INTUNIV | EQ 2MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2009-09-02 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022037-003 | INTUNIV | EQ 3MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2009-09-02 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022037-004 | INTUNIV | EQ 4MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2009-09-02 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N022037-001 | INTUNIV | EQ 1MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2009-09-02 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022037-002 | INTUNIV | EQ 2MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2009-09-02 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022037-003 | INTUNIV | EQ 3MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2009-09-02 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022037-004 | INTUNIV | EQ 4MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2009-09-02 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022037-001 | INTUNIV | EQ 1MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2009-09-02 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022037-002 | INTUNIV | EQ 2MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2009-09-02 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022037-003 | INTUNIV | EQ 3MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2009-09-02 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022037-004 | INTUNIV | EQ 4MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2009-09-02 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022037-001 | INTUNIV | EQ 1MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2009-09-02 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022037-002 | INTUNIV | EQ 2MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2009-09-02 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022037-003 | INTUNIV | EQ 3MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2009-09-02 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022037-004 | INTUNIV | EQ 4MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2009-09-02 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022037-001 | INTUNIV | EQ 1MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2009-09-02 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022037-002 | INTUNIV | EQ 2MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2009-09-02 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022037-003 | INTUNIV | EQ 3MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2009-09-02 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022037-004 | INTUNIV | EQ 4MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2009-09-02 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022037-001 | INTUNIV | EQ 1MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2009-09-02 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022037-002 | INTUNIV | EQ 2MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2009-09-02 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022037-003 | INTUNIV | EQ 3MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2009-09-02 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022037-004 | INTUNIV | EQ 4MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2009-09-02 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022037-001 | INTUNIV | EQ 1MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2009-09-02 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022037-002 | INTUNIV | EQ 2MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2009-09-02 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022037-003 | INTUNIV | EQ 3MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2009-09-02 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022037-004 | INTUNIV | EQ 4MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2009-09-02 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022037-001 | INTUNIV | EQ 1MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2009-09-02 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022037-002 | INTUNIV | EQ 2MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2009-09-02 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022037-003 | INTUNIV | EQ 3MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2009-09-02 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022037-004 | INTUNIV | EQ 4MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2009-09-02 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N022037-001 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N022037-002 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N022037-003 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N022037-004 | AB | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | N022037-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022037-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022037-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022037-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N022037-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022037-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022037-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022037-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N022037-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022037-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022037-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022037-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022037-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022037-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022037-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022037-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022037-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022037-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022037-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022037-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022037-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022037-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022037-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022037-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022037-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022037-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022037-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022037-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022037-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022037-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022037-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022037-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022037-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022037-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022037-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022037-004 | AB | 1 | 2680178bc6a6… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022037-001 | 6811794 | 2022-07-04 | U-494 | Drug product | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022037-001 | 6811794*PED | 2023-01-04 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022037-002 | 6811794 | 2022-07-04 | U-494 | Drug product | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022037-002 | 6811794*PED | 2023-01-04 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022037-003 | 6811794 | 2022-07-04 | U-494 | Drug product | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022037-003 | 6811794*PED | 2023-01-04 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022037-004 | 6811794 | 2022-07-04 | U-494 | Drug product | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022037-004 | 6811794*PED | 2023-01-04 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N022037-001 | 6811794 | 2022-07-04 | U-494 | Drug product | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022037-001 | 6811794*PED | 2023-01-04 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N022037-002 | 6811794 | 2022-07-04 | U-494 | Drug product | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022037-002 | 6811794*PED | 2023-01-04 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N022037-003 | 6811794 | 2022-07-04 | U-494 | Drug product | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022037-003 | 6811794*PED | 2023-01-04 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N022037-004 | 6811794 | 2022-07-04 | U-494 | Drug product | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022037-004 | 6811794*PED | 2023-01-04 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N022037-001 | 6811794 | 2022-07-04 | U-494 | Drug product | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N022037-001 | 6811794*PED | 2023-01-04 | Pediatric extension | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N022037-002 | 6811794 | 2022-07-04 | U-494 | Drug product | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N022037-002 | 6811794*PED | 2023-01-04 | Pediatric extension | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N022037-003 | 6811794 | 2022-07-04 | U-494 | Drug product | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N022037-003 | 6811794*PED | 2023-01-04 | Pediatric extension | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N022037-004 | 6811794 | 2022-07-04 | U-494 | Drug product | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N022037-004 | 6811794*PED | 2023-01-04 | Pediatric extension | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N022037-001 | 6287599 | 2020-12-20 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N022037-001 | 6287599*PED | 2021-06-20 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N022037-001 | 6811794 | 2022-07-04 | U-494 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N022037-001 | 6811794*PED | 2023-01-04 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N022037-002 | 6287599 | 2020-12-20 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N022037-002 | 6287599*PED | 2021-06-20 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N022037-002 | 6811794 | 2022-07-04 | U-494 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N022037-002 | 6811794*PED | 2023-01-04 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N022037-003 | 6287599 | 2020-12-20 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N022037-003 | 6287599*PED | 2021-06-20 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N022037-003 | 6811794 | 2022-07-04 | U-494 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N022037-003 | 6811794*PED | 2023-01-04 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N022037-004 | 6287599 | 2020-12-20 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N022037-004 | 6287599*PED | 2021-06-20 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N022037-004 | 6811794 | 2022-07-04 | U-494 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N022037-004 | 6811794*PED | 2023-01-04 | Pediatric extension | 74a2ff9319b5… |
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 |
|---|---|---|---|---|---|---|
| Intuniv | GUANFACINE | Takeda Pharmaceuticals America, Inc. | b972af81-3a37-40be-9fe1-3ddf59852528 | 2025-06-23 | Warnings, Adverse reactions | 54092-517-02 54092051702 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.