DEXMETHYLPHENIDATE HYDROCHLORIDE

Product NDC
70010-005
11-digit product format
700100005
Labeler code
70010
Product ID
70010-005_5d4e3549-d093-0608-e063-6394a90aee16
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEXMETHYLPHENIDATE HYDROCHLORIDE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Granules Pharmaceuticals Inc.
Application
ANDA213813
Marketing category
ANDA
Marketing start
2020-12-01
Substance
DEXMETHYLPHENIDATE HYDROCHLORIDE
Active strength
10 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 43.

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213813-001DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDE5MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-09
A213813-002DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-09
A213813-003DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-09
A213813-004DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDE20MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-09
A213813-005DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDE25MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-09
A213813-006DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-09
A213813-007DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDE35MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-09
A213813-008DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 8 matching rows.

Application-product, TE code table
Application-productTE code
A213813-001AB
A213813-002AB
A213813-003AB
A213813-004AB
A213813-005AB
A213813-006AB
A213813-007AB
A213813-008AB

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 8 · 312 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A213813-001DEXMETHYLPHENIDATE HYDROCHLORIDE5MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-0984e616aacf4f…
2026-09-14 22:38:342026-08A213813-002DEXMETHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-0984e616aacf4f…
2026-09-14 22:38:342026-08A213813-003DEXMETHYLPHENIDATE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-0984e616aacf4f…
2026-09-14 22:38:342026-08A213813-004DEXMETHYLPHENIDATE HYDROCHLORIDE20MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-0984e616aacf4f…
2026-09-14 22:38:342026-08A213813-005DEXMETHYLPHENIDATE HYDROCHLORIDE25MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-0984e616aacf4f…
2026-09-14 22:38:342026-08A213813-006DEXMETHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-0984e616aacf4f…
2026-09-14 22:38:342026-08A213813-007DEXMETHYLPHENIDATE HYDROCHLORIDE35MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-0984e616aacf4f…
2026-09-14 22:38:342026-08A213813-008DEXMETHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-0984e616aacf4f…
2026-08-18 06:07:402026-07A213813-001DEXMETHYLPHENIDATE HYDROCHLORIDE5MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-09caaa826d4ba7…
2026-08-18 06:07:402026-07A213813-002DEXMETHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-09caaa826d4ba7…
2026-08-18 06:07:402026-07A213813-003DEXMETHYLPHENIDATE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-09caaa826d4ba7…
2026-08-18 06:07:402026-07A213813-004DEXMETHYLPHENIDATE HYDROCHLORIDE20MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-09caaa826d4ba7…
2026-08-18 06:07:402026-07A213813-005DEXMETHYLPHENIDATE HYDROCHLORIDE25MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-09caaa826d4ba7…
2026-08-18 06:07:402026-07A213813-006DEXMETHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-09caaa826d4ba7…
2026-08-18 06:07:402026-07A213813-007DEXMETHYLPHENIDATE HYDROCHLORIDE35MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-09caaa826d4ba7…
2026-08-18 06:07:402026-07A213813-008DEXMETHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213813-001DEXMETHYLPHENIDATE HYDROCHLORIDE5MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213813-002DEXMETHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213813-003DEXMETHYLPHENIDATE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213813-004DEXMETHYLPHENIDATE HYDROCHLORIDE20MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213813-005DEXMETHYLPHENIDATE HYDROCHLORIDE25MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213813-006DEXMETHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213813-007DEXMETHYLPHENIDATE HYDROCHLORIDE35MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213813-008DEXMETHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213813-001DEXMETHYLPHENIDATE HYDROCHLORIDE5MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213813-002DEXMETHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213813-003DEXMETHYLPHENIDATE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213813-004DEXMETHYLPHENIDATE HYDROCHLORIDE20MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213813-005DEXMETHYLPHENIDATE HYDROCHLORIDE25MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213813-006DEXMETHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213813-007DEXMETHYLPHENIDATE HYDROCHLORIDE35MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213813-008DEXMETHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A213813-001DEXMETHYLPHENIDATE HYDROCHLORIDE5MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213813-002DEXMETHYLPHENIDATE HYDROCHLORIDE10MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213813-003DEXMETHYLPHENIDATE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213813-004DEXMETHYLPHENIDATE HYDROCHLORIDE20MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213813-005DEXMETHYLPHENIDATE HYDROCHLORIDE25MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213813-006DEXMETHYLPHENIDATE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213813-007DEXMETHYLPHENIDATE HYDROCHLORIDE35MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213813-008DEXMETHYLPHENIDATE HYDROCHLORIDE40MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-096a471c1ec25d…

Observed Orange Book normalized TE history#

Normalized TE history page 7 of 8 · 312 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213813-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213813-002AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213813-003AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213813-004AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213813-005AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213813-006AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213813-007AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213813-008AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213813-001AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213813-002AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213813-003AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213813-004AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213813-005AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213813-006AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213813-007AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213813-008AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A213813-001AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A213813-002AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A213813-003AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A213813-004AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A213813-005AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A213813-006AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A213813-007AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A213813-008AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A213813-001AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A213813-002AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A213813-003AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A213813-004AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A213813-005AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A213813-006AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A213813-007AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A213813-008AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213813-001AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213813-002AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213813-003AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213813-004AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213813-005AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213813-006AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213813-007AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213813-008AB13a93d1ddd44b…

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
DEXMETHYLPHENIDATE HYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXMETHYLPHENIDATE HYDROCHLORIDE10 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1ff349b0-f325-4585-9c0d-7dc58eb1bc1bProduct name120210818
7d5b6b15-5a1e-e1e5-992d-90d0701572adProduct name920210511
ccfbb2ac-2915-4b21-1d79-8a93f773e70fProduct name920200714

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70010-005-01DEXMETHYLPHENIDATE HYDROCHLORIDE100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70010-005-01EA - Each70010-005f51c5143-881c-416e-b016-fff0b855284812021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-005DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [GRANULES PHARMACEUTICALS INC.]8Current NDC, Legacy NDC, 1 package rows20231111_abe6862b-3cf3-4aad-98ea-05a5fb54ebec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
899439dexmethylphenidate HCl 10 MG 24HR Extended Release Oral CapsulePSNabe6862b-3cf3-4aad-98ea-05a5fb54ebec9
899461dexmethylphenidate HCl 15 MG 24HR Extended Release Oral CapsulePSNabe6862b-3cf3-4aad-98ea-05a5fb54ebec9
899485dexmethylphenidate HCl 20 MG 24HR Extended Release Oral CapsulePSNabe6862b-3cf3-4aad-98ea-05a5fb54ebec9
1101926dexmethylphenidate HCl 25 MG 24HR Extended Release Oral CapsulePSNabe6862b-3cf3-4aad-98ea-05a5fb54ebec9
899495dexmethylphenidate HCl 30 MG 24HR Extended Release Oral CapsulePSNabe6862b-3cf3-4aad-98ea-05a5fb54ebec9
1101932dexmethylphenidate HCl 35 MG 24HR Extended Release Oral CapsulePSNabe6862b-3cf3-4aad-98ea-05a5fb54ebec9
1006608dexmethylphenidate HCl 40 MG 24HR Extended Release Oral CapsulePSNabe6862b-3cf3-4aad-98ea-05a5fb54ebec9
899511dexmethylphenidate HCl 5 MG 24HR Extended Release Oral CapsulePSNabe6862b-3cf3-4aad-98ea-05a5fb54ebec9
89943924 HR dexmethylphenidate hydrochloride 10 MG Extended Release Oral CapsuleSCDabe6862b-3cf3-4aad-98ea-05a5fb54ebec9
89946124 HR dexmethylphenidate hydrochloride 15 MG Extended Release Oral CapsuleSCDabe6862b-3cf3-4aad-98ea-05a5fb54ebec9
89948524 HR dexmethylphenidate hydrochloride 20 MG Extended Release Oral CapsuleSCDabe6862b-3cf3-4aad-98ea-05a5fb54ebec9
110192624 HR dexmethylphenidate hydrochloride 25 MG Extended Release Oral CapsuleSCDabe6862b-3cf3-4aad-98ea-05a5fb54ebec9
89949524 HR dexmethylphenidate hydrochloride 30 MG Extended Release Oral CapsuleSCDabe6862b-3cf3-4aad-98ea-05a5fb54ebec9
110193224 HR dexmethylphenidate hydrochloride 35 MG Extended Release Oral CapsuleSCDabe6862b-3cf3-4aad-98ea-05a5fb54ebec9
100660824 HR dexmethylphenidate hydrochloride 40 MG Extended Release Oral CapsuleSCDabe6862b-3cf3-4aad-98ea-05a5fb54ebec9
89951124 HR dexmethylphenidate hydrochloride 5 MG Extended Release Oral CapsuleSCDabe6862b-3cf3-4aad-98ea-05a5fb54ebec9
899439dexmethylphenidate hydrochloride 10 MG 24 HR Extended Release Oral CapsuleSYabe6862b-3cf3-4aad-98ea-05a5fb54ebec9
899461dexmethylphenidate hydrochloride 15 MG 24 HR Extended Release Oral CapsuleSYabe6862b-3cf3-4aad-98ea-05a5fb54ebec9
899485dexmethylphenidate hydrochloride 20 MG 24 HR Extended Release Oral CapsuleSYabe6862b-3cf3-4aad-98ea-05a5fb54ebec9
1101926dexmethylphenidate hydrochloride 25 MG 24 HR Extended Release Oral CapsuleSYabe6862b-3cf3-4aad-98ea-05a5fb54ebec9
899495dexmethylphenidate hydrochloride 30 MG 24 HR Extended Release Oral CapsuleSYabe6862b-3cf3-4aad-98ea-05a5fb54ebec9
1101932dexmethylphenidate hydrochloride 35 MG 24 HR Extended Release Oral CapsuleSYabe6862b-3cf3-4aad-98ea-05a5fb54ebec9
1006608dexmethylphenidate hydrochloride 40 MG 24 HR Extended Release Oral CapsuleSYabe6862b-3cf3-4aad-98ea-05a5fb54ebec9
899511dexmethylphenidate hydrochloride 5 MG 24 HR Extended Release Oral CapsuleSYabe6862b-3cf3-4aad-98ea-05a5fb54ebec9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70010-005-0170010000501100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-005-01) 2020-12-010000-00-00NoNoCurrent