Amphetamine

Product NDC
0480-3319
11-digit product format
004803319
Labeler code
0480
Product ID
0480-3319_4373ba4a-1fee-46df-bba9-b60e42cfd15a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amphetamine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Teva Pharmaceuticals, Inc.
Application
ANDA209253
Marketing category
ANDA
Marketing start
2025-12-08
Substance
AMPHETAMINE
Active strength
15.7 mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A209253-001AMPHETAMINEAMPHETAMINEEQ 3.1MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORALAB2023-06-22
A209253-002AMPHETAMINEAMPHETAMINEEQ 6.3MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORALAB2023-06-22
A209253-003AMPHETAMINEAMPHETAMINEEQ 9.4MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORALAB2023-06-22
A209253-004AMPHETAMINEAMPHETAMINEEQ 12.5MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORALAB2023-06-22
A209253-005AMPHETAMINEAMPHETAMINEEQ 15.7MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORALAB2023-06-22
A209253-006AMPHETAMINEAMPHETAMINEEQ 18.8MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORALAB2023-06-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209253-001AB
A209253-002AB
A209253-003AB
A209253-004AB
A209253-005AB
A209253-006AB

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 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A209253-001AMPHETAMINEEQ 3.1MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORALAB2023-06-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209253-002AMPHETAMINEEQ 6.3MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORALAB2023-06-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209253-003AMPHETAMINEEQ 9.4MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORALAB2023-06-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209253-004AMPHETAMINEEQ 12.5MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORALAB2023-06-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209253-005AMPHETAMINEEQ 15.7MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORALAB2023-06-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209253-006AMPHETAMINEEQ 18.8MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORALAB2023-06-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209253-001AMPHETAMINEEQ 3.1MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORALAB2023-06-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209253-002AMPHETAMINEEQ 6.3MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORALAB2023-06-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209253-003AMPHETAMINEEQ 9.4MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORALAB2023-06-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209253-004AMPHETAMINEEQ 12.5MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORALAB2023-06-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209253-005AMPHETAMINEEQ 15.7MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORALAB2023-06-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209253-006AMPHETAMINEEQ 18.8MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORALAB2023-06-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A209253-001AMPHETAMINEEQ 3.1MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORALAB2023-06-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209253-002AMPHETAMINEEQ 6.3MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORALAB2023-06-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209253-003AMPHETAMINEEQ 9.4MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORALAB2023-06-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209253-004AMPHETAMINEEQ 12.5MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORALAB2023-06-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209253-005AMPHETAMINEEQ 15.7MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORALAB2023-06-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209253-006AMPHETAMINEEQ 18.8MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORALAB2023-06-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209253-001AMPHETAMINEEQ 3.1MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209253-002AMPHETAMINEEQ 6.3MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209253-003AMPHETAMINEEQ 9.4MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209253-004AMPHETAMINEEQ 12.5MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209253-005AMPHETAMINEEQ 15.7MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209253-006AMPHETAMINEEQ 18.8MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209253-001AMPHETAMINEEQ 3.1MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209253-002AMPHETAMINEEQ 6.3MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209253-003AMPHETAMINEEQ 9.4MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209253-004AMPHETAMINEEQ 12.5MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209253-005AMPHETAMINEEQ 15.7MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209253-006AMPHETAMINEEQ 18.8MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209253-001AMPHETAMINEEQ 3.1MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209253-002AMPHETAMINEEQ 6.3MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209253-003AMPHETAMINEEQ 9.4MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209253-004AMPHETAMINEEQ 12.5MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209253-005AMPHETAMINEEQ 15.7MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209253-006AMPHETAMINEEQ 18.8MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209253-001AMPHETAMINEEQ 3.1MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209253-002AMPHETAMINEEQ 6.3MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209253-003AMPHETAMINEEQ 9.4MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209253-004AMPHETAMINEEQ 12.5MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL2023-06-222680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A209253-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209253-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209253-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209253-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209253-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209253-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209253-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209253-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209253-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209253-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209253-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209253-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209253-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209253-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209253-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209253-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209253-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209253-006AB16a471c1ec25d…
2023-12-20 04:57 UTC2023-12A209253-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A209253-002AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A209253-003AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A209253-004AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A209253-005AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A209253-006AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209253-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209253-002AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209253-003AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209253-004AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209253-005AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209253-006AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209253-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209253-002AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209253-003AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209253-004AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209253-005AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209253-006AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209253-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209253-002AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209253-003AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209253-004AB1a67488948f0b…

Additional Listing Data#

Finished product
Yes
Brand name base
Amphetamine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMPHETAMINE15.7 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
CK833KGX7EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1739803Internal RxNorm lookup
1739813Internal RxNorm lookup
1739819Internal RxNorm lookup
1739825Internal RxNorm lookup
1739831Internal RxNorm lookup
1739837Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
243e88e7-6621-47e9-8d5c-3f79bcb088bbAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0f66b30d-6b15-4b2d-91a5-1531b9bb6d21Product name720250625
917bdf48-c3f5-4a58-ac8e-d2d94a9c1e2bProduct name220250616
8b92ab59-8b26-4c89-a2d6-8d5140526ec6Product name320231213
4496d022-9224-4ee0-943a-50fbe6cd7123Product name220220901
2a7aa275-a4ca-44eb-971f-47427a374085Product name920220615
93730fbf-8b45-4623-b27d-cf03825d04b3Product name520220314
57953747-955c-4dd8-9164-49d8ea877eaeProduct name120171113
fcc7ea58-a369-4e91-b092-5cde9ac2669fProduct name120160224

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0480-3319-65Amphetamine6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING62
0480-3319-65Amphetamine30 in 1 CARTONTABLET, ORALLY DISINTEGRATING302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0480-3319-65EA - Each0480-3319dc1629f0-075f-4276-aae1-db7b5d10634012026-01-08

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
AmphetamineAMPHETAMINETeva Pharmaceuticals, Inc.243e88e7-6621-47e9-8d5c-3f79bcb088bb2025-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209253
application number: ANDA209253
ndc (product): 0480-3319

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1739803amphetamine 12.5 MG 24HR Extended Release Distintegrating Oral TabletPSN243e88e7-6621-47e9-8d5c-3f79bcb088bb2
1739813amphetamine 15.7 MG 24HR Extended Release Distintegrating Oral TabletPSN243e88e7-6621-47e9-8d5c-3f79bcb088bb2
1739819amphetamine 18.8 MG 24HR Extended Release Distintegrating Oral TabletPSN243e88e7-6621-47e9-8d5c-3f79bcb088bb2
1739825amphetamine 3.1 MG 24HR Extended Release Distintegrating Oral TabletPSN243e88e7-6621-47e9-8d5c-3f79bcb088bb2
1739831amphetamine 6.3 MG 24HR Extended Release Distintegrating Oral TabletPSN243e88e7-6621-47e9-8d5c-3f79bcb088bb2
1739837amphetamine 9.4 MG 24HR Extended Release Distintegrating Oral TabletPSN243e88e7-6621-47e9-8d5c-3f79bcb088bb2
173980324 HR amphetamine 12.5 MG Extended Release Oral TabletSCD243e88e7-6621-47e9-8d5c-3f79bcb088bb2
173981324 HR amphetamine 15.7 MG Extended Release Oral TabletSCD243e88e7-6621-47e9-8d5c-3f79bcb088bb2
173981924 HR amphetamine 18.8 MG Extended Release Oral TabletSCD243e88e7-6621-47e9-8d5c-3f79bcb088bb2
173982524 HR amphetamine 3.1 MG Extended Release Oral TabletSCD243e88e7-6621-47e9-8d5c-3f79bcb088bb2
173983124 HR amphetamine 6.3 MG Extended Release Oral TabletSCD243e88e7-6621-47e9-8d5c-3f79bcb088bb2
173983724 HR amphetamine 9.4 MG Extended Release Oral TabletSCD243e88e7-6621-47e9-8d5c-3f79bcb088bb2
1739803amphetamine 12.5 MG 24 HR Extended Release Distintegrating Oral TabletSY243e88e7-6621-47e9-8d5c-3f79bcb088bb2
1739813amphetamine 15.7 MG 24 HR Extended Release Distintegrating Oral TabletSY243e88e7-6621-47e9-8d5c-3f79bcb088bb2
1739819amphetamine 18.8 MG 24 HR Extended Release Distintegrating Oral TabletSY243e88e7-6621-47e9-8d5c-3f79bcb088bb2
1739825amphetamine 3.1 MG 24 HR Extended Release Distintegrating Oral TabletSY243e88e7-6621-47e9-8d5c-3f79bcb088bb2
1739831amphetamine 6.3 MG 24 HR Extended Release Distintegrating Oral TabletSY243e88e7-6621-47e9-8d5c-3f79bcb088bb2
1739837amphetamine 9.4 MG 24 HR Extended Release Distintegrating Oral TabletSY243e88e7-6621-47e9-8d5c-3f79bcb088bb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0480-3319-650048033196530 BLISTER PACK in 1 CARTON (0480-3319-65) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK30 blister pack2025-12-08NoNoCurrent