Theophylline

Product NDC
27808-033
11-digit product format
278080033
Labeler code
27808
Product ID
27808-033_723b1708-84c4-4a42-99bb-475c77bed2ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Theophylline
Dosage form
SOLUTION
Route
ORAL
Labeler
Cranbury Pharmaceuticals, LLC
Application
ANDA091586
Marketing category
ANDA
Marketing start
2012-08-02
Substance
THEOPHYLLINE ANHYDROUS
Active strength
80 mg/15mL
Pharmacologic classes
Methylxanthine [EPC], Xanthines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091586-001THEOPHYLLINETHEOPHYLLINE80MG/15MLSOLUTION / ORALAA2012-06-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091586-001AA

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 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A091586-001THEOPHYLLINE80MG/15MLSOLUTION / ORALAA2012-06-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091586-001THEOPHYLLINE80MG/15MLSOLUTION / ORALAA2012-06-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091586-001THEOPHYLLINE80MG/15MLSOLUTION / ORALAA2012-06-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A091586-001THEOPHYLLINE80MG/15MLSOLUTION / ORALAA2012-06-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091586-001THEOPHYLLINE80MG/15MLSOLUTION / ORALAA2012-06-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091586-001THEOPHYLLINE80MG/15MLSOLUTION / ORALAA2012-06-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091586-001THEOPHYLLINE80MG/15MLSOLUTION / ORALAA2012-06-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091586-001THEOPHYLLINE80MG/15MLSOLUTION / ORALAA2012-06-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091586-001THEOPHYLLINE80MG/15MLSOLUTION / ORALAA2012-06-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091586-001THEOPHYLLINE80MG/15MLSOLUTION / ORALAA2012-06-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091586-001THEOPHYLLINE80MG/15MLSOLUTION / ORALAA2012-06-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091586-001THEOPHYLLINE80MG/15MLSOLUTION / ORALAA2012-06-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091586-001THEOPHYLLINE80MG/15MLSOLUTION / ORALAA2012-06-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091586-001THEOPHYLLINE80MG/15MLSOLUTION / ORALAA2012-06-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091586-001THEOPHYLLINE80MG/15MLSOLUTION / ORALAA2012-06-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091586-001THEOPHYLLINE80MG/15MLSOLUTION / ORALAA2012-06-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091586-001THEOPHYLLINE80MG/15MLSOLUTION / ORALAA2012-06-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091586-001THEOPHYLLINE80MG/15MLSOLUTION / ORALAA2012-06-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091586-001THEOPHYLLINE80MG/15MLSOLUTION / ORALAA2012-06-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091586-001THEOPHYLLINE80MG/15MLSOLUTION / ORALAA2012-06-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091586-001THEOPHYLLINE80MG/15MLSOLUTION / ORALAA2012-06-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091586-001THEOPHYLLINE80MG/15MLSOLUTION / ORALAA2012-06-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A091586-001THEOPHYLLINE80MG/15MLSOLUTION / ORALAA2012-06-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091586-001THEOPHYLLINE80MG/15MLSOLUTION / ORALAA2012-06-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091586-001THEOPHYLLINE80MG/15MLSOLUTION / ORALAA2012-06-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091586-001THEOPHYLLINE80MG/15MLSOLUTION / ORALAA2012-06-153f01610625f2…
2019-09-15 20:21 UTC2019-09A091586-001THEOPHYLLINE80MG/15MLSOLUTION / ORALAA2012-06-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A091586-001THEOPHYLLINE80MG/15MLSOLUTION / ORALAA2012-06-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091586-001THEOPHYLLINE80MG/15MLSOLUTION / ORALAA2012-06-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091586-001THEOPHYLLINE80MG/15MLSOLUTION / ORALAA2012-06-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091586-001THEOPHYLLINE80MG/15MLSOLUTION / ORALAA2012-06-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091586-001THEOPHYLLINE80MG/15MLSOLUTION / ORALAA2012-06-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091586-001THEOPHYLLINE80MG/15MLSOLUTION / ORALAA2012-06-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091586-001THEOPHYLLINE80MG/15MLSOLUTION / ORALAA2012-06-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091586-001THEOPHYLLINE80MG/15MLSOLUTION / ORALAA2012-06-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A091586-001THEOPHYLLINE80MG/15MLSOLUTION / ORALAA2012-06-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A091586-001THEOPHYLLINE80MG/15MLSOLUTION / ORALAA2012-06-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091586-001THEOPHYLLINE80MG/15MLSOLUTION / ORALAA2012-06-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091586-001THEOPHYLLINE80MG/15MLSOLUTION / ORALAA2012-06-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091586-001THEOPHYLLINE80MG/15MLSOLUTION / ORALAA2012-06-15e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A091586-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091586-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091586-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091586-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091586-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091586-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091586-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091586-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091586-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091586-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091586-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091586-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091586-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091586-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091586-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091586-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091586-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091586-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091586-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091586-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091586-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091586-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A091586-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091586-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091586-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091586-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A091586-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A091586-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091586-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091586-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091586-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091586-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091586-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091586-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091586-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A091586-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A091586-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091586-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091586-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091586-001AA1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Theophylline
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
THEOPHYLLINE ANHYDROUS80 mg/15mL

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313306Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
78a99bfe-6ebe-4ace-80b0-ee019921435eAvailable 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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27808-033-01Theophylline473 mL in 1 BOTTLESOLUTION4736

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27808-033-01ML - Milliliter27808-0335c3bf08e-e8ce-44cd-81ec-8de6e07d8fc512014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
THEOPHYLLINE ANHYDROUSACTIVE INGREDIENT0I55128JYKTHEOPHYLLINE SOLUTION [TRIS PHARMA INC]1
THEOPHYLLINE ANHYDROUSACTIVE MOIETY0I55128JYKTHEOPHYLLINE SOLUTION [TRIS PHARMA INC]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLTHEOPHYLLINE SOLUTION [TRIS PHARMA INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTHEOPHYLLINE SOLUTION [TRIS PHARMA INC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TTHEOPHYLLINE SOLUTION [TRIS PHARMA INC]1
ORANGEINACTIVE INGREDIENT5EVU04N5QUTHEOPHYLLINE SOLUTION [TRIS PHARMA INC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTHEOPHYLLINE SOLUTION [TRIS PHARMA INC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3THEOPHYLLINE SOLUTION [TRIS PHARMA INC]1
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYTHEOPHYLLINE SOLUTION [TRIS PHARMA INC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUTHEOPHYLLINE SOLUTION [TRIS PHARMA INC]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRTHEOPHYLLINE SOLUTION [TRIS PHARMA INC]1
SORBITOLINACTIVE INGREDIENT506T60A25RTHEOPHYLLINE SOLUTION [TRIS PHARMA INC]1
WATERINACTIVE INGREDIENT059QF0KO0RTHEOPHYLLINE SOLUTION [TRIS PHARMA INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27808-033THEOPHYLLINE SOLUTION [CRANBURY PHARMACEUTICALS, LLC]6Current NDC, Legacy NDC, 1 package rows20250131_78a99bfe-6ebe-4ace-80b0-ee019921435e.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TheophyllineTHEOPHYLLINEATLANTIC BIOLOGICALS CORP.47e484c2-f59e-4a71-bb97-c90f128ac3452025-12-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091586
application number: ANDA091586
TheophyllineTHEOPHYLLINEBryant Ranch Prepack62fb84a9-4e75-4f4b-8f15-1fd1bb7ae4dd2025-10-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091586
application number: ANDA091586
TheophyllineTHEOPHYLLINEBryant Ranch Prepack955dba5e-c3b7-4a45-8650-e1b4722dbaea2024-11-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091586
application number: ANDA091586
TheophyllineTHEOPHYLLINECranbury Pharmaceuticals, LLC78a99bfe-6ebe-4ace-80b0-ee019921435e2024-08-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091586
application number: ANDA091586
ndc (product): 27808-033

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313306theophylline 80 MG in 15 mL Oral SolutionPSN955dba5e-c3b7-4a45-8650-e1b4722dbaea101
313306theophylline 5.33 MG/ML Oral SolutionSCD955dba5e-c3b7-4a45-8650-e1b4722dbaea101
313306theophylline 100 MG per 18.75 ML Oral SolutionSY955dba5e-c3b7-4a45-8650-e1b4722dbaea101
313306theophylline 80 MG per 15 ML Oral SolutionSY955dba5e-c3b7-4a45-8650-e1b4722dbaea101
313306theophylline 80 MG in 15 mL Oral SolutionPSN62fb84a9-4e75-4f4b-8f15-1fd1bb7ae4dd100
313306theophylline 5.33 MG/ML Oral SolutionSCD62fb84a9-4e75-4f4b-8f15-1fd1bb7ae4dd100
313306theophylline 100 MG per 18.75 ML Oral SolutionSY62fb84a9-4e75-4f4b-8f15-1fd1bb7ae4dd100
313306theophylline 80 MG per 15 ML Oral SolutionSY62fb84a9-4e75-4f4b-8f15-1fd1bb7ae4dd100
313306theophylline 80 MG in 15 mL Oral SolutionPSN78a99bfe-6ebe-4ace-80b0-ee019921435e6
313306theophylline 5.33 MG/ML Oral SolutionSCD78a99bfe-6ebe-4ace-80b0-ee019921435e6
313306theophylline 100 MG per 18.75 ML Oral SolutionSY78a99bfe-6ebe-4ace-80b0-ee019921435e6
313306theophylline 80 MG per 15 ML Oral SolutionSY78a99bfe-6ebe-4ace-80b0-ee019921435e6
313306theophylline 80 MG in 15 mL Oral SolutionPSN47e484c2-f59e-4a71-bb97-c90f128ac3455
313306theophylline 5.33 MG/ML Oral SolutionSCD47e484c2-f59e-4a71-bb97-c90f128ac3455
313306theophylline 100 MG per 18.75 ML Oral SolutionSY47e484c2-f59e-4a71-bb97-c90f128ac3455
313306theophylline 80 MG per 15 ML Oral SolutionSY47e484c2-f59e-4a71-bb97-c90f128ac3455

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
27808-033-0127808003301473 mL in 1 BOTTLE (27808-033-01) 473 ml2012-08-020000-00-00NoNoCurrent