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 01:12:54
Label at a glance#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0555-0787-02 | EA - Each | 0555-0787 | 151f9e9d-f73d-460e-af94-e29ae493cc8a | 1 | 2012-07-24 |
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0555-0787 | 0555-0787-02 |
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 |
|---|---|---|---|---|---|---|---|
| N021303-001 | ADDERALL XR 10 | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 2.5MG;2.5MG;2.5MG;2.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2001-10-11 |
| N021303-002 | ADDERALL XR 20 | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 5MG;5MG;5MG;5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2001-10-11 |
| N021303-003 | ADDERALL XR 30 | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 7.5MG;7.5MG;7.5MG;7.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD, RS | 2001-10-11 |
| N021303-004 | ADDERALL XR 25 | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-05-22 |
| N021303-005 | ADDERALL XR 5 | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 1.25MG;1.25MG;1.25MG;1.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-05-22 |
| N021303-006 | ADDERALL XR 15 | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 3.75MG;3.75MG;3.75MG;3.75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-05-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021303-001 | AB1 |
| N021303-002 | AB1 |
| N021303-003 | AB1 |
| N021303-004 | AB1 |
| N021303-005 | AB1 |
| N021303-006 | AB1 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N021303-001 | ADDERALL XR 10 | 2.5MG;2.5MG;2.5MG;2.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2001-10-11 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021303-002 | ADDERALL XR 20 | 5MG;5MG;5MG;5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2001-10-11 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021303-003 | ADDERALL XR 30 | 7.5MG;7.5MG;7.5MG;7.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD, RS | 2001-10-11 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021303-004 | ADDERALL XR 25 | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-05-22 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021303-005 | ADDERALL XR 5 | 1.25MG;1.25MG;1.25MG;1.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-05-22 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021303-006 | ADDERALL XR 15 | 3.75MG;3.75MG;3.75MG;3.75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-05-22 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N021303-001 | ADDERALL XR 10 | 2.5MG;2.5MG;2.5MG;2.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2001-10-11 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021303-002 | ADDERALL XR 20 | 5MG;5MG;5MG;5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2001-10-11 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021303-003 | ADDERALL XR 30 | 7.5MG;7.5MG;7.5MG;7.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD, RS | 2001-10-11 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021303-004 | ADDERALL XR 25 | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-05-22 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021303-005 | ADDERALL XR 5 | 1.25MG;1.25MG;1.25MG;1.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-05-22 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021303-006 | ADDERALL XR 15 | 3.75MG;3.75MG;3.75MG;3.75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-05-22 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N021303-001 | ADDERALL XR 10 | 2.5MG;2.5MG;2.5MG;2.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2001-10-11 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021303-002 | ADDERALL XR 20 | 5MG;5MG;5MG;5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2001-10-11 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021303-003 | ADDERALL XR 30 | 7.5MG;7.5MG;7.5MG;7.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD, RS | 2001-10-11 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021303-004 | ADDERALL XR 25 | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-05-22 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021303-005 | ADDERALL XR 5 | 1.25MG;1.25MG;1.25MG;1.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-05-22 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021303-006 | ADDERALL XR 15 | 3.75MG;3.75MG;3.75MG;3.75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-05-22 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021303-001 | ADDERALL XR 10 | 2.5MG;2.5MG;2.5MG;2.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2001-10-11 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021303-002 | ADDERALL XR 20 | 5MG;5MG;5MG;5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2001-10-11 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021303-003 | ADDERALL XR 30 | 7.5MG;7.5MG;7.5MG;7.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD, RS | 2001-10-11 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021303-004 | ADDERALL XR 25 | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-05-22 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021303-005 | ADDERALL XR 5 | 1.25MG;1.25MG;1.25MG;1.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-05-22 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021303-006 | ADDERALL XR 15 | 3.75MG;3.75MG;3.75MG;3.75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-05-22 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021303-001 | ADDERALL XR 10 | 2.5MG;2.5MG;2.5MG;2.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2001-10-11 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021303-002 | ADDERALL XR 20 | 5MG;5MG;5MG;5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2001-10-11 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021303-003 | ADDERALL XR 30 | 7.5MG;7.5MG;7.5MG;7.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD, RS | 2001-10-11 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021303-004 | ADDERALL XR 25 | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-05-22 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021303-005 | ADDERALL XR 5 | 1.25MG;1.25MG;1.25MG;1.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-05-22 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021303-006 | ADDERALL XR 15 | 3.75MG;3.75MG;3.75MG;3.75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-05-22 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021303-001 | ADDERALL XR 10 | 2.5MG;2.5MG;2.5MG;2.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2001-10-11 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021303-002 | ADDERALL XR 20 | 5MG;5MG;5MG;5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2001-10-11 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021303-003 | ADDERALL XR 30 | 7.5MG;7.5MG;7.5MG;7.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD, RS | 2001-10-11 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021303-004 | ADDERALL XR 25 | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-05-22 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021303-005 | ADDERALL XR 5 | 1.25MG;1.25MG;1.25MG;1.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-05-22 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021303-006 | ADDERALL XR 15 | 3.75MG;3.75MG;3.75MG;3.75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-05-22 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021303-001 | ADDERALL XR 10 | 2.5MG;2.5MG;2.5MG;2.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2001-10-11 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021303-002 | ADDERALL XR 20 | 5MG;5MG;5MG;5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2001-10-11 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021303-003 | ADDERALL XR 30 | 7.5MG;7.5MG;7.5MG;7.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD, RS | 2001-10-11 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021303-004 | ADDERALL XR 25 | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-05-22 | b8a1b40f171c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N021303-001 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021303-002 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021303-003 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021303-004 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021303-005 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021303-006 | AB1 | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N021303-001 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021303-002 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021303-003 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021303-004 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021303-005 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021303-006 | AB1 | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N021303-001 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021303-002 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021303-003 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021303-004 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021303-005 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021303-006 | AB1 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021303-001 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021303-002 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021303-003 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021303-004 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021303-005 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021303-006 | AB1 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021303-001 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021303-002 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021303-003 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021303-004 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021303-005 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021303-006 | AB1 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021303-001 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021303-002 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021303-003 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021303-004 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021303-005 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021303-006 | AB1 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021303-001 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021303-002 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021303-003 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021303-004 | AB1 | 1 | b8a1b40f171c… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N021303-001 | 6322819*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021303-001 | 6605300*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021303-001 | RE41148*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021303-001 | RE42096*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021303-002 | 6322819*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021303-002 | 6605300*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021303-002 | RE41148*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021303-002 | RE42096*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021303-003 | 6322819*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021303-003 | 6605300*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021303-003 | RE41148*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021303-003 | RE42096*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021303-004 | 6322819*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021303-004 | 6605300*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021303-004 | RE41148*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021303-004 | RE42096*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021303-005 | 6322819*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021303-005 | 6605300*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021303-005 | RE41148*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021303-005 | RE42096*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021303-006 | 6322819*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021303-006 | 6605300*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021303-006 | RE41148*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021303-006 | RE42096*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021303-001 | 6322819*PED | 2019-04-21 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021303-001 | 6605300*PED | 2019-04-21 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021303-001 | RE41148*PED | 2019-04-21 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021303-001 | RE42096*PED | 2019-04-21 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021303-002 | 6322819*PED | 2019-04-21 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021303-002 | 6605300*PED | 2019-04-21 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021303-002 | RE41148*PED | 2019-04-21 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021303-002 | RE42096*PED | 2019-04-21 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021303-003 | 6322819*PED | 2019-04-21 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021303-003 | 6605300*PED | 2019-04-21 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021303-003 | RE41148*PED | 2019-04-21 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021303-003 | RE42096*PED | 2019-04-21 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021303-004 | 6322819*PED | 2019-04-21 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021303-004 | 6605300*PED | 2019-04-21 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021303-004 | RE41148*PED | 2019-04-21 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021303-004 | RE42096*PED | 2019-04-21 | Pediatric extension | 3f01610625f2… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.