FDA.reportPublic FDA data

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 02:12:27

Label at a glance#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0228-3064-11EA - Each0228-30648a2fd2fa-ff33-4a89-8c06-35dccb0fb38e12012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0228-30640228-3064-11

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077302-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE1.25MG;1.25MG;1.25MG;1.25MGCAPSULE, EXTENDED RELEASE / ORALAB12012-06-22
A077302-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE2.5MG;2.5MG;2.5MG;2.5MGCAPSULE, EXTENDED RELEASE / ORALAB12012-06-22
A077302-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE3.75MG;3.75MG;3.75MG;3.75MGCAPSULE, EXTENDED RELEASE / ORALAB12012-06-22
A077302-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE5MG;5MG;5MG;5MGCAPSULE, EXTENDED RELEASE / ORALAB12012-06-22
A077302-005DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE6.25MG;6.25MG;6.25MG;6.25MGCAPSULE, EXTENDED RELEASE / ORALAB12012-06-22
A077302-006DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE7.5MG;7.5MG;7.5MG;7.5MGCAPSULE, EXTENDED RELEASE / ORALAB12012-06-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
A077302-001AB1
A077302-002AB1
A077302-003AB1
A077302-004AB1
A077302-005AB1
A077302-006AB1

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.

Product history page 1 of 7 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077302-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.25MG;1.25MG;1.25MG;1.25MGCAPSULE, EXTENDED RELEASE / ORALAB12012-06-2284e616aacf4f…
2026-09-14 22:38:342026-08A077302-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE2.5MG;2.5MG;2.5MG;2.5MGCAPSULE, EXTENDED RELEASE / ORALAB12012-06-2284e616aacf4f…
2026-09-14 22:38:342026-08A077302-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.75MG;3.75MG;3.75MG;3.75MGCAPSULE, EXTENDED RELEASE / ORALAB12012-06-2284e616aacf4f…
2026-09-14 22:38:342026-08A077302-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE5MG;5MG;5MG;5MGCAPSULE, EXTENDED RELEASE / ORALAB12012-06-2284e616aacf4f…
2026-09-14 22:38:342026-08A077302-005DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE6.25MG;6.25MG;6.25MG;6.25MGCAPSULE, EXTENDED RELEASE / ORALAB12012-06-2284e616aacf4f…
2026-09-14 22:38:342026-08A077302-006DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE7.5MG;7.5MG;7.5MG;7.5MGCAPSULE, EXTENDED RELEASE / ORALAB12012-06-2284e616aacf4f…
2026-08-18 06:07:402026-07A077302-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.25MG;1.25MG;1.25MG;1.25MGCAPSULE, EXTENDED RELEASE / ORALAB12012-06-22caaa826d4ba7…
2026-08-18 06:07:402026-07A077302-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE2.5MG;2.5MG;2.5MG;2.5MGCAPSULE, EXTENDED RELEASE / ORALAB12012-06-22caaa826d4ba7…
2026-08-18 06:07:402026-07A077302-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.75MG;3.75MG;3.75MG;3.75MGCAPSULE, EXTENDED RELEASE / ORALAB12012-06-22caaa826d4ba7…
2026-08-18 06:07:402026-07A077302-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE5MG;5MG;5MG;5MGCAPSULE, EXTENDED RELEASE / ORALAB12012-06-22caaa826d4ba7…
2026-08-18 06:07:402026-07A077302-005DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE6.25MG;6.25MG;6.25MG;6.25MGCAPSULE, EXTENDED RELEASE / ORALAB12012-06-22caaa826d4ba7…
2026-08-18 06:07:402026-07A077302-006DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE7.5MG;7.5MG;7.5MG;7.5MGCAPSULE, EXTENDED RELEASE / ORALAB12012-06-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077302-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.25MG;1.25MG;1.25MG;1.25MGCAPSULE, EXTENDED RELEASE / ORALAB12012-06-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077302-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE2.5MG;2.5MG;2.5MG;2.5MGCAPSULE, EXTENDED RELEASE / ORALAB12012-06-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077302-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.75MG;3.75MG;3.75MG;3.75MGCAPSULE, EXTENDED RELEASE / ORALAB12012-06-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077302-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE5MG;5MG;5MG;5MGCAPSULE, EXTENDED RELEASE / ORALAB12012-06-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077302-005DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE6.25MG;6.25MG;6.25MG;6.25MGCAPSULE, EXTENDED RELEASE / ORALAB12012-06-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077302-006DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE7.5MG;7.5MG;7.5MG;7.5MGCAPSULE, EXTENDED RELEASE / ORALAB12012-06-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077302-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.25MG;1.25MG;1.25MG;1.25MGCAPSULE, EXTENDED RELEASE / ORALAB12012-06-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077302-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE2.5MG;2.5MG;2.5MG;2.5MGCAPSULE, EXTENDED RELEASE / ORALAB12012-06-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077302-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.75MG;3.75MG;3.75MG;3.75MGCAPSULE, EXTENDED RELEASE / ORALAB12012-06-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077302-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE5MG;5MG;5MG;5MGCAPSULE, EXTENDED RELEASE / ORALAB12012-06-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077302-005DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE6.25MG;6.25MG;6.25MG;6.25MGCAPSULE, EXTENDED RELEASE / ORALAB12012-06-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077302-006DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE7.5MG;7.5MG;7.5MG;7.5MGCAPSULE, EXTENDED RELEASE / ORALAB12012-06-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A077302-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.25MG;1.25MG;1.25MG;1.25MGCAPSULE, EXTENDED RELEASE / ORALAB12012-06-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077302-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE2.5MG;2.5MG;2.5MG;2.5MGCAPSULE, EXTENDED RELEASE / ORALAB12012-06-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077302-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.75MG;3.75MG;3.75MG;3.75MGCAPSULE, EXTENDED RELEASE / ORALAB12012-06-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077302-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE5MG;5MG;5MG;5MGCAPSULE, EXTENDED RELEASE / ORALAB12012-06-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077302-005DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE6.25MG;6.25MG;6.25MG;6.25MGCAPSULE, EXTENDED RELEASE / ORALAB12012-06-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077302-006DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE7.5MG;7.5MG;7.5MG;7.5MGCAPSULE, EXTENDED RELEASE / ORALAB12012-06-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077302-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.25MG;1.25MG;1.25MG;1.25MGCAPSULE, EXTENDED RELEASE / ORALAB12012-06-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077302-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE2.5MG;2.5MG;2.5MG;2.5MGCAPSULE, EXTENDED RELEASE / ORALAB12012-06-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077302-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.75MG;3.75MG;3.75MG;3.75MGCAPSULE, EXTENDED RELEASE / ORALAB12012-06-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077302-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE5MG;5MG;5MG;5MGCAPSULE, EXTENDED RELEASE / ORALAB12012-06-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077302-005DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE6.25MG;6.25MG;6.25MG;6.25MGCAPSULE, EXTENDED RELEASE / ORALAB12012-06-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077302-006DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE7.5MG;7.5MG;7.5MG;7.5MGCAPSULE, EXTENDED RELEASE / ORALAB12012-06-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077302-001DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE1.25MG;1.25MG;1.25MG;1.25MGCAPSULE, EXTENDED RELEASE / ORALAB12012-06-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077302-002DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE2.5MG;2.5MG;2.5MG;2.5MGCAPSULE, EXTENDED RELEASE / ORALAB12012-06-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077302-003DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE3.75MG;3.75MG;3.75MG;3.75MGCAPSULE, EXTENDED RELEASE / ORALAB12012-06-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077302-004DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE5MG;5MG;5MG;5MGCAPSULE, EXTENDED RELEASE / ORALAB12012-06-22b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A077302-001AB1184e616aacf4f…
2026-09-14 22:38:342026-08A077302-002AB1184e616aacf4f…
2026-09-14 22:38:342026-08A077302-003AB1184e616aacf4f…
2026-09-14 22:38:342026-08A077302-004AB1184e616aacf4f…
2026-09-14 22:38:342026-08A077302-005AB1184e616aacf4f…
2026-09-14 22:38:342026-08A077302-006AB1184e616aacf4f…
2026-08-18 06:07:402026-07A077302-001AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A077302-002AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A077302-003AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A077302-004AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A077302-005AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A077302-006AB11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077302-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077302-002AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077302-003AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077302-004AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077302-005AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077302-006AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077302-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077302-002AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077302-003AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077302-004AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077302-005AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077302-006AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077302-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077302-002AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077302-003AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077302-004AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077302-005AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077302-006AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077302-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077302-002AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077302-003AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077302-004AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077302-005AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077302-006AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077302-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077302-002AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077302-003AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077302-004AB11b8a1b40f171c…

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATEActavis Pharma, Inc.c5c2d060-452c-4f76-ad93-2e41fd8f06c22026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 0228-3064-11
ndc11 (package): 00228306411

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.