Home NDC 64380-244 Theophylline
Product NDC 64380-244
11-digit product format 643800244
Labeler code 64380
Product ID 64380-244_86a861fa-5c70-432e-8c0b-6e7241af5e82
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Theophylline
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Labeler Strides Pharma Science Limited
Application ANDA215312
Marketing category ANDA
Marketing start 2024-09-27
Substance THEOPHYLLINE ANHYDROUS
Active strength 450 mg/1
Pharmacologic classes Methylxanthine [EPC], Xanthines [CS]
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215312-001 THEOPHYLLINE THEOPHYLLINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2024-09-05 A215312-002 THEOPHYLLINE THEOPHYLLINE 450MG TABLET, EXTENDED RELEASE / ORAL AB 2024-09-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A215312-001 THEOPHYLLINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2024-09-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215312-002 THEOPHYLLINE 450MG TABLET, EXTENDED RELEASE / ORAL AB 2024-09-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215312-001 THEOPHYLLINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2024-09-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215312-002 THEOPHYLLINE 450MG TABLET, EXTENDED RELEASE / ORAL AB 2024-09-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215312-001 THEOPHYLLINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2024-09-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215312-002 THEOPHYLLINE 450MG TABLET, EXTENDED RELEASE / ORAL AB 2024-09-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215312-001 THEOPHYLLINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2024-09-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215312-002 THEOPHYLLINE 450MG TABLET, EXTENDED RELEASE / ORAL AB 2024-09-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215312-001 THEOPHYLLINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2024-09-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215312-002 THEOPHYLLINE 450MG TABLET, EXTENDED RELEASE / ORAL AB 2024-09-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215312-001 THEOPHYLLINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2024-09-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215312-002 THEOPHYLLINE 450MG TABLET, EXTENDED RELEASE / ORAL AB 2024-09-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215312-001 THEOPHYLLINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2024-09-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215312-002 THEOPHYLLINE 450MG TABLET, EXTENDED RELEASE / ORAL AB 2024-09-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215312-001 THEOPHYLLINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2024-09-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215312-002 THEOPHYLLINE 450MG TABLET, EXTENDED RELEASE / ORAL AB 2024-09-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215312-001 THEOPHYLLINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2024-09-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215312-002 THEOPHYLLINE 450MG TABLET, EXTENDED RELEASE / ORAL AB 2024-09-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215312-001 THEOPHYLLINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2024-09-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215312-002 THEOPHYLLINE 450MG TABLET, EXTENDED RELEASE / ORAL AB 2024-09-05 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215312-001 THEOPHYLLINE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2024-09-05 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215312-002 THEOPHYLLINE 450MG TABLET, EXTENDED RELEASE / ORAL AB 2024-09-05 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215312-001 CGT 2025-03-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215312-001 CGT 2025-03-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215312-001 CGT 2025-03-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215312-001 CGT 2025-03-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215312-001 CGT 2025-03-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215312-001 CGT 2025-03-26 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215312-001 CGT 2025-03-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215312-001 CGT 2025-03-26 d06236e962d9…
Additional Listing Data#
Finished product Yes
Brand name base Theophylline
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength THEOPHYLLINE ANHYDROUS 450 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0I55128JYK Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 314241 Internal RxNorm lookup 317769 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64380-244-01 Theophylline 100 in 1 BOTTLE TABLET, EXTENDED RELEASE 100 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64380-244 THEOPHYLLINE TABLET, EXTENDED RELEASE [STRIDES PHARMA SCIENCE LIMITED] 3 Current NDC, 1 package rows 20240927_b7a90ccf-9c32-40cc-9008-7e55b3da4dfd.zip
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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 64380-244-01 64380024401 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (64380-244-01) 2024-09-27 No No Current