Pillstats
Rx only · Tablet, Extended Release · Oral

Theophylline

Theophylline Anhydrous

17 ACTIVE SUPPLIERS — US
openFDA · updated weekly
US38 NDCs
17 active makers
UKComing
soon
CAComing
soon
AUComing
soon
EUComing
soon
ATCR03DA04
RxCUI (US)10438
US makers18 labelers
Packages63
DEA / ScheduleNone

US acquisition costNADAC · per unit

Average across 22 priced NDCs. A benchmark of pharmacy acquisition cost — not a retail quote.

$0.401$0.802$1.20$1.60Nov 2025Mar 2026Jul 2026
$0.673
Latest avg · Jul 22, 2026
-52%
Since Nov 19, 2025
17
Active US suppliers
41%
Top-2 supplier share*

Medicaid dispensing volumeSDUD · per quarter

Prescriptions dispensed under Medicaid (fee-for-service + managed care), summed nationally. The closest free proxy to sales volume — Medicaid only, not all-payer.

2.8K5.5K8.3K11K2025 Q12025 Q22025 Q32025 Q42026 Q1
6.2K
Rx · 2026 Q1
325K
Units dispensed
-35%
Rx vs. year ago
5
Quarters · since 2025 Q1

Who makes it17 active · 1 exited

US labelers as registered with FDA. Repackagers relabel another company's product; share* is of listed packages, not sales.

LabelerTypePackagesStatus
Alembic Pharmaceuticals Limitedunknown14SUPPLYING
Glenmark Pharmaceuticals Inc., USAunknown11SUPPLYING
Amneal Pharmaceuticals LLCunknown7SUPPLYING
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.unknown5SUPPLYING
Brandywine Pharmaceuticals, LLCunknown3SUPPLYING
Viona Pharmaceuticals Incunknown2SUPPLYING
Camber Pharmaceuticals, Inc.unknown2SUPPLYING
Ajanta Pharma USA Inc.unknown2SUPPLYING
PD-Rx Pharmaceuticals, Inc.unknown2SUPPLYING
Teva Pharmaceuticals USA, Inc.unknown2SUPPLYING
Harman Finochem Limitedunknown2SUPPLYING
Zydus Lifesciences Limitedunknown2SUPPLYING
Strides Pharma Science Limitedunknown2SUPPLYING
Leading Pharma, LLCunknown2SUPPLYING
AvKAREunknown1SUPPLYING

+ 3 more labelers

Regulatory & supply eventsFDA · US

Shortages, recalls, and registration changes attached to this drug concept.

  • Aug 8, 2025
    RECALLRecall (Class II): Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Limit…

    Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do not comply with L3 stage dissolution criteria. — Recalling firm: Glenmark Pharmaceuticals Inc., USA — USA nationwide.

  • May 15, 2025
    RECALLRecall (Class II): Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Glenmark P…

    OOS results reported for the Dissolution (by UV) test. — Recalling firm: Glenmark Pharmaceuticals Inc., USA — Nationwide in the USA

  • Mar 15, 2021
    RECALLRecall (Class II): Theophylline (Anhydrous) Extended-Release Tablets 400 mg 100 Tablets Rx Only NDC 68462-380-01 Manufactured by: Glenmark…

    CGMP Deviations: Intermittent exposure to temperature excursion during storage. — Recalling firm: Cardinal Health Inc. — FL, GA, SC