FDA.reportPublic FDA data

Theophylline

Product NDC
27241-273
11-digit product format
272410273
Labeler code
27241
Product ID
27241-273_fbec14fb-bd76-48e7-b61f-b19cd1a3ea2f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Theophylline
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA218401
Marketing category
ANDA
Marketing start
2025-01-13
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218401-001THEOPHYLLINETHEOPHYLLINE450MGTABLET, EXTENDED RELEASE / ORAL2025-01-13
A218401-002THEOPHYLLINETHEOPHYLLINE300MGTABLET, EXTENDED RELEASE / ORAL2025-03-26

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A218401-001THEOPHYLLINE450MGTABLET, EXTENDED RELEASE / ORAL2025-01-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218401-002THEOPHYLLINE300MGTABLET, EXTENDED RELEASE / ORAL2025-03-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218401-001THEOPHYLLINE450MGTABLET, EXTENDED RELEASE / ORAL2025-01-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218401-002THEOPHYLLINE300MGTABLET, EXTENDED RELEASE / ORAL2025-03-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A218401-001THEOPHYLLINE450MGTABLET, EXTENDED RELEASE / ORAL2025-01-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218401-002THEOPHYLLINE300MGTABLET, EXTENDED RELEASE / ORAL2025-03-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218401-001THEOPHYLLINE450MGTABLET, EXTENDED RELEASE / ORALAB2025-01-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218401-001THEOPHYLLINE450MGTABLET, EXTENDED RELEASE / ORALAB2025-01-13b8a1b40f171c…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218401-001THEOPHYLLINE450MGTABLET, EXTENDED RELEASE / ORAL2025-01-13a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218401-002THEOPHYLLINE300MGTABLET, EXTENDED RELEASE / ORAL2025-03-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218401-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218401-001AB1b8a1b40f171c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
THEOPHYLLINE ANHYDROUS450 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0I55128JYKInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
314241Internal RxNorm lookup
317769Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7a422c32-bbdf-4297-84f4-9c438c904b0cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1d07c79-5983-427d-b6f5-df0550dcc598Product name420250325
7b1e3dc0-e6b1-4d5d-943b-99fdd948b5a2Product name120170302

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27241-273-01Theophylline100 in 1 BOTTLETABLET, EXTENDED RELEASE1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-273THEOPHYLLINE TABLET, EXTENDED RELEASE [AJANTA PHARMA USA INC.]4Current NDC, 1 package rows20250417_7a422c32-bbdf-4297-84f4-9c438c904b0c.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TheophyllineTHEOPHYLLINEAjanta Pharma USA Inc.7a422c32-bbdf-4297-84f4-9c438c904b0c2025-11-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218401
application number: ANDA218401
ndc (product): 27241-273

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317769theophylline 300 MG Extended Release Oral TabletPSN7a422c32-bbdf-4297-84f4-9c438c904b0c5
314241theophylline 450 MG Extended Release Oral TabletPSN7a422c32-bbdf-4297-84f4-9c438c904b0c5
317769theophylline 300 MG Extended Release Oral TabletSCD7a422c32-bbdf-4297-84f4-9c438c904b0c5
314241theophylline 450 MG Extended Release Oral TabletSCD7a422c32-bbdf-4297-84f4-9c438c904b0c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
27241-273-0127241027301100 TABLET, EXTENDED RELEASE in 1 BOTTLE (27241-273-01) 2025-01-13NoNoCurrent