Cimetidine
- Product NDC
- 0093-8305
- 11-digit product format
- 000938305
- Labeler code
- 0093
- Product ID
- 0093-8305_e1f40596-aa5b-46a4-b2aa-add1150ac3a1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cimetidine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA074463
- Marketing category
- ANDA
- Marketing start
- 2003-12-06
- Substance
- CIMETIDINE
- Active strength
- 800 mg/1
- Pharmacologic classes
- Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cimetidine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CIMETIDINE | 800 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 80061L1WGD |
| Rxcui | 197506, 197507, 197508 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0093-8305-01 | Cimetidine | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 11 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CIMETIDINE | ACTIVE INGREDIENT | 80061L1WGD | CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| CIMETIDINE | ACTIVE MOIETY | 80061L1WGD | CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| POVIDONE K25 | INACTIVE INGREDIENT | K0KQV10C35 | CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| POVIDONE K26/28 | INACTIVE INGREDIENT | H7AGY1OJO8 | CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0093-8305 | CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] | 11 | Current NDC, Legacy NDC, 1 package rows | 20230717_496e258d-a5fd-42da-9a86-73afc8be359b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0093-8305-01 | 00093830501 | 100 TABLET, FILM COATED in 1 BOTTLE (0093-8305-01) | 2003-12-23 | 0000-00-00 | No | No | Current |